Lists the necessary steps for meeting compliance requirements during the drug development process. Presents comprehensive approaches for validating analytical methods for pharmaceutical applications. Features key discussions on pre-approval inspections.

There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an additional layer of complexity. Testing Computers Systems for FDA/MHRA Compliance focuses on software module, software integration, hardware, and system acceptance testing. Reflecting the renewed emphasis of the FDA and other global regulatory agencies towards systematic inspections and risk-based validation with an underlying scientific rationale, this guide focuses on current best practices in computer systems testing in the regulatory environment. David Stokes demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. He includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11, and clarifies the relationship and responsibilities of the system "user" and "supplier". The author also delineates where testing starts in the project lifecycle, who performs what testing, where the lines of responsibility start and end, and the differences in the terminology used in the healthcare and general IT sectors. A checklist of questions to be used when developing System Test Specification(s), and templates for documenting typical system test results, round out the features that make this book a practical guide for all those involved in the development and implementation of IT systems for the pharmaceutical and related healthcare manufacturing industries. Senior managers, team project leaders, project team members, and industry trainees, will all benefit from this clear and practical guide.

Phytomedicine has become more important and gained constant improvement today for the betterment of health. Herbal medicine plays a significant role in the development of new drugs, contrary to the modern medicinal systems. For more than a decade, there has been a drastic improvement in phytomedicine across the world. This growth has reached a higher level in development by pharmaceutical industries everywhere. People have drifted toward herbal medication and practices for their food and health care. Therefore, in order to create abundant interest in the research of phytosciences, this book is one of the better reference tools. The bioactive compounds in plants need to be explored to know the scientific value and therapeutic properties of the medicinal plants against many diseases. This book contains chapters that are relevant to the advanced research in herbal medicines and will enlighten readers to the importance of medicinal plants as daily sources of nutrition and cures for diseases. This book highlights the unique features of the plants that have not been studied so far for their therapeutic potential. To prove the efficacy of medicinal plants, they have to be studied, examined, and scientifically verified. Hence, this book will better serve the researchers working under different aspects of phytomedicine. Features * The information provided through scientific validation is useful to study the pharmacological activity of herbals and their administration in the modern era. * The readers can find clear understanding in the research and development of phytopharmaceutical drugs. * The ideas incorporated in each chapter reveal the knowledge gained in studying the biological activities of the compounds present in the plant, which are indeed most worthy for the development of drugs. * The harvesting of new ideology toward modern scientific technologies that are employed in the field of pharmacological research.

Essential principles and practice of assay development

The first comprehensive, integrated treatment of the subject, Assay Development: Fundamentals and Practices covers the essentials and techniques involved in carrying out an assay project in either a biotechnology/drug discovery setting or a platform setting.

Rather than attempting comprehensive coverage of all assay development technologies, the book introduces the most widely used assay development technologies and illustrates the art of assay development through a few commonly encountered biological targets in assay development (e.g., proteases, kinases, ion channels, and G protein-coupled receptors). Just enough biological background for these biological targets is provided so that the reader can follow the logics of assay development. Chapters discuss:

The basics of assay development, including foundational concepts and applications

Commonly used instrumental methods for both biochemical assays and cell-based assays

Assay strategies for protein binding and enzymatic activity

Cell-based assays

High-throughput screening

An in-depth study of the now popular Caliper's off-chip kinase assay provides an instructive, real-world example of the assay development process.

Teaching can happen anywhere, at any time - not just in classrooms but in churches, in bookstores, in homes, anywhere people get together to share ideas that affect their daily life. In Teaching Community, bell hooks shows how complex ideas of cultural theory can be simplified and made relevant to the lives of working people, and how the values of shared knowledge and learning can be a catalyst for progressive social change. Teaching - so often undervalued in our society - can be a joyous and inclusive activity and, as hooks shows, can never be confined to the classroom.

Bioreactors: Animal Cell Culture Control for Bioprocess Engineering presents the design, fabrication, and control of a new type of bioreactor meant especially for animal cell line culture. The new bioreactor, called the "see-saw bioreactor," is ideal for the growth of cells with a sensitive membrane. The see-saw bioreactor derives its name from its principle of operation in which liquid columns in either limb of the reactor alternately go up and down. The working volume of the reactor is small, to within 15 L. However, it can easily be scaled up for large production in volume of cell mass in the drug and pharmaceutical industries. The authors describe the principle of operation of the see-saw bioreactor and how to automatically control the bioprocess. They discuss different control strategies as well as the thorough experimental research they conducted on this prototype bioreactor in which they applied a time delay control for yield maximization. To give you a complete understanding of the design and development of the see-saw bioreactor, the authors cover the mathematical model they use to describe the kinetics of fermentation, the genetic algorithms used for deriving the optimal time trajectories of the bioprocess variables, and the corresponding control inputs for maximizing the product yield. One chapter is devoted to the application of time delay control. Following a description of the bioreactor's working setup in the laboratory, the authors sum up their investigation and define the future scope of work in terms of design, control, and software sensors.

