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Elsevier

Books in Pharmaceutical science

  • Gene and Cell Therapies

    Principles of Pharmaceutical Development
    • 1st Edition
    • Chris Van Der Walle
    • English
    Gene and Cell Therapies: Principles of Pharmaceutical Development explores increasing interest in gene and cell therapies following powerful demonstrations of their capability to treat rare genetic disorders, advanced cancers, and regenerate or repair tissues. Sections cover the design of viral vectors, oncolytic viruses, ribonucleic acid cancer vaccines, and autologous and allogeneic cell therapies, along with impacts on their pharmaceutical development. Advances in molecular and cell biology that have led to efficacious and safe gene and cell therapies are also covered, including their relationship to the process and analytical developments that ensure quality.Gene and Cell Therapies: Principles of Pharmaceutical Development scope and style, along with included case studies, learning points, and lecture slides will allow non-specialists to develop a foundational understanding, while new concepts urge further advancements. Although these new, advanced medicines are continually being improved upon, their complex manufacture remains a key obstacle to increasing patient access.

  • Fundamentals of Biologicals Regulation

    Vaccines and Biotechnology Medicines
    • 2nd Edition
    • Rebecca Sheets + 6 more
    • English
    This second edition of Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. In this new edition the book provides more in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans and REMS, and switching from reliance on in vivo to in vitro analytical methods. This new edition also reflects the new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes for students. This book provides multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions with emphasis on the European Medicines Agency and the U.S. Food and Drug Administration. Graduate students will benefit from the new pedagogic features. Regulatory professionals will have in Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines a complete guide to navigate through the approval process.

  • An Overview of FDA Regulated Products

    From Drugs and Cosmetics to Food and Tobacco
    • 2nd Edition
    • Eunjoo Pacifici + 1 more
    • English
    An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, Second Edition is fully updated to reflect recent advances in science and technology and new laws and regulations. Breakthroughs in cellular and gene therapy, immunotherapy, precision medicine, and digital health are changing the face of healthcare and regulation. The updates brought about by the 21st Century Cures Act and subsequent PDUFA Reauthorizations, as well as signing into law the “Modernization of Cosmetic Regulation Act of 2022,” which will transform FDA’s oversight of cosmetics, are fully reflected in all chapters of the book.This book provides graduate students and industry professionals with comprehensive information on approval processes with the FDA and other country regulation organizations. Regulatory science professionals working with not only drugs, but biologics, medical devices, food and additives, cosmetics, veterinary products, and tobacco will benefit from this comprehensive overview of the regulatory environment.

  • Reproducibility in Biomedical Research

    Epistemological and Statistical Problems and the Future
    • 2nd Edition
    • Erwin B. Montgomery Jr.
    • English
    Reproducibility in Biomedical Research: Epistemological and Statistical Problems, Second Edition explores the ideas and conundrums inherent in scientific research. This second edition addresses new challenges to reproducibility in biosciences, namely reproducibility of machine learning Artificial Intelligence (AI), reproducibility of translation from research to medical care, and the fundamental challenges to reproducibility. All current chapters are expanded to cover advances in the topics previously addressed. This book provides biomedical researchers with a framework to better understand the reproducibility challenges in the area. Newly introduced interactive exercises and updated case studies help students understand the fundamental concepts involved in the area.

  • Dosage Forms, Formulation Developments and Regulations

    Recent and Future Trends in Pharmaceutics, Volume 1
    • 1st Edition
    • Amit Kumar Nayak + 1 more
    • English
    Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics.

  • From Current to Future Trends in Pharmaceutical Technology

    • 1st Edition
    • Natassa Pippa + 2 more
    • English
    From Current to Future Trends in Pharmaceutical Technology explores the current trends of this field and creates a multi-aspect framework for the reader. The book covers topics on pharmaceutics, pharmaceutical engineering, pre-formulation protocols, techniques, innovative excipients, bio-printing techniques, scale-up based on formulas on-a-chip, and regulatory aspects based on new scientific achievements. Modified dosage forms, new aspects on the compatibility of drug excipients interactions, and drug release by various dosage forms are included. Physical pharmacy (physical and biological stability of dosage forms), innovative excipients, patents on innovative formulations and regulatory issues related to the approval process of medicines are also discussed. The book is a valuable resource for a wide audience of academics, industrial researchers and professionals working in this field as the development of efficient and safe medicines is critical to future needs.

