Skip to main content
Elsevier

Books in Pharmaceutical science

  • 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.

  • 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.

  • 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.

  • Nanotechnology-Based Approaches for Targeting and Delivery of Drugs and Genes

    • 1st Edition
    • Vijay Mishra + 3 more
    • English
    Nanotechnology-Based Approaches for Targeting and Delivery of Drugs and Genes provides an overview of the important aspects of nanomedicine in order to illustrate how to design and develop novel and effective drug delivery systems using nanotechnology. The book is organized into three sections, beginning with an introduction to nanomedicine and its associated issues. Section two discusses the latest technologies in nanomedicine, while the third section covers future developments and challenges in the field. By focusing on the design, synthesis, and application of a variety of nanocarriers in drug and gene delivery, this book provides pharmaceutical and materials science students, professors, clinical researchers, and industry scientists with a valuable resource aimed at tackling the challenges of delivering drugs and genes in a more targeted manner.

  • 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.

  • 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.

  • Vascular Pharmacology

    Smooth Muscle
    • 1st Edition
    • Volume 78
    • English
    Vascular Pharmacology: Smooth Muscle provides up-to-date information on the structure, function, signaling, and development of vascular smooth muscle. Contributors include prominent scientists and highly-recognized experts with major accomplishments in the field of vascular smooth muscle research.

  • Managing the Drug Discovery Process

    How to Make It More Efficient and Cost-Effective
    • 1st Edition
    • Susan Miller + 3 more
    • English
    Managing the Drug Discovery Process: How to Make It More Efficient and Cost-Effective thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers, and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological, and infrastructural. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process. This book takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Written in an engaging manner and including memorable insights, this book is aimed at redirecting the drug discovery process to make it more efficient and cost-effective in order to achieve the goal of saving countless more lives through science. A valuable and compelling resource, this is a must-read for all students and researchers in academia and the pharmaceutical industry.

  • How to Validate a Pharmaceutical Process

    • 1st Edition
    • Steven Ostrove
    • English
    How to Validate a Pharmaceutical Process provides a “how to” approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why” is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation.

  • Nanobiomaterials in Dentistry

    Applications of Nanobiomaterials
    • 1st Edition
    • Alexandru Grumezescu
    • English
    Nanobiomaterials in Dentistry: Applications of Nanobiomaterials discusses synthesis methods and novel technologies involving nanostructured bio-active materials with applications in dentistry. This book provides current research results for those working in an applied setting. The advantage of having all this information in one coherent text will be the focused nature of the chapters and the ease of which this information can be accessed. This collection of titles brings together many of the novel applications these materials have in biology and discusses the advantages and disadvantages of each application and the perspectives of the technologies based on these findings. At the moment there is no other comparable book series covering all the subjects approached in this set of titles.

  • Pharmacy Practice in Developing Countries

    Achievements and Challenges
    • 1st Edition
    • Ahmed Fathelrahman + 2 more
    • English
    Pharmacy Practice in Developing Countries: Achievements and Challenges offers a detailed review of the history and development of pharmacy practice in developing countries across Africa, Asia, and South America. Pharmacy practice varies substantially from country to country due to variations in needs and expectations, culture, challenges, policy, regulations, available resources, and other factors. This book focuses on each country’s strengths and achievements, as well as areas of weakness, barriers to improvement and challenges. It sets out to establish a baseline for best practices, taking all of these factors into account and offering solutions and opportunities for the future. This book is a valuable resource for academics, researchers, practicing pharmacists, policy makers, and students involved in pharmacy practice worldwide as it provides lessons learned on a global scale and seeks to advance the pharmacy profession.

  • Social Aspects of Drug Discovery, Development and Commercialization

    • 1st Edition
    • Odilia Osakwe + 1 more
    • English
    Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society. This book examines the scientific, legal, philosophical, economic, political, ethical and cultural factors that contribute to drug development. The pharmaceutical industry is under scrutiny to develop safer and more effective drugs in a quicker and more affordable manner. Recent criticism and debates have emphasized varying opinions on the issues concerning the drug discovery and development process. This book provides thoughtful and valuable discussions and analysis of the social challenges and potential opportunities through all stages of the pharmaceutical process, from inception through marketing. With a unique focus on the social factors that increasingly play a role in how drug development is planned, structured, and executed throughout the drug product lifecycle, this is an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society.

  • Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

    • 1st Edition
    • Carrie Markgraf + 2 more
    • English
    Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability.

  • Principles of Translational Science in Medicine

    From Bench to Bedside
    • 2nd Edition
    • Martin Wehling
    • English
    Principles of Translational Science in Medicine: From Bench to Bedside, Second 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 numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine.

