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Elsevier

Books in Pharmaceutical sciences

Elsevier's Pharmaceutical Sciences collection helps pharmaceutical scientists striving to optimize drug design and improve healthcare outcomes by offering comprehensive coverage of every aspect of drug development, integrating disciplines like organic chemistry, biology, and biotechnology. Focused on safety, efficacy, and formulation design, it includes specialized fields such as Clinical Pharmacology and Translational Research, providing valuable insights into the latest advancements in drug discovery.

  • Mosby's Sterile Compounding for Pharmacy Technicians

    Principles and Practice
    • 2nd Edition
    • Karen Davis
    • English
    Gain a complete introduction to institutional pharmacy practice and efficiently prepare for the new sterile compounding certification exam! Comprehensively covering sterile products, aseptic technique, and the workings of the sterile compounding facility, Mosby’s Sterile Compounding for Pharmacy Technicians: Principles and Practice, 2nd Edition, focuses on safe and accurate practice. This edition has expanded and updated coverage to address preparation, processing, medications, technique, and documentation, with review, analysis, and application of <USP 797>, <USP 800>, and <USP 825> and additional content on waste management, workflow, safety and compliance, billing and reimbursement, and emergency management. Illustrations abound, and content is brought to life with an updated art program, step-by-step procedures, and technician notes and alerts. Certification review questions are included with each chapter, and online student and instructor resources round out the offering.

  • 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.

  • Side Effects of Drugs Annual

    • 1st Edition
    • Volume 41
    • Sidhartha D. Ray
    • English
    Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Volume 41, first published in 1977, and continually published as a yearly update to the voluminous encyclopedia Meyler's Side Effects of Drugs, presents clinicians and medical investigators with a critical survey of new data and trends in adverse drug reactions and interactions. Topics covered in this new release include Central Nervous System Stimulants and Drugs that Suppress Appetite, Antidepressants, Lithium, Drugs of Abuse, Hypnotics and Sedatives, Antipsychotic Drugs, Antiepileptics, Opioid Analgesics and Narcotic Antagonists, Anti-Inflammatory and Antipyretic Analgesics and Drugs Used in Gout, and much more.

  • 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.

  • Emergence of Pharmaceutical Industry Growth with Industrial IoT Approach

    • 1st Edition
    • Valentina Emilia Balas + 2 more
    • English
    Emergence of Pharmaceutical Industry Growth with Industrial IoT Approach uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches, create efficiencies and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Pharmaceutical manufacturing companies are no exception to this, as IoT has the potential to revolutionize aspects of the pharmaceutical manufacturing process, from drug discovery to manufacturing. Using clear, concise language and real world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety of topics presented offers readers multiple perspectives on a how to integrate the Internet of Things into pharmaceutical manufacturing.

  • How to Integrate Quality by Efficient Design (QbED) in Product Development

    • 1st Edition
    • Bhavishya Mittal
    • English
    The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management.

  • Natural Polysaccharides in Drug Delivery and Biomedical Applications

    • 1st Edition
    • Md Saquib Hasnain + 1 more
    • English
    Natural Polysaccharides in Drug Delivery and Biomedical Applications provides a fundamental overview of natural polysaccharides, their sources, extraction methodologies, and characterizations. It covers specific natural polysaccharides and their effective application in drug delivery and biomedical use. Additionally, chapters in the book discuss key topics including the sources and extraction methodologies of natural polysaccharides, their role in tissue engineering applications, polysaccharide-based nanoparticles in biomedical applications, and their role in the delivery of anticancer drugs. Written by industry leaders and edited by experts, this book emphasizes recent advances made in the field.Natural Polysaccharides in Drug Delivery and Biomedical Applications provides academics, researchers, and pharmaceutical health care professionals with a comprehensive book on polysaccharides in pharmaceutical delivery process.