  • Pharmaceutical Care in Digital Revolution

    Blending Digital with Human Innovation
    • 2nd Edition
    • Ardalan Mirzaei + 1 more
    • English
    Pharmaceutical Care in the Digital Revolution: Blending Digital with Human Innovation, Second Edition provides readers with an updated view on how to use technology to improve pharmaceutical care (PC) and enhance drug outcomes with digital tools. Organized into four parts, including Global Healthcare Systems Under Pressure, Digital Advances to Innovate Pharmaceutical Care Journeys, Conditions to Drive Combinatoric Pharma-Digital Innovation, and What to do Tomorrow as a Pharmaceutical Care Leader, the book further examines digital developments that will optimize the PC process and prepare stakeholders for a dynamic future that will optimize the life of patients against a sustainable cost model. This edition also discusses recent advances in the digital health arena that will change the way we approach healthcare and prevention while also providing interactive links to lectures and technologies, tutorials on how to implement advances in your own working environment, and examples of pharmacists who are successful in building synergy between digital and pharma.

  • Surfactants in Biopharmaceutical Development

    • 1st Edition
    • Atanas V. Koulov + 1 more
    • English
    Surfactants in Biopharmaceutical Development addresses the progress, challenges, and opportunities in surfactant research in the context of the development of biologic therapeutics. It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses, which is the reason that nearly all therapeutic proteins in development and on the market today contain surfactants. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients for biopharmaceuticals by the industry and by regulators.This book provides a broad range of important surfactant-related topics as they relate directly to biopharmaceutical development. The initial chapters of the book address fundamental topics, like synthesis of surfactants, mechanisms of protein stabilization by surfactants, as well as practical considerations for the use of surfactants in biomanufacturing. Later chapters provide overview of the state-of-the-art analytical technology and methods for quantification and characterization of surfactants, as well as a deep-dive in one of the hottest topics in biopharmaceutical development today – surfactant degradation and its impact to drug product quality and stability. The book concludes with forward-looking chapters on control strategies with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators.

  • Phytonutrients and Neurological Disorders

    Therapeutic and Toxicological Aspects
    • 1st Edition
    • Haroon Khan + 2 more
    • English
    Phytonutrients and Neurological Disorders: Therapeutic and Toxicological Aspects provides and assesses the latest research and developments surrounding the use of phytonutrients for the treatment of neurological disorders. The volume analyzes advances in phytonutrient isolation, characterization and therapeutic applications, giving particular emphasis to mechanisms and safety profiles. The book takes toxicological considerations into account, including adverse drug reactions, toxicokinetics and toxicodynamics. Sections cover bioactive compound classes and biosynthesis pathways, general considerations, including quality control, standardization, and technology, and toxicology. This title is a comprehensive work on the latest research in phytonutrients and neurological disorders that will be useful to researchers and medical practitioners.

  • Overcoming Obstacles in Drug Discovery and Development

    Surmounting the Insurmountable—Case Studies for Critical Thinking
    • 1st Edition
    • Kan He + 2 more
    • English
    Overcoming Obstacles in Drug Discovery and Development uses real-world case studies to illustrate how critical thinking and problem solving skills are applied in the discovery and development of drugs. It also shows how developing critical thinking to overcome issues plays an essential role in the process. Modern drug discovery and development is a highly complex undertaking that requires scientific and professional expertise to be successful. After the identification of a molecular entity for treating a medical condition, challenges inevitably arise during the subsequent development to understand and characterize the biological profile; feedback from scientists is used to fine-tune the molecular entity to obtain an effective and safe product. In this process, the discovery team may identify unexpected safety issues and new medical disorders for treatment by the molecular entity. Invariably inherent in this complex undertaking are miscues, mistakes, and unexpected problems that can derail development and throw timetables into disarray, potentially leading to failure in the development of a medically useful drug. Addressing critical unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills. Overcoming Obstacles in Drug Discovery and Development will be essential to young scientists to help learn the skills to successfully face challenges, learn from mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from the case studies of successful and unsuccessful drug development.