  • The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

    • 1st Edition
    • Joerg Bluemel + 3 more
    • English
    The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area.

  • Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies

    • 1st Edition
    • Manmohan Singh + 1 more
    • English
    Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel approaches to the treatment of cancer, immunotherapy and more. It includes real-world cases and examples which highlight formulations with therapeutic proteins, monoclonal antibodies, peptides and biobetters, as well as cases on novel vaccines formulations including evolving pathogens, novel modalities of vaccines, universal vaccines. This book is a thorough and useful resource on the development of novel biologics, vaccines and cancer therapies.

  • Handbook of Cosmeceutical Excipients and their Safeties

    • 1st Edition
    • K Y Heng + 5 more
    • English
    Cosmeceuticals are the latest additions to the health industry and have an ever-expanding market. They are considered to be a marriage between cosmetics and drugs and are defined as preparations applied on the body that may modify the physiological functions of the skin. However, as more cosmeceuticals are being launched in the market and more types of drugs are incorporated into the formulation, the composition of cosmeceuticals is becoming more complex. Handbook of Cosmeceutical Excipients and their Safeties summarises the current evidence relating to cosmeceuticals’ side effects and highlights the important information that practitioners and consumers need to know, as well as ways to avoid the adverse effects of the excipients. Handbook of Cosmeceutical Excipients and their Safeties includes chapters covering topics such as the history of cosmeceuticals and the laws that regulate them, skin permeation, carcinogenicity as a systemic adverse effect and dermatitis as a topical adverse effect. It concludes with an appendix that gives brief information on the potency and permeability of common ingredients in cosmeceuticals. The appendix aims to highlight the maximum allowable quantity of each ingredient to ensure product safety for consumers. The appendix was prepared by compiling the ingredients of 257 products containing more than 500 compounds, collected from a hospital pharmacy in Singapore.

  • Colloid and Interface Science in Pharmaceutical Research and Development

    • 1st Edition
    • Hiroyuki Ohshima + 1 more
    • English
    Colloid and Interface Science in Pharmaceutical Research and Development describes the role of colloid and surface chemistry in the pharmaceutical sciences. It gives a detailed account of colloid theory, and explains physicochemical properties of the colloidal-pharmaceut... systems, and the methods for their measurement. The book starts with fundamentals in Part I, covering fundamental aspects of colloid and interface sciences as applied to pharmaceutical sciences and thus should be suitable for teaching. Parts II and III treat applications and measurements, and they explains the application of these properties and their influence and use for the development of new drugs.

  • Alkyl Polyglucosides

    From Natural-origin Surfactants to Prospective Delivery Systems
    • 1st Edition
    • Ivana Pantelic
    • English
    The on-going ‘green’ trend in the personal care industry coupled with global environmental concerns, place natural-origin, biodegradable and skin-friendly surfactants such as alkyl polyglucosides (APGs) in high demand. After successful use in cosmetics, sufficient data has been obtained to welcome some sugar emulsifiers into the field of drug dosage. Alkyl Polyglucosides presents a comprehensive compendium which guides a researcher from the APG-related preformulation stages to formulation processing, including the investigation of various APG-stabilized systems skin performance. This book introduces various APG representatives, their benefits in relation to certain conventional surfactants, physicochemical and interfacial properties, possible interaction with commonly used ingredients and diverse characterization techniques indispensable for the assessment of colloidal systems. The first chapter introduces alkyl polyglucosides, followed by chapters on their properties, behaviour, an overview of the patent protection mechanisms and guidelines for submitting patent applications. Finally, a conclusion surveys international patent applications involving APGs.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 39
    • Harry G. Brittain
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. 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.

  • Predictive Modeling of Pharmaceutical Unit Operations

    • 1st Edition
    • Preetanshu Pandey + 1 more
    • English
    The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Qualityby Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included.

  • International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

    A Global Perspective
    • 1st Edition
    • Pierre-Louis Lezotre
    • English
    International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health.

  • Pharma's Prescription

    How the Right Technology Can Save the Pharmaceutical Business
    • 1st Edition
    • Kamal Biswas
    • English
    The pharmaceutical industry needs a shot in the arm – and not a moment too soon. The executive suite is mired in a bygone era, a time when extensive, well-funded pharmaceutical R&D produced blockbuster drugs, kept everything in-house and reaped the financial rewards. But that way of working needs to change. Executives now need to know what the technologists in their companies are doing in order to survive the next decade. Written for those new to industry, as well as for experienced professionals or specialists looking to expand their knowledge, this book is a must-read for business executives and information technologists alike. Pharma’s Prescription bridges the knowledge gap between current business practices and the most valuable technologies today. This book is filled with practical, real-life examples from industry and is a straightforward guide for all pharmaceutical and information technology executives who need to improve their businesses.