  • Math Calculations for Pharmacy Technicians custom e-book for Ross education (3e)

    • 3rd Edition
    • Ross Education
    • English

  • Mosby’s Pharmacy Technician Exam Review

    • 4th Edition
    • James J. Mizner
    • English
    Prepare for success on your certification exam! Mosby's Pharmacy Technician Exam Review, 4th Edition provides a complete review of core knowledge, thousands of review questions, and nine practice exams – plus a custom online engine that allows for unlimited opportunities to practice specific topics or create unique simulated exams. A bulleted, outline format makes review easier, reinforcing understanding with full-color illustrations, photographs, and summary tables. All questions reflect the latest exam blueprints. This resource provides you comprehensive support every step of the way for entry-level or sterile compounding certification.

  • 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.

  • Pharmaceutical Quality by Design

    Principles and Applications
    • 1st Edition
    • Sarwar Beg + 1 more
    • English
    Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process.

  • Pharmaceutical Care in Digital Revolution

    Insights Towards Circular Innovation
    • 1st Edition
    • Claudia Rijcken + 1 more
    • English
    Pharmaceutical Care in Digital Revolution demonstrates how blending human and digital pharmaceutical care can establish optimal Apothecary Intelligence (AI). Organized into four parts, it examines digital health advances that will synergize the pharmaceutical care process and prepares stakeholders for a dynamic future, fueled with innovation. Beginning with the global picture on health care systems, patients’ expectations, and current pharmaceutical care practices, the book covers details of relevant digital technologies as well as compliance, ethical, educational, and cultural aspects to take successful steps towards digital pharmaceutical care. The text includes links to lectures and technology facts, tutorials on how to implement advances in your own working environment, and examples of stakeholders who are successful in building synergy between digital and pharma. Pharmaceutical Care in Digital Revolution is a practical resource to equip pharmaceutical care stakeholders, such as pharmacists, physicians, pharmacy technicians, and students as well as those in surrounding ecosystems like payers or regulators. It is a crucial reference to understand how technological innovation is changing the paradigm in which we provide current and future pharmaceutical care and how to keep it accessible, affordable, and sustainable.

  • In Silico Drug Design

    Repurposing Techniques and Methodologies
    • 1st Edition
    • Kunal Roy
    • English
    In Silico Drug Design: Repurposing Techniques and Methodologies explores the application of computational tools that can be utilized for this approach. The book covers theoretical background and methodologies of chem-bioinformatic techniques and network modeling and discusses the various applied strategies to systematically retrieve, integrate and analyze datasets from diverse sources. Other topics include in silico drug design methods, computational workflows for drug repurposing, and network-based in silico screening for drug efficacy. With contributions from experts in the field and the inclusion of practical case studies, this book gives scientists, researchers and R&D professionals in the pharmaceutical industry valuable insights into drug design.

  • 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.

  • Basic Fundamentals of Drug Delivery

    • 1st Edition
    • English
    Basic Fundamentals of Drug Delivery covers 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 drug delivery system. The book also covers various approaches involved in optimizing the therapeutic performance of a biomolecule while designing its appropriate advanced formulation.

  • Pharmacology for Pharmacy Technicians

    • 3rd Edition
    • Kathy Moscou + 1 more
    • English
    Master key scientific principles to prepare for certification and practice as a Pharmacy Technician. Pharmacology for Pharmacy Technicians, 3rd Edition, is a comprehensive, yet approachable text written specifically for your needs and offering complete coverage of the principles of pharmacology and the way drugs work within the body’s systems. Concepts are supplemented throughout with patient scenarios, anatomy and physiology refreshers, drug monographs with pill photos, and a number of other learning aids to help you comprehend this subject matter. With its companion workbook, this learning package provides the essential foundation necessary to launch a successful and rewarding career in Pharmacy Technology!