  • Managing the Drug Discovery Process

    Insights and advice for students, educators, and practitioners
    • 2nd Edition
    • Susan Miller + 5 more
    • English
    Managing the Drug Discovery Process, Second Edition thoroughly examines the current state of pharmaceutical research and development by providing experienced perspectives on biomedical research, drug hunting and innovation, including the requisite educational paths that enable students to chart a career path in this field. The book also considers the interplay of stakeholders, consumers, and drug firms with respect to a myriad of factors. Since drug research can be a high-risk, high-payoff industry, it is important to students and researchers to understand how to effectively and strategically manage both their careers and the drug discovery process. This new edition takes a closer look at the challenges and opportunities for new medicines and examines not only the current research milieu that will deliver novel therapies, but also how the latest discoveries can be deployed to ensure a robust healthcare and pharmacoeconomic future. All chapters have been revised and expanded with new discussions on remarkable advances including CRISPR and the latest gene therapies, RNA-based technologies being deployed as vaccines as well as therapeutics, checkpoint inhibitors and CAR-T approaches that cure cancer, diagnostics and medical devices, entrepreneurship, and AI. Written in an engaging manner and including memorable insights, this book is aimed at anyone interested in helping to save countless more lives through science. A valuable and compelling resource, this is a must-read for all students, educators, practitioners, and researchers at large—indeed, anyone who touches this critical sphere of global impact—in and around academia and the biotechnology/pharma... industry.

  • Medicinal Chemistry of Chemotherapeutic Agents

    A Comprehensive Resource of Anti-infective and Anti-cancer Drugs
    • 1st Edition
    • Pratap Chandra Acharya + 1 more
    • English
    Medicinal Chemistry of Chemotherapeutic Agents: A Comprehensive Resource of Anti-infective and Anti-cancer Drugs focuses on the basics and fundamentals of chemistry involved in chemotherapeutic agents. Each chapter comprises distinct chemical classifications that include structure and IUPAC nomenclature, synthetic schemes and routes for each drug, mechanism of the drug action, metabolic pathway and structure–activity relationship (SAR) studies. The book covers current research focused on drug resistance and methods to overcome it, the development of newer drugs belonging to each category of the chemotherapeutic agents, molecules currently under clinical trials, and newly approved drugs, if any. This book will be a valuable resource for academics and researchers, helping them to understand the fundamentals of the medicinal chemistry of the chemotherapeutic agents.

  • Laboratory Animal Anaesthesia and Analgesia

    • 5th Edition
    • Paul Flecknell
    • English
    Laboratory Animal Anaesthesia and Analgesia, Fifth Edition provides a basic guide to anesthesia for a very diverse audience involved in animal testing. This has been the go-to resource for current, clear and evidence-based information for over 30 years. The book is divided into four parts that deal with preparation for anesthesia, including definitions, equipment, preparations, anesthetic and analgesic agents, the management and monitoring of anesthesia, including pre-procedural preparations, monitoring and problems and emergencies through the procedure, advanced and specialized techniques, and analgesia and post-operative care, including recovery and the prevention and management of post-operative pain. Final sections cover anesthesia in common laboratory species, specifically: rodents, rabbits, cats, dogs, ferrets, pigs, sheep and goats, primates, reptiles, amphibians and new specific chapters on birds, fish and cephalopods. This edition keeps up with the tradition of bringing a balanced dose of practical advice, foundational content, and current, updated references, drugs and procedures to veterinarians, technicians, researchers and ethics committee personnel.

  • Nanocosmeceuticals

    Innovation, Application, and Safety
    • 1st Edition
    • Malay K. Das
    • English
    Cosmetics are a fast-growing segment in the global personal care industry and the application of nanocosmeceuticals are on the rise. Conventional cosmetics greatly lack specific delivery systems, prolong effects and relatively heavy doses may be necessary. One of the common complaints of consumers is rather short-term activity of cosmetics, especially in face care products.Nanocosmece... having more advanced nutrient delivery mechanisms, carry more task specific nutrients to the skin deep where it can be metabolized and used to nourish cells. It can help to increase the aesthetic appeal of a product influencing the purchase decision of a consumer. Nanocosmeceuticals: Innovation, Application and Safety highlights the trends and applications of nanotechnology in cosmeceuticals for more advance and task specific nutrients delivery and long term effects of personal care products using liposome, solid lipid nanoparticles, nanostructured lipid carriers, transferosomes, niosomes, phytosomes, nanoemulsions, silver nanoparticles, chitin nanofibrils etc. It also provides the detailed information on regulatory laws, safety and marketing aspects of cosmeceuticals.This book offers an indispensable guide for professors, researchers, students, formulation chemists as well as formulation scientists in academia and industry; beauticians and decision-makers in consumer organizations.