  • Formulation Tools for Pharmaceutical Development

    • 1st Edition
    • J E Aguilar
    • English
    A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools.Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software.

  • The Path from Biomarker Discovery to Regulatory Qualification

    • 1st Edition
    • Federico Goodsaid + 1 more
    • English
    The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book—it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/C...

  • The Future of Drug Discovery

    Who Decides Which Diseases to Treat?
    • 1st Edition
    • Tamas Bartfai + 1 more
    • English
    The Future of Drug Discovery: Who decides which diseases to treat? provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, such as Alzheimer’s disease, untreatable pain, antibiotics and more. This book carefully exposes the gap between the medicines and therapies we need and the current business path. By analyzing the situation and discussing prospects for the next decade, the The Future of Drug Discovery is a timely book for all those who care about the development needs for drugs for disease.

  • Profiles of Drug Substances, Excipients, and Related Methodology

    • 1st Edition
    • Volume 38
    • Harry G. Brittain
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. 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.

  • Lead Compounds from Medicinal Plants for the Treatment of Cancer

    • 1st Edition
    • Christophe Wiart
    • English
    Lead Compounds from Medicinal Plants for the Treatment of Cancer is the first volume in the series, Pharmaceutical Leads from Medicinal Plants. The plant species described in this reference have been carefully selected based on pharmacological evidence and represent today’s most promising sources of natural products for the discovery of anti-cancer drugs. Containing references to primary source material, over a hundred botanical illustrations, a table of chemical structures and much more, this book is an essential starting point for cancer researchers and those involved in anti-cancer drug discovery helping you identify the best novel lead molecules for further anti-cancer drug development.

  • A Comprehensive Guide to Toxicology in Preclinical Drug Development

    • 1st Edition
    • Ali S. Faqi
    • English
    A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 37
    • Harry G. Brittain
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. 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.

  • Clinical Trials

    Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
    • 1st Edition
    • Tom Brody
    • English
    Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.

  • An Introduction to Pharmaceutical Sciences

    Production, Chemistry, Techniques and Technology
    • 1st Edition
    • Jiben Roy
    • English
    This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry.A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 36
    • Harry G. Brittain
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. 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.

  • Outsourcing Biopharma R&D to India

    • 1st Edition
    • P R Chowdhury
    • English
    The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 35
    • Harry G. Brittain
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. 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.

  • Contemporary Aspects of Biomedical Research

    Drug Discovery
    • 1st Edition
    • Volume 57
    • English
    Each volume of Advances in Pharmacology provides a rich collection of reviews on timely topics. Emphasis is placed on the molecular basis of drug action, both applied and experimental.

  • Developing Solid Oral Dosage Forms

    Pharmaceutical Theory and Practice
    • 1st Edition
    • Yihong Qiu + 4 more
    • English
    Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development

  • Medicinal Chemistry of Anticancer Drugs

    • 1st Edition
    • Carmen Avendaño + 1 more
    • English
    Antitumor chemotherapy is nowadays a very active field of research, and a huge amount of information on the topic is generated every year. Although many books are available that deal with clinical aspects of cancer chemotherapy, this book addresses the need for an updated treatment from the point of view of medicinal chemistry and drug design. The focus of Medicinal Chemistry of Anticancer Drugs is on the mechanism of action of antitumor drugs from the molecular point of view and on the relationship between chemical structure and chemical and biochemical reactivity of antitumor agents, aiming at the rationalization of the action of this type of drug, which would allow the design of new active structures.

  • Elsevier's Dictionary of Vitamins and Pharmacochemistry

    • 1st Edition
    • Henry Philippsborn
    • English
    The dictionary will contain terms covering the following fields and subfields: Vitamin Technology: Vitamin biochemistry / Physiology; Origin of vitamins: natural, synthetic; Fat-soluble vitamins; Water-soluble vitamins; Vitamins as antioxidants; Vitamin deficiencies / Hypervitaminosis - Enzymes/Proteins: Biotechnology as applied biological science aimed at industrial exploitation - Hormones: Biochemistry; Physiology - Pharmaceutical Chemistry / Pharmaceutical Technology / Pharmaceutical Processes: Conception of the active principles; Structural analysis; Antibiotics and their way of action; Biochemistry; The Drug / The Medicament: Definition, origin, way of action; Biochemistry - Medical Aspects in the languages English, German, French and Portuguese.

  • Drug Discovery

    From Bedside to Wall Street
    • 1st Edition
    • Tamas Bartfai + 1 more
    • English
    Everyone expects something from the drug industry. Physicians and patients, investors, regulators and administrators all have an active interest. Everyone wants to know what makes drugs ‘work’ medically and economically. Why are drugs so expensive? Is it the drug companies or investors who demand high profits? What governs the pharmacoeconomics? Why are so few diseases treatable? Drug Discovery opens the windows and doors of the industry telling the story of drug development by using real stories from inside the process.