  • Workbook for Pharmacology for Pharmacy Technicians

    • 3rd Edition
    • Kathy Moscou + 1 more
    • English
    Reinforce your comprehension of pharmacologic concepts with this hands-on workbook. Specially designed to parallel the material in Pharmacology for Pharmacy Technicians, 3rd Edition, this workbook provides in-depth study and review of the terminology, principles, and applications of pharmacology needed for certification and practice as a Pharmacy Technician. Its user-friendly format and engaging learning exercises include vocabulary quizzes, review questions, critical thinking exercises, research activities, and new case applications to help you build a solid foundation for pharmacy practice!

  • Side Effects of Drugs Annual

    A Worldwide Yearly Survey of New Data in Adverse Drug Reactions
    • 1st Edition
    • Volume 40
    • English
    Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Volume 40, first published in 1977, and continually published as a yearly update to the voluminous encyclopedia Meyler's Side Effects of Drugs, presents clinicians and medical investigators with a reliable and critical survey of new data and trends in the area of adverse drug reactions and interactions, with an international team of specialists contributing each year. Topics covered in this release include Central Nervous System Stimulants and Drugs that Suppress Appetite, Antidepressant drugs, Lithium, Drugs of abuse, Hypnotics and sedatives, Antipsychotic Drugs, and much more.

  • A Pharmacology Primer

    Techniques for More Effective and Strategic Drug Discovery
    • 5th Edition
    • Terry P. Kenakin
    • English
    A Pharmacology Primer: Techniques for More Effective and Strategic Drug Discovery, Fifth Edition features the latest ideas and research regarding the application of pharmacology to the process of drug discovery. Written by well-respected pharmacologist, Terry P. Kenakin, this primer is an indispensable resource for all those involved in drug discovery. This updated edition has been thoroughly revised to include material on quantifying drug efficacy through bias and cluster analysis, the impact of molecular dynamics and protein structural analysis, the real time kinetic analysis of drug effect, virtual screening for new drug chemical scaffolds, and much more. With full color illustrations and new examples throughout, this book remains a top reference for all industry and academic scientists that is also ideal for students directly involved in drug discovery or pharmacologic research.

  • 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.

  • Pharmacoepidemiology and Pharmacovigilance

    Synergistic Tools to Better Investigate Drug Safety
    • 1st Edition
    • Sabrina Nour + 1 more
    • English
    Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologi... studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologi... research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologi... concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations.

  • 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.

  • An Overview of FDA Regulated Products

    From Drugs and Cosmetics to Food and Tobacco
    • 1st Edition
    • Eunjoo Pacifici + 1 more
    • English
    Approx.270 pages

  • 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.

  • Diagnostic and Therapeutic Applications of Exosomes in Cancer

    • 1st Edition
    • Mansoor M. Amiji + 1 more
    • English
    Diagnostic and Therapeutic Applications of Exosomes in Cancer evaluates the potential of exosome content manipulation in the development of novel therapeutics. In recent years, exosomes, the small vesicles produced by all cell types, have been identified as contributors to cancer growth and metastasis. However, due to their unique biophysical properties, they are also being tested for use in therapeutic design and delivery, as well as in diagnostics. This book presents a comprehensive analysis on exosomes, with a main emphasis on their biogenesis and signaling, use as biomarkers, and as tools for imaging, drug delivery and the treatment of cancer.

  • Multivariate Analysis in the Pharmaceutical Industry

    • 1st Edition
    • Ana Patricia Ferreira + 2 more
    • English
    Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators.

  • Nanotechnology-Based Targeted Drug Delivery Systems for Brain Tumors

    • 1st Edition
    • Prashant Kesharwani + 1 more
    • English
    Nanotechnology-Based Targeted Drug Delivery Systems for Brain Tumors addresses brain anatomy and tumors and the progress and challenges in delivering drugs across the blood brain barrier. Several chapters are devoted to the latest technologies and advances in nanotechnology, along with practical solutions on how to design more effective nanocarriers for drug and gene delivery. This valuable resource prepares readers to develop novel drug delivery systems for the treatment of brain tumors that further promote the latest nanomedical technologies.