  • Computational Approaches for Novel Therapeutic and Diagnostic Designing to Mitigate SARS-CoV2 Infection

    Revolutionary Strategies to Combat Pandemics
    • 1st Edition
    • Arpana Parihar + 4 more
    • English
    Computational Approaches for Novel Therapeutic and Diagnostic Designing to Mitigate SARS-CoV2 Infection: Revolutionary Strategies to Combat Pandemics compiles information about various computational bioinformatic approaches that can help combat viral infection. The book includes working knowledge of various molecular docking and molecular dynamic simulation approaches that have been exploited for drug repurposing and drug designing purpose. In addition, it sheds light on reverse vaccinomics and immunoinformatic approaches for vaccine designing against SARS-CoV2 infection. This book is an essential resource for researchers, bioinformaticians, computational biologists, computational chemists and pharmaceutical companies who are working on the development of effective and specific therapeutic interventions and point-of-care diagnostic devices using various computational approaches.

  • The Role of Phytonutrients in Metabolic Disorders

    • 1st Edition
    • Haroon Khan + 2 more
    • English
    The Role of Phytonutrients in Metabolic Disorders provides the information readers need to conduct research on phytonutrients in metabolic disorders. The book presents the treatment of metabolic diseases using phytonutrients, the key regulatory mechanisms of phytonutrients in metabolic pathways, and evaluates phytonutrients as a source of new drug candidate molecules. The book compiles and evaluates the very latest findings and therapeutic developments in the management of various metabolic disorders, their underlying mechanisms, and the clinical potential and limitations of phytonutrients. Thirteen chapters illustrate the therapeutic potential of phytonutrients in the management of various metabolic disorders through the regulation of signaling pathways.

  • Antioxidants Effects in Health

    The Bright and the Dark Side
    • 1st Edition
    • Seyed Mohammad Nabavi + 1 more
    • English
    Antioxidants Effects in Health: The Bright and the Dark Side examines the role that antioxidants play in a variety of health and disease situations. The book discusses antioxidants’ historical evolution, their oxidative stress, and contains a detailed approach of 1) endogenous antioxidants, including endogenous sources, mechanisms of action, beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies; 2) synthetic antioxidants, including sources, chemistry, bioavailability, legal status, mechanisms of action, beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies; and 3) natural antioxidants, including sources, chemistry, bioavailability, mechanisms of action, possible prooxidant activity; beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies. Throughout the boo, the relationship of antioxidants with different beneficial and detrimental effects are examined, and the current controversies and future perspectives are addressed and explored. Antioxidants Effects in Health: The Bright and the Dark Side evaluates the current scientific evidence on antioxidant topics, focusing on endogenous antioxidants, naturally occurring antioxidants and synthetic antioxidants. It will be a helpful resource for pharmaceutical scientists, health professionals, those studying natural chemistry, phytochemistry, pharmacognosy, natural product synthesis, and experts in formulation of herbal and natural pharmaceuticals.

  • Photophysics and Nanophysics in Therapeutics

    • 1st Edition
    • Nilesh M. Mahajan + 3 more
    • English
    Photophysics and Nanophysics in Therapeutics explores the latest advances and applications of phototherapy and nanotherapy, covering the application of light, radiation, and nanotechnology in therapeutics, along with the fundamental principles of physics in these areas. Consisting of two parts, the book first features a range of chapters covering phototherapeutics, from the fundamentals of photodynamic therapy (PDT) to applications such as cancer treatment and advances in radiotherapy, applied physics in cancer radiotherapy treatment, and the role of carbon ion beam therapy. Other sections cover nanotherapeutics, potential applications and challenges, and nanotherapy for drug delivery to the brain. Final chapters delve into nanotechnology in the diagnosis and treatment of cancers, the role of nanocarriers for HIV treatment, nanoparticles for rheumatoid arthritis treatment, peptide functionalized nanomaterials as microbial sensors, and theranostic nanoagents.