  • The Law and Ethics of the Pharmaceutical Industry

    • 1st Edition
    • M.N.G. Dukes
    • English
    As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation.Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change.

  • Ethnomedicine and Drug Discovery

    • 1st Edition
    • Volume 1
    • M.M. Iwu + 1 more
    • English
    The emergence of new infectious, chronic and drug resistant diseases have prompted scientists to look towards medicinal plants as agents for treatment and prevention. This book provides an interphase between ethnomedical and ethnobotanical approaches to new drug discovery and advances in biotechnology and molecular science that has made it increasingly feasible to transform traditional medicines into modern drugs. These novel approaches also raise new issues and the volume explores economic, ethical and policy considerations of drug development based on indigenous knowledge or traditional medicine.This work also features standardization and development of phytomedicines for major therapeutic indications, including emerging infectious diseases affecting developing and developed countries.The publication provides state-of-the-art information on the most innovative science, the research, the industry, the market, and the future of ethnomedicine and drug discovery.

  • Controlled Release Veterinary Drug Delivery

    Biological and Pharmaceutical Considerations
    • 1st Edition
    • Michael J. Rathbone + 1 more
    • English
    Many controlled release veterinary drug delivery systems (CRVDDS) are presently in use, and recently there has been a host of new CRVDDS within veterinary medicine. The challenges of this area of drug delivery arise from the unique anatomy and physiology of the target animal, the cost constraints associated with the value of the animal being treated and the extended periods of time that delivery must be sustained for (often measured in months).The purpose of this book is to introduce the reader to the unique opportunities and challenges of the field of CRVDDS and to explain and discuss the basic controlled release principles underlying the development of CRVDDS. Its aim is to provide an overview of many of the areas where CRVVDS have application, and to highlight the opportunities and prospects for controlled release technology in the veterinary field.Controlled Release Veterinary Drug Delivery comprises chapters that provide workers in the field (and those interested in this area) with information on the design, development and assessment of a variety of CRVDDS. The book contains chapters that describe the relevant animal physiological and anatomical considerations alongside descriptions of current and emerging controlled release delivery systems for a variety of routes for drug delivery, and present overviews on the physical and chemical assessment of veterinary controlled release delivery systems.The veterinary area is abound with opportunities for the development of controlled release drug delivery technologies. It is an area of medicine that is open to the acceptance of novel drug delivery devices, and which readily encompasses the use of novel routes of administration. It is an area of many unmet needs, most of which offer opportunities and unique challenges for the innovative formulation scientist to provide solutions. This book will provide an insight into the biological, clinical and pharmaceutical challenges that face the formulation scientist in this interesting and diverse area of research.

  • The Many Faces of RNA

    • 1st Edition
    • D. S. Eggleston + 2 more
    • English
    The Many Faces of RNA is the subject for the eighth SmithKline Beecham Pharmaceuticals Research Symposia. It highlights a rapidly developing area of scientific investigation. The style and format are deliberately designed to promote in-depth presentations and discussions and to facilitate the forging of collaborations between academic and industrial partners.This symposium focuses on several of the many fundamental, advancing strategies for exploring RNA and its functions. It emphasizes the interplay between biology, chemistry, genomics, and molecular biology which is leading to exciting new insights and avenues of investigation. The book explores RNA as a therapeutic target, RNA as a tool, RNA and its interactions, along with chemical, computational, and structural investigations.

  • Peptides

    Synthesis, Structures, and Applications
    • 1st Edition
    • Bernd Gutte
    • English
    In recent years, research has shown the importance of peptides in neuroscience, immunology, and cell biology. Active research programs worldwide are now engaged in developing peptide-based drugs and vaccines using modification of natural peptides and proteins, design of artificial peptides and peptide mimetics, and screening of peptide and phage libraries. In this comprehensive book, the authors discuss peptide synthesis and application within the context of their increasing importance to the pharmaceutical industry. Peptides: Synthesis, Structures, and Applications explores the broad growth of information in modern peptide synthetic methods and the structure-activity relationships of synthetic polypeptides.

  • Advances in Drug Research

    • 1st Edition
    • Volume 26
    • English
    Volume 26 continues the trend of shorter, more frequent volumes. With Volume 25, the series gained a new co-editor, Urs Meyer. While retaining the commitment to publish chapters on therapeutic or chemical classes and on general topics or concepts, the series' coverage has expanded to include methodological chapters, and new areas of recognized or potential significance to drug research, especially in molecular pharmacology.