  • FDA's Drug Review Process and the Package Label

    Strategies for Writing Successful FDA Submissions
    • 1st Edition
    • Tom Brody
    • English
    FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label.

  • Inhaled Pharmaceutical Product Development Perspectives

    Challenges and Opportunities
    • 1st Edition
    • Anthony J. Hickey
    • English
    Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product. The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future.

  • Pharmaceutical Medicine and Translational Clinical Research

    • 1st Edition
    • Divya Vohora + 1 more
    • English
    Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource.

  • Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries

    Present Challenges and Future Solutions
    • 1st Edition
    • Mohamed Izham Mohamed Ibrahim + 2 more
    • English
    Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries: Present Challenges and Future Solutions examines the particularities of low- and middle-income countries and offers solutions based on their needs, culture and available resources. Drawing from the firsthand experience of researchers and practitioners working in these countries, this book addresses the socio-behavioral aspects of pharmacy and health, pharmacoeconomics, pharmaceutical policy, supply management and marketing, pharmacoepidemiology and public health pharmacy specific to low- and middle-income countries. While some practices may be applied appropriately in disparate places, too often pharmacy practice in low- and middle-income countries is directly copied from successes in developed countries, despite the unique needs and challenges low- and middle-income countries face.

  • Side Effects of Drugs Annual

    A Worldwide Yearly Survey of New Data in Adverse Drug Reactions
    • 1st Edition
    • Volume 39
    • English
    Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Volume 39 presents the latest on a variety of topics, with new chapters in this volume covering Central nervous system stimulants and drugs that suppress appetite, Antidepressant drugs, Lithium, Drugs of abuse, Hypnotics and sedatives, Antipsychotic Drugs, Antiepileptic Drugs, Opioid analgesics and narcotic antagonists, Anti-inflammatory and antipyretic analgesics and drugs used in gout, General anesthetics and therapeutic gases, Local anesthetics, Neuromuscular blocking agents and skeletal muscle relaxants, and more. First published in 1977, and continually published as a yearly update, this series provides clinicians and medical investigators with a reliable and critical survey of new data and trends in the area of adverse drug reactions and interactions, with an international team of specialists contributing their expertise each year.

  • An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology

    • 1st Edition
    • Padma Nambisan
    • English
    An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology provides a comprehensive look at the biggest technologies that have revolutionized biology since the early 20th century, also discussing their impact on society. The book focuses on issues related to bioethics, biosafety and intellectual property rights, and is written in an easy-to-understand manner for graduate students and early career researchers interested in the opportunities and challenges associated with advances in biotechnology. Important topics covered include the Human Genome Project, human cloning, rDNA technology, the 3Rs and animal welfare, bioterrorism, human rights and genetic discrimination, good laboratory practices, good manufacturing practices, the protection of biological material and much more. Full of relevant case studies, practical examples, weblinks and resources for further reading, this book offers an essential and holistic look at the ways in which biotechnology has affected our global society.

  • Conservation for the Anthropocene Ocean

    Interdisciplinary Science in Support of Nature and People
    • 1st Edition
    • Phillip S. Levin + 1 more
    • English
    Conservation for the Anthropocene Ocean: Interdisciplinary Science in Support of Nature and People emphasizes strategies to better connect the practice of marine conservation with the needs and priorities of a growing global human population. It conceptualizes nature and people as part of shared ecosystems, with interdisciplinary methodologies and science-based applications for coupled sustainability. A central challenge facing conservation is the development of practical means for addressing the interconnectedness of ecosystem health and human well-being, advancing the fundamental interdisciplinary science that underlies conservation practice, and implementing this science in decisions to manage, preserve, and restore ocean ecosystems. Though humans have intentionally and unintentionally reshaped their environments for thousands of years, the scale and scope of human influence upon the oceans in the Anthropocene is unprecedented. Ocean science has increased our knowledge of the threats and impacts to ecological integrity, yet the unique scale and scope of changes increases uncertainty about responses of dynamic socio-ecological systems. Thus, to understand and protect the biodiversity of the ocean and ameliorate the negative impacts of ocean change on people, it is critical to understand human beliefs, values, behaviors, and impacts. Conversely, on a human-dominated planet, it is impossible to understand and address human well-being and chart a course for sustainable use of the oceans without understanding the implications of environmental change for human societies that depend on marine ecosystems and resources. This work therefore presents a timely, needed, and interdisciplinary approach to the conservation of our oceans.