  • How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems

    • 1st Edition
    • Fernando Muzzio + 1 more
    • English
    How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.

  • Formulation and Device Lifecycle Management of Biotherapeutics

    A Guidance for Researchers and Drug Developers
    • 1st Edition
    • Beate Bittner + 1 more
    • English
    Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-relat... healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution.

  • Practical Aspects of Vaccine Development

    • 1st Edition
    • Parag Kolhe + 1 more
    • English
    Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and challenges being encountered. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges. Vaccines include a wide range of components including proteins, polysaccharides, protein-polysacchari... conjugates, adjuvants, and more. The container closure system may also be unique, and the product may require freezing storage or lyophilization based on the stability of the vaccine components. Based on the route of delivery, novel technologies and devices may be required. Covering formulation development, manufacture, and delivery considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students.

  • Cancer Immunology and Immunotherapy

    Volume 1 of Delivery Strategies and Engineering Technologies in Cancer Immunotherapy
    • 1st Edition
    • Mansoor M. Amiji + 1 more
    • English
    Delivery Technologies for Immuno-Oncology: Volume 1: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy examines the challenges of delivering immuno-oncology therapies. Immuno-oncology (IO) is a growing field of medicine at the interface of immunology and cancer biology leading to development of novel therapeutic approaches, such as chimeric antigen receptor T-cell (CAR-T) and immune checkpoint blockade antibodies, that are clinically approved approaches for cancer therapy. Although currently approved IO approaches have shown tremendous promise for select types of cancers, broad application of IO strategies could even further improve the clinical success, especially for diseases such as pancreatic cancer, brain tumors where the success of IO so far has been limited. Nanotechnology-based targeted delivery strategies could improve the delivery efficiency of IO agents as well as provide additional avenues for novel therapeutic and vaccination strategies. Additionally, a number of locally-administered immunogenic scaffolds and therapeutic strategies, such as the use of STING agonist, could benefit from rationally designed biomaterials and delivery approaches. Delivery Technologies for Immuno-Oncology: Volume 1: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy creates a comprehensive treaty that engages the scientific and medical community who are involved in the challenges of immunology, cancer biology, and therapeutics with possible solutions from the nanotechnology and drug delivery side.

  • Principles of Translational Science in Medicine

    From Bench to Bedside
    • 3rd Edition
    • Martin Wehling
    • English
    Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields.

  • Biopharmaceutics and Pharmacokinetics Considerations

    • 1st Edition
    • English
    Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce.

  • Global Perspectives on Astaxanthin

    From Industrial Production to Food, Health, and Pharmaceutical Applications
    • 1st Edition
    • Gokare A. Ravishankar + 1 more
    • English
    Global Perspectives on Astaxanthin: From Industrial Production to Food, Health, and Pharmaceutical Applications explores the range of practical applications for this molecule, focusing on nutraceutical, pharmaceutical and cosmeceutical products, along with food and feed. This volume brings together the most relevant research, background and future thinking on astaxanthin, focusing on its health benefits. Chapters cover phytopharmaceuticals... industrial production, feeds, downstream processing, regulations, products, color, pigment, cosmetics, bioactive compounds, relationships to other carotenoids, and skin care. The detailed information on its production, processing, utilization and future applications will be of particular use to academic and industry researchers in pharmaceutical sciences, pharmacology and nutrition.

  • Inhaled Medicines

    Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches
    • 1st Edition
    • Stavros Kassinos + 3 more
    • English
    Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes. Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments.

  • Preparation of Phytopharmaceuticals for the Management of Disorders

    The Development of Nutraceuticals and Traditional Medicine
    • 1st Edition
    • Chukwuebuka Egbuna + 2 more
    • English
    Preparation of Phytopharmaceuticals for the Management of Disorders: The Development of Nutraceuticals and Traditional Medicine presents comprehensive coverage and recent advances surrounding phytopharmaceuticals... nutraceuticals and traditional and alternative systems of medicines. Sections cover the concepts of phytopharmaceuticals... their history, and current highlights in phytomedicine. Also included are classifications of crude drugs, herbal remedies and toxicity, traditional and alternative systems of medicine, nanotechnology applications, and herbal cosmeticology. Final sections cover applications of microbiology and biotechnology in drug discovery. This book provides key information for everyone interested in drug discovery, including medicinal chemists, nutritionists, biochemists, toxicologists, drug developers and health care professionals. Students, professors and researchers working in the area of pharmaceutical sciences and beyond will also find the book useful.