Extensively revised, with an updated title that reflects its expanded scope, International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products, Second Edition provides the practical labeling information you need to achieve rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, the book explains the relevant laws, regulations, and requirements in major markets worldwide. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, OTC products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more. This is not a "cookbook" of easy-to-follow recipes. It is a comprehensive resource that gives you the tools to stay ahead in the ever-changing regulatory environment.

Healing Plants of Nigeria: Ethnomedicine and Therapeutic Applications offers comprehensive information on the use of herbal medicines in West Africa. Combining an evidence-based, ethnobotanical perspective with a pharmacological and pharmaceutical approach to phytomedicine, the book bridges the gap between the study of herbal plants' pharmacological properties and active compounds for the development of clinical drugs and community-oriented approaches, emphasising local use. It demonstrates how the framework of African traditional medicine can be preserved in a contemporary clinical context. The book outlines the history and beliefs surrounding the traditional use of herbs by the local population alongside their application in contemporary phytotherapy in Nigeria and West Africa. It features a critical assessment of the scientific rationale behind the use of these plants in ethnomedicine and offers a composite catalogue of phytotherapeutic and wellness agents, detailing the safety profile, efficacy, and scientific integrity of plants used to treat diseases and optimise health. Features: An ethnobotanical survey containing over 200 full-colour photographs of Nigerian and West African plants. A unique combination of ethnobotany and pharmacognosy, bridging the divide between pharmaceutical and community-oriented approaches to herbal medicine research. Contextual discussion of the therapeutic potential of Nigerian herbal medicine. Offers a template which can be used to separate the superstitious aspects of ethnomedicine from culturally inherited deposits of knowledge. A handbook for herbal and natural medicine practitioners, the book is aimed at African thinkers, scientists, healthcare providers and students of pharmacology and ethnomedicine.

Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market.

Biomedical research is an intrinsically changing and evolving field. A more direct strategy for drug discovery has gradually replaced random screening of natural products. More rapid identification of key molecular structures for new drug candidates and characterization of biomolecules including proteins, polysaccharides, and nucleic acids are now possible. The ability to chemically modify cell surfaces and carbohydrate linkages has facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and more, Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition focuses on the latest developments in the science and regulation of bringing new drugs to market, including activities of the International Commission on Harmonization.

Extensively revised and updated, this second edition compares conventional and innovative drug delivery systems. The book covers significant ophthalmic advances and breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery. It examines procedures in pharmacokinetic/pharmacodynamic modeling for the determination of appropriate dosing regimens, covers new developments in animal modeling, and discusses current regulations governing patenting, commercial product release, and human testing. This in-depth reference lays the groundwork for overcoming constraints on the delivery of ophthalmic drugs.

Pharmaceutical Process Validation, Third Edition explores the roots of pharmaceutical process validation originating in Switzerland and Germany in the 1980s. It covers troubleshooting procedures, validation in contract manufacturing, and harmonization trends. New chapters include Validation for Medical Devices, Validation of Biotechnology Processes, Transdermal Process Validation, Integrated Packaging Validation, Statistical Methods for Uniformity and Dissolution Testing, Change Control and SUPAC, Validation in Contract Manufacturing, and Harmonization, GMPs, and Validation. It includes contributions by research and industry specialists from the U.S., Europe, and Japan.

In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond? Rapid Microbiological Methods in the Pharmaceutical Industry answers these questions and more. Martin Easter and his panel of experts: Describe the range of rapid microbiological methods and their applications, including practical tips, and their status regarding validation, established use, and regulatory acceptance Explore the origins of current methods and the current issues facing the requirements of microbiology and its associated test methods Delineate the challenges involved in seeking better and more pragmatic methods for the assessment of microbial hazards and risks to ensure product and consumer safety The book assists you in applying an effective system to assess the real microbiological hazards and, hence, quantify realistic risks. Additionally, it provides monitoring methods that will deliver meaningful, useful data for effective decision making in manufacturing, quality assurance, and product safety. The expert and authoritative information in Rapid Microbiological Methods in the Pharmaceutical Industry will help you find better solutions to ensuring the microbiological safety of pharmaceutical products. Features

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

This publication details the isolation of proteins from biological materials, techniques for solid-liquid separation, concentration, crystallization, chromatography, scale-up, process monitoring, product formulation, and regulatory and commercial considerations in protein production. The authors discuss the release of protein from a biological host, selectivity in affinity chromatography, precipitation of proteins (both non-specific and specific), extraction for rapid protein isolation, adsorption as an initial step for the capture of proteins, scale-up and commercial production of recombinant proteins, and process monitoring in downstream processing.