  • Profiles of Drug Substances, Excipients, and Related Methodology

    • 1st Edition
    • Volume 42
    • English
    Profiles of Drug Substances, Excipients, and Related Methodology, Volume 42 presents comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients, thus meeting the needs of the pharmaceutical community and allowing for the development of a timely vehicle for publishing review materials on the topic. This latest release covers a variety of substances, including Cinacalcet Hydrochloride, Clenbuterol Hydrochloride, Gliclazide, Lomefloxacin, Olmesartan, Propranolol, and Tolterodine Tartrate. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories, Physical profiles of drug substances and excipients, Analytical profiles of drug substances and excipients, Drug metabolism and pharmacokinetic profiles of drug substances and excipients, Methodology related to the characterization of drug substances and excipients, Methods of chemical synthesis, and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Nanostructures for Oral Medicine

    • 1st Edition
    • Ecaterina Andronescu + 1 more
    • English
    Nanostructures for Oral Medicine presents an up-to-date examination of the applications and effects of nanostructured materials in oral medicine, with each chapter addressing recent developments, specific applications, and uses of nanostructures in the oral administration of therapeutic agents in dentistry. The book also includes coverage of the biocompatibility of nanobiomaterials and their remarkable potential in improving human health and in reducing environmental pollution. Emerging advances, such as Dr. Franklin Tay's concept of a new nanotechnology process of growing extremely small, mineral-rich crystals and guiding them into the demineralized gaps between collagen fibers to prevent the aging and degradation of resin-dentin bonding is also discussed. This work will be of great value to those who work in oral medicine, providing them with a resource to gain a greater understanding of how nanotechnology can help them create more efficient, cost-effective products. In addition, it will be of great interest to those who work in materials science who wish to gain a greater appreciation of how nanostructured materials are applied in this field.

  • How to Optimize Fluid Bed Processing Technology

    Part of the Expertise in Pharmaceutical Process Technology Series
    • 1st Edition
    • Dilip Parikh
    • English
    How to Optimize Fluid Bed Processing Technology: Part of the Expertise in Pharmaceutical Process Technology Series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference. This book covers the theoretical concepts involved in fluidization, also providing a description of the choice and functionality of equipment. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale-up, troubleshooting, new development, safety, and process evaluation. Given its discussion of theoretical principles and practical solutions, this is a go-to resource for all those scientists and new researchers working with fluid bed granulation as a unit operation.

  • Nano- and Microscale Drug Delivery Systems

    Design and Fabrication
    • 1st Edition
    • Alexandru Mihai Grumezescu
    • English
    Nano- and Microscale Drug Delivery Systems: Design and Fabrication presents the developments that have taken place in recent years in the field of micro- and nanoscale drug delivery systems. Particular attention is assigned to the fabrication and design of drug delivery systems in order to i) reduce the side effects of therapeutic agents, ii) increase their pharmacological effect, and iii) improve aqueous solubility and chemical stability of different therapeutic agents. This book is designed to offer a cogent, concise overview of current scholarship in this important area of research through its focus on the characterization and fabrication of a variety of nanomaterials for drug delivery applications. It is an invaluable reference source for both biomaterials scientists and biomedical engineers who want to learn more about how nanomaterials are engineered and used in the design of drug delivery nanosystems.

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