  • Clinical Perspectives and Targeted Therapies in Apoptosis

    Drug Discovery, Drug Delivery, and Disease Prevention
    • 1st Edition
    • Rupinder K. Sodhi + 1 more
    • English
    Clinical Perspectives and Targeted Therapies in Apoptosis: Drug Discovery, Drug Delivery, and Disease Prevention provides comprehensive coverage, from basic cell biology, to modern assessment techniques for apoptosis in all major disease areas. Chapters provide an introduction to the fundamentals of cell biology, biochemical mechanisms, and the pathophysiological consequences of apoptosis. In addition, the book covers the tools and techniques used to quantify apoptosis and the significance of apoptosis in drug discovery, drug delivery, and its applications in disease prevention. Finally, the book provides a comprehensive compilation of the apoptosis targeting drugs that recently underwent clinical trials. This combination of fundamentals, along with applications in drug discovery, drug delivery, and clinical research make this book a useful resource for those in both academia and industry who are engaged in pharmaceutical, biomedical and biotechnology research.

  • Theory and Applications of Nonparenteral Nanomedicines

    • 1st Edition
    • Prashant Kesharwani + 2 more
    • English
    Theory and Applications of Nonparenteral Nanomedicines presents thoroughly analysed data and results regarding the potential of nanomedicines conceived by diverse non-parenteral routes. In the context of nanotechnology-based approaches, various routes such as oral, pulmonary, transdermal, delivery and local administration of nanomedicine have been utilized for the delivery of nanomedicine. This book discusses the non-parenteral application of nanomedicine, its regulatory implications, application of mucus penetrating nanocarrier, and detailed chapters on development of nanomedicines developed for drug delivery by various route. Beginning with a brief introduction to the non-parenteral delivery of nanomedicine and the safety and regulatory implications of the nanoformulations, further chapters discuss the physiology of the biological barriers, the specificity of the nanocarriers as well as their multiple applications. Theory and Applications of Nonparenteral Nanomedicines helps clinical researchers, researchers working in pharmaceutical industries, graduate students, and anyone working in the development of non-parenteral nanomedicines to understand the recent progress in the design and development of nanoformulations compatible with non-parenteral applications.

  • The Future of Pharmaceutical Product Development and Research

    • 1st Edition
    • English
    The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals... and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries.

  • Molecular Evolutionary Models in Drug Discovery

    • 1st Edition
    • Juan Bueno
    • English
    Molecular Evolutionary Models in Drug Discovery explores the application of evolutionary molecular models in drug discovery in which secondary metabolites play a fundamental role. Secondary metabolites are not produced in isolation, they are the result of the interaction of genes, metabolism and the environment. The book examines the role of secondary metabolites as leads in drug discovery and on the development of a rational bioprospecting model for new medicines based on the evolution of secondary metabolism. These evolutionary models are part of biological systems and are the most reliable expression of the functioning of living beings.

  • Light, Molecules, Reaction and Health

    • 1st Edition
    • Angelo Albini
    • English
    Light, Molecules, Reaction and Health offers a comprehensive overview of health-related, light-based processes and systems, paying special attention to molecular photochemistry. Users of photochemical methods and concepts in pharmacology and biomedicine will find detailed information on the basic processes underlying the biological effects of natural and artificial light—from the primary absorption event occurring in an endogenous or exogenous molecule in a biological compartment, to the final pathological or beneficial outcome. By emphasizing novel methods, including nanostructured materials in therapy and diagnostics, this book allows readers to critically interpret existing data with a goal of stimulating new research in phytotherapy and phytomedicine.

  • Principles of Parenteral Solution Validation

    A Practical Lifecycle Approach
    • 1st Edition
    • Igor Gorsky + 1 more
    • English
    Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area.

  • Drug Delivery Systems

    • 1st Edition
    • English
    Drug Delivery Systems examines the current state of the field within pharmaceutical science and concisely explains the history of drug delivery systems, including key developments. The book translates the physicochemical properties of drugs into drug delivery systems administered via various routes, such as oral, parenteral, transdermal and inhalational. Regulatory and product development topics are also explored. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of drug delivery systems within the pharmaceutical sciences industry and research, as well as in chemical engineering. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists. This book provides a comprehensive examination that is suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnologies, and related industries.