Pharmaceutical research draws on increasingly complex techniques to solve the challenges of drug design. Bringing together a number of the latest informatics techniques, this book looks at modelling and bioinformatic strategies; structural genomics and X-ray crystallography; virtual screening; lead optimisation; ADME profiling and vaccine design. A number of relevant case studies, focussing on techniques that have demonstrated their use, will concentrate on G-protein coupled receptors as potential disease targets. Providing details of state-of-the-art research, Drug Design: Cutting Edge Approaches will be invaluable to all drug discovery scientists, including medicinal and combinatorial chemists, molecular modellers, bio- and chemoinformaticians, and pharmacologists, amongst others. University and pharmaceutical company libraries will also benefit from having a copy on their shelves.

During the past decade, the importance of amorphous water-soluble substances has been increasingly recognised within the food and pharmaceutical industries. In response, Amorphous Food and Pharmaceutical Systems brings together current leading experts to contribute to this unique cross-disciplinary account of the subject. Coverage includes: water-compatible amorphous solids (physical, chemical behaviour), low water content systems (water as plasticizer); applications in food and pharmaceutical sciences and industries (processing and stability) along with state-of-the-art technology in food and pharmaceutical systems. This timely publication will be welcomed by academic and industrial researchers and professionals in the pharmaceuticals, food, materials and polymer sciences.

As our understanding of the science and functions of color in food has increased, the preferred colorants, forms of use, and legislation regulating their uses have also changed. Natural Colorants for Food and Nutraceutical Uses reflects the current tendency to use natural pigments. It details their science, technology, and applications as well as their nutraceutical properties.

Starting with the basics, the book creates an understanding of physical colors, discusses color measurement, and analyzes why natural pigments are preferred today. The authors present an overview of global colorants, including safety, toxicity and regulatory aspects. Information about inorganic and synthetic colorants is included. The book then focuses on applications of natural colorants, with special attention given to characteristics, extraction and processing stability, and the use of biotechnology and molecular biology to increase colorant production. Finally, the book examines the nutraceutical properties of natural colorants and compares them to other well-known nutraceutical components.

From the basics to highly specialized concepts and applications, Natural Colorants for Food and Nutraceutical Uses presents essential, practical information about pigments in the food industry. With its coverage of state-of-the-art technologies and future trends in the application of color to food, this book provides the most comprehensive, up-to-date survey of the field.

Biotechnology represents a novel and expanding international industry bound by new and ever-changing legislature. This text provides a comprehensive overview of product-specific, international and country-specific licensing requirements and general regulatory issues in biotechnology.

Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation practices. The book discusses how to clinical trial designs according to their probability for success, techniques to define distributions of virtual subjects' characteristics, methods to determine the sensitivity of the trial design, and the population relationship between dosing schedules and patient response.

This book introduces the principles and practices of modern medicinal chemistry and covers all aspects of drug discovery from the initial lead to final development. It teaches how to convert a lead compound into a potential drug and provides recent case histories as examples of successes. Medicinal Chemistry is unique in dealing with the subject in such a practical way and is the only book currently available to bring together all areas of the subject in one volume. This breadth of coverage is supplemented by references to specialist monographs and reviews, where the reader can find more detail on specific topics of interest if required. Medicinal Chemistry is essential reading for students studying medicinal chemistry, as it provides a grounding in all the required disciplines and subjects. It will also be of great interest to chemists, biochemists and pharmacologists either already working in or contemplating a career in the pharmaceutical and allied industries.

This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... -international regulation and deregulation -venture capitalist investment -the IND process -informed consent -changes in manufacturing and updated and extended coverage of... -pediatric drug trial design -the advantages and disadvantages of orphan drug designations -the maximization of package inserts for marketing -post approval safety surveillance -withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existing subspecialties in this field, Pharmacokinetics in Drug Discovery and Development details the different areas in the field providing the ideal comprehensive, quick access text and reference.

After an introduction of basic principles, the book is divided into sections that cover industrial and regulatory applications, clinical applications, and research applications. The following sections cover such topics as PK/PD approaches, clinical pharmacokinetic monitoring, population pharmacokinetics, linear systems approaches, and more. Fourteen authors, each an expert in his/her area of expertise, provide an extensive background into the subspeciality with emphasis on the section's theme. Covering the many sub-disciplines and providing pharmacokinetic concepts, terminology, and approaches, Pharmacokinetics in Drug Discovery and Development serves as a resource for professionals throughout this field.

This reference outlines important applications of statistics for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation in order to establish the safety and efficacy of pharmaceutical compounds. Reinforcing the role of good statistical practices (GSP) in drug research and formulation, Statistics in Drug Research is an essential source for biostatisticians; pharmacologists; clinical, industrial, and research pharmacists; statisticians and applied statisticians; biometricians; quality control personnel; drug regulatory personnel; and upper-level undergraduate and graduate students in these disciplines.

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.