  • Polymeric Nanoparticles as a Promising Tool for Anti-cancer Therapeutics

    • 1st Edition
    • Prashant Kesharwani + 2 more
    • English
    Polymeric Nanoparticles as Promising Tool for Anti-cancer Therapeutics provides an understanding of polymeric compounds and their use in cancer therapies. The book begins by giving an overview of the current status, future challenges and potential utilization of polymeric nanoparticles. It then covers specific polymeric nanoparticles through contributions from world-renowned experts and researchers. Chapters examine specific polymeric nanoparticles, their development as potential targeted delivery systems, and cancer characteristics that can be targeted for therapy development. The book synthesizes current research trends in the field, thus enhancing existing knowledge of nanomedicine, drug delivery and therapeutic intervention strategies in human cancers. Users will find this to be an ideal reference for research scientists and those in the pharmaceutical and medical fields who are working to develop novel cancer therapies using nanoparticle-based delivery systems.

  • Equipment Qualification in the Pharmaceutical Industry

    • 1st Edition
    • Steven Ostrove
    • English
    Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

  • Biomarkers, Diagnostics and Precision Medicine in the Drug Industry

    Critical Challenges, Limitations and Roadmaps for the Best Practices
    • 1st Edition
    • Abdel Halim
    • English
    The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-... and for-research-use-onl... assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management.

  • The Core Model

    A Collaborative Paradigm for the Pharmaceutical Industry and Global Health Care
    • 1st Edition
    • Ibis Sanchez Serrano
    • English
    The Core Model: A Collaborative Paradigm for the Pharmaceutical Industry and Global Health Care develops the innovative core model, an organizational research and design paradigm and economic theory that proposes a collaborative approach to resolving global health issues and improving the productivity of drug development. The model proposes that scientific collaboration does not occur in an unstructured manner, but actually takes place within a highly structured order where knowledge is transferred, integrated and finally translated into commercial products. An understanding of this model will help solve the global pharmaceutical industry´s productivity problems and address important global health care and economic issues. This book is useful to researchers, advanced students, regulators, and management in pharmaceutical industries, as well as healthcare professionals, those working in health economics, and those interested in scientific innovation processes.

  • NETosis

    Immunity, Pathogenesis and Therapeutics
    • 1st Edition
    • Geeta Rai
    • English
    NETosis: Immunity, Pathogenesis and Therapeutics takes a focused approach to the clinical aspects of NETosis and drug development, bringing critical findings. Chapters introduce NETosis, consider mechanisms and antimicrobial strategies regulating NETosis, examine NETosis in neonates, explore the role of NETosis in autoimmunity, delve into NETosis and other diseases, and present therapeutic approaches for dysregulated NETosis. Since Brinkamm, et al, discovered an unrecognized neutrophil anti-microbial mechanism responsible for the extracellular killing of invading pathogens in 2004, the novel process in which nuclear chromatin de-condenses and DNA is ejected into the extra cellular environment, trapping and inactivating tissue pathogens has rapidly evolved.

  • Biomaterials and Bionanotechnology

    • 1st Edition
    • English
    Biomaterials and Bionanotechnology examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biomaterials and bionanotechnology within drug discovery and drug development. Each chapter delves into a particular aspect of this fast-moving field to cover the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable dosage form, with particular focus on biomaterials and bionanomaterials. This book provides a comprehensive examination suitable for researchers working in the pharmaceutical, cosmetics, biotechnology, food and related industries as well as advanced students in these fields.

  • New Developments in Nanosensors for Pharmaceutical Analysis

    • 1st Edition
    • Sibel A. Ozkan + 1 more
    • English
    New Developments for Nanosensors in Pharmaceutical Analysis presents an overview of developments in nanosensor usage in pharmaceutical analysis, thereby helping pharmaceutical companies attain reliable, precise, and accurate analysis of pharmaceuticals. This book presents very simple, precise, sensitive, selective, fast, and relatively inexpensive methods for pre-treatment, prior to analysis. These methods may be considered for further application in clinical studies and assays. The book includes the manufacturing of sensors for pharmaceutical analysis at nano- or smaller scales, and gives simple and relatable designs for the fabrication of sensors. Twelve chapters cover an introduction to the topic, immobilization techniques, mechanism effect of nanomaterials on structure, optical nanosensors for pharmaceutical detection, chemical nanosensors in pharmaceutical analysis, noble metal nanoparticles in electrochemical analysis of drugs, photo-electrochemica... nanosensors for drug analysis, molecularly imprinted polymer based nanosensors for pharmaceutical analysis, nanomaterials for drug delivery systems, nanomaterials enriched nucleic acid-based biosensors, nanosensors in biomarker detection, and nanomaterials-based enzyme biosensors for electrochemical applications.

  • Companion and Complementary Diagnostics

    From Biomarker Discovery to Clinical Implementation
    • 1st Edition
    • Jan Trøst Jørgensen
    • English
    Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies.

  • Quorum Sensing

    Molecular Mechanism and Biotechnological Application
    • 1st Edition
    • Giuseppina Tommonaro
    • English
    Quorum sensing (QS) is a process of bacterial cooperative behaviour that has an effect on gene regulation. This cell-to-cell communication system involves the production of signalling molecules according to cell density and growth stage. Virulence, the ability to infest a habitat and cause disease, is also governed by such communication signals. Quorum Sensing: Molecular mechanism and biotechnological application collects, describes and summarizes the most interesting results obtained from experts working on QS mechanisms. It contributes to the understanding of the molecular basis that regulates this mechanism, and describes new findings in fields of application. This volume describes the QS mechanism from its molecular basis to medical applications such as antibiotic therapy and involvement of QS in pathologies. This reference also analyzes its potential use in biotechnological applications such as food packaging, drug delivery, and marine biofilm. The broad scope of this title will be of significant use to researchers across several fields with interest in QS, including to microbiologists, chemists, biochemists and ecologists.

  • Nanotechnology-Based Targeted Drug Delivery Systems for Lung Cancer

    • 1st Edition
    • Prashant Kesharwani
    • English
    Nanotechnology-based Targeted Drug Delivery Systems for Lung Cancer is an indispensable resource that will help pharmaceutical scientists and clinical researchers design and develop novel drug delivery systems and devices for the treatment of lung cancer. As recent breakthroughs in nanomedicine are now making it possible to deliver drugs, genes and therapeutic agents to localized areas of disease to maximize clinical benefit, while also limiting unwanted side effects, this book explores promising approaches for the diagnosis and treatment of lung cancer using cutting-edge nanomedical technologies. Topics discussed include polymeric nanoparticles, solid lipid nanoparticles, liposomes, dendrimers, micelles and nanoemulsions.

  • Biocontamination Control for Pharmaceuticals and Healthcare

    • 1st Edition
    • Tim Sandle
    • English
    Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy.

  • New Look to Phytomedicine

    Advancements in Herbal Products as Novel Drug Leads
    • 1st Edition
    • Mohd Sajjad Ahmad Khan + 2 more
    • English
    New Look to Phytomedicine: Advancements in Herbal Products as Novel Drug Leads is a compilation of in-depth information on the phytopharmaceuticals used in modern medicine for the cure and management of difficult-to-treat and challenging diseases. Readers will find cutting-edge knowledge on the use of plant products with scientific validation, along with updates on advanced herbal medicine in pharmacokinetics and drug delivery. This authoritative book is a comprehensive collection of research based, scientific validations of bioactivities of plant products, such as anti-infective, anti-diabetic, anti-cancer, immune-modulatory and metabolic disorders presented by experts from across the globe. Step-by-step information is presented on chemistry, bioactivity and the functional aspects of biologically active compounds. In addition, the pharmacognosy of plant products with mechanistic descriptions of their actions, including pathogenicity is updated with information on the use of nanotechnology and molecular tools in relation to herbal drug research.

  • Advanced Issue Resolution in Safety Pharmacology

    • 1st Edition
    • Mary Jeanne Kallman + 1 more
    • English
    Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.

  • Dosage Form Design Considerations

    Volume I
    • 1st Edition
    • English
    Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.

  • Dosage Form Design Parameters

    Volume II
    • 1st Edition
    • English
    Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.

  • Accelerated Predictive Stability (APS)

    Fundamentals and Pharmaceutical Industry Practices
    • 1st Edition
    • Fenghe Qiu + 1 more
    • English
    Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly.