Teaches proper procedures for using tools and analytical methods in a regulated lab setting
All regulated laboratories, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibration of instruments and validation of analytical methods. Following correct procedures ensures the generation of reliable data, which leads to the manufacture of safe and effective products.

Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions. Coverage includes: Method validation of potency, related substances, and dissolution testing Validation for pharmaceutical excipients, heavy metals, and bioanalysis Performance verification for common analytical instruments including HPLC, UV-Vis spectrophotometers, and pH meters The LCMS system calibration Proper environmental chamber qualification Entire qualification process for computer equipment, hardware, and software Validation of Excel spreadsheets Regulatory requirements of the FDA, ICH, Europe, and Japan

Full of practical tips on validation techniques and detailed discussions of instrument performance verification, this comprehensive guide represents a one-stop reference for remaining current in today's regulatory environment.

Analytical Method Validation and Instrument Performance Verification provides an invaluable working reference for laboratory managers, calibrationscientists, and research and development scientists.

When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshals seize products if a voluntary recall is not done. Drugs can be seized and medical devices can be detained and imports can be stopped at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought. Ensuring that your company is in compliance at all times in all departments is a never-ending task. Failure to get it right, even once, can mean excessive fines, penalties, or possible debarment. The FDA Administrative Enforcement Manual explores the control of drug research in pharmaceutical, vaccine, biologic, biotechnology, medical device, and cosmeceutical industries. Introducing basic industry techniques, the author explores every day industry problems and presents suggested methods for applying the theory to resolve them. The book covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more. It supplements these topics with regulations, lawsuit case studies, enforcement information, and reference materials. Offering insight into the impact of FDA enforcement on the national and international pharmaceutical industry, practitioners and industry suppliers, the book provides an understanding of drug development and manufacturing regulations in the United States and shows you what it takes to keep your company in compliance. The only complete, single source available, the FDA Administrative Enforcement Manual draws on the author's experience in the trenches of the pharmaceutical industry with administrative enforcement activities.

Although there are numerous books on drug metabolism, Radiotracers in Drug Development is unique in explaining how radiotracers are used to elucidate a drug's absorption, distribution, metabolism, and excretion (ADME). Covering traditional and recent technologies and applications, the book takes a strong industrial approach, discussing the basics of scintillation counting and untangling the various data processing methods often specific to individual manufacturers. The chapters include descriptions of the latest micro-plate counters and the growing applications of accelerator mass spectrometry, positron emission tomography, gamma-scintigraphy, and radioluminography. In addition to describing how the analytical technologies work, the contributors explain how the data are interpreted and used in the drug registration process. A unique reference and training aid essential for every drug metabolism department or drug metabolism research team, the book provides insight into the use and practice of ADME in a way that is both instructive and practical. Moving easily across the boundaries of biology, chemistry, and physics, this is the only comprehensive, interdisciplinary resource covering the how-tos of employing radiotracers in drug development. It provides detailed information on how the science is relevant to the registration process.

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

This reference studies the most recent advances in the development of ocular drug delivery systems. Covering methods to treat or prevent ocular inflammation, retinal vascular disease, retinal degeneration, and proliferative eye disease, this source covers breakthroughs in the management of endophthalmitis, uveitis, diabetic macular edema, and age-related macular degeneration.

This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,734 medicinal plants, collected from 5,507 books/articles published in Chinese and international journals. A chemical structure with stereo-chemistry bonds is provided for each chemical component, in addition to conventional information, such as Chinese and English names, physical and chemical properties. It includes a name list of medicinal plants from which the chemical component was isolated. Furthermore, abundant pharmacological data for nearly 8,000 chemical components are presented, including experimental method, experimental animal, cell type, quantitative data, as well as control compound data. The seven indexes allow for complete cross-indexing. Regardless whether one searches for the molecular formula of a compound, the pharmacological activity of a compound, or the English name of a plant, the information in the book can be retrieved in multiple ways.

Analytical ultracentrifugation is one of the most powerful solution techniques for the study of macromolecular interactions, to define the number and stoichiometry of complexes formed, and to measure affinities ranging from very strong to very weak and repulsive. Building on the data analysis tools described in the volume Sedimentation Velocity Analytical Ultracentrifugation: Discrete Species and Size-Distributions of Macromolecules and Particles, and the experimental and instrumental aspects in the first volume Basic Principles of Analytical Ultracentrifugation, the present volume Sedimentation Velocity Analytical Ultracentrifugation: Interacting Systems is devoted to the theory and practical data analysis of dynamically coupled sedimentation processes. This volume is designed to fill a gap in biophysical methodology to provide a framework that builds on the fundamentals of the highly developed traditional methods of analytical ultracentrifugation, updated with current methodology and from a viewpoint of modern applications. It will be an invaluable resource for researchers and graduate students interested in the application of analytical ultracentrifugation in the study of interacting systems, such as biological macromolecules, multi-protein complexes, polymers, or nanoparticles.

Ibuprofen is widely used throughout the world for a variety of conditions. This reference work provides a comprehensive and critical review of the basic science and clinical aspects of the drug. The book begins with the history and development of the drug and its current patterns of use world- wide before moving on to examine its basic pharmaceutical attributes and medicinal chemistry. The properties of various formulations are described (oral prescription and OTC, topical and others) are described. The pharmacokinetics of ibuprofen in animals and humans is discussed - highlighting the factors affecting absorption, distribution, metabolism and elimination. The clinical pharmacology and toxicology and the drug's mechanisms of action in different disease states and conditions are covered. The therapeutic uses in various acute and inflammatory conditions is detailed. Also considered are the safety versus efficacy issues and the pharmacoepidemiological data.

Specialists drawn from industry, agency and academia explain the role of the various elements in the marketing communications process, and show how a reassessment of the marketing mix can result in a positive response to challenges imposed by a changing commercial environment.

Given novel infectious diseases such as COVID-19 and antibiotic resistance new antimicrobial discovery is an important research area. Considering that nature is a vast source of bioactive molecules with antimicrobial activity, the main aim of this book is to present a comprehensive outlook of current research in the field of natural antimicrobials. It discusses the antimicrobial activity of medicinal plants, beehives, and mushrooms with a global coverage of antimicrobial agents from rich forests of Brazil (Amazon), North-Eastern forests of Peru, Argentina, Colombia, India, Bangladesh, Nepal, Middle East, Turkey, Croatia, Greece, Germany and Russia. The book covers the results of the in vitro screening of antimicrobial activities of extracts and isolated compounds from natural origins. It is divided into three sections: i) Section I, includes natural antimicrobials from plants; ii) Section II incorporates antimicrobial agents/secondary metabolites from plants, and (iii) Section III focuses on antimicrobials from mushrooms, beehive and delivery systems for different types of antimicrobials. Promising Antimicrobials From Natural Products is immensely useful for post graduate students, researchers in plant science, microbiology, biotechnology, pharmacology, pharma companies and those who are interested in herbal, eco-friendly, cost-effective and sustainable antimicrobials

This guide contains over 20,000 entries completely cross-indexed and quoted in context to provide readers with instant access to every noun, phrase, and concept used by the Drug Enforcement Administration and U.S. Food and Drug Administration.

This book aims to set out the political, social, legal and scientific underpinning of risk assessment and risk management for toxic substances. It describes the principles and processes the practitioners undertake when looking at the regulatory risk implications of their work.

The broad range of G protein-coupled receptors (GPCRs) encompasses all areas of modern medicine and have an enormous impact on the process of drug development. Using disease-oriented methods to cover everything from screening to expression and crystallization, G Protein-Coupled Receptors in Drug Discovery describes the physiological roles of GPCRs and their involvement in various human diseases. The book presents current approaches in drug discovery that include target selection, establishment of screening and functional assays. It also covers recombinant GPCR expression for drug screening and structural biology, different methods for structural characterization of GPCRs, and the importance of bioinformatics. The book has been carefully edited to avoid overlapping information, some duplication has been intentionally permitted so that each chapter can function as an independent unit. Providing in-depth discussions on structure and dynamics of GPCRs, this book outlines the importance of the GPCRs to drug discovery in general and drug targets specifically. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.

This book is an accessible resource offering practical information not found in more database-oriented resources. The first chapter lists acronyms with definitions, and a glossary of terms and subjects used in biochemistry, molecular biology, biotechnology, proteomics, genomics, and systems biology. There follows chapters on chemicals employed in biochemistry and molecular biology, complete with properties and structure drawings. Researchers will find this book to be a valuable tool that will save them time, as well as provide essential links to the roots of their science. Key selling features: Contains an extensive list of commonly used acronyms with definitions Offers a highly readable glossary for systems and techniques Provides comprehensive information for the validation of biotechnology assays and manufacturing processes Includes a list of Log P values, water solubility, and molecular weight for selected chemicals Gives a detailed listing of protease inhibitors and cocktails, as well as a list of buffers

Originally published in 1999 The Commercial Use of Biodiversity examines how biodiversity and the genetic material it contains are now as valuable resources. Access to genetic resources and their commercial development involve a wide range of parties such as conservation and research institutes, local communities, government agencies and companies. Equitable partnerships are not only crucial to conservation and economic development but are also in the interests of business and often required by law. In this authoritative and comprehensive volume, the authors explain the provisions of the Convention on Biological Diversity on access and benefit-sharing, the effect of national laws to implement these, and aspects of typical contracts for the transfer of materials. They provide a unique sector-by-sector analysis of how genetic resources are used, the scientific, technological and regulatory trends and the different markets in Pharmaceuticals, Botanical Medicines, Crop Development, Horticulture, Crop Protection, Biotechnology (in fields other than healthcare and agriculture) and Personal Care and Cosmetics Products. This will be an essential sourcebook for all those in the commercial chain, from raw material collection to product discovery, development and marketing, for governments and policy-makers drafting laws on access and for all the institutions, communities and individuals involved in the conservation, use, study and commercialisation of genetic resources.

From the laboratory to full-scale commercial production, this reference provides a clear and in-depth analysis of bioreactor design and operation and encompasses critical aspects of the biocatalytic manufacturing process. It clarifies principles in reaction and biochemical engineering, synthetic and biotransformation chemistry, and biocell and enzyme kinetics for successful applications of biocatalysis and bioprocess technologies in the food, chiral drug, vitamin, pharmaceutical, and animal feed industries. Studying reactions from small to supramolecules, this reference provides an abundant supply of end-of-chapter problems to sharpen understanding of key concepts presented in the text.

This volume includes information on recent advances in five important areas: an account of inhibitors of the caspase family of proteolytic enzymes that represent a new class of anti-inflammatory and antiapoptotic agents of potential value in rheumatoid arthritis; and a survey of semi-synthetic and totally synthetic antibiotics and anti-HIV agents and their sites of interaction; the development of inhibitors of the intracellular enzyme acyl-CoA: cholesterol O-acyltransferase (ACAT) for the treatment of hypercholesterolemia; a description of recent progress in growth hormone secretagogues, with the focus on strategies to improve oral bioavailability and duration of action; and information on inhibition of the proteolytic enzyme, hepatitis C protease N-3(NS3), (required for vital replication) as one of the most attractive targets for HCV infections.

Discussing a comprehensive range of topics, Advanced Pharmaceutics: Physicochemical Principles reviews all aspects of physical pharmacy. The book explains the basic, mechanistic, and quantitative interpretation skills needed to solve physical pharmacy related problems. The author supplies a strong fundamental background and extensively covers thermodynamics, ionic equilibria, solutions and distribution, surface chemistry and colloids, kinetics, diffusion, and polymer science. He outlines the latest research on diffusion through a membrane and the use of polymers in dosage forms. Packed with formulae and models, the book demonstrates the development of each and then describes the use of those models for a variety of formulation situations. The author's detailed explanation of the evolution of the formulae provides a clear understanding of when and how they are used. This bottom-up approach delineates the evolution of the formulae and gives a clear understanding of when and how they should be used. The book provides an in-depth review and analysis of dosage form design criteria that you can rapidly implement in your day-to-day work.

Applied Biophysics for Drug Discovery is a guide to new techniques and approaches to identifying and characterizing small molecules in early drug discovery. Biophysical methods are reasserting their utility in drug discovery and through a combination of the rise of fragment-based drug discovery and an increased focus on more nuanced characterisation of small molecule binding, these methods are playing an increasing role in discovery campaigns. This text emphasizes practical considerations for selecting and deploying core biophysical method, including but not limited to ITC, SPR, and both ligand-detected and protein-detected NMR. Topics covered include: Design considerations in biophysical-based lead screening Thermodynamic characterization of protein-compound interactions Characterizing targets and screening reagents with HDX-MS Microscale thermophoresis methods (MST) Screening with Weak Affinity Chromatography Methods to assess compound residence time 1D-NMR methods for hit identification Protein-based NMR methods for SAR development Industry case studies integrating multiple biophysical methods This text is ideal for academic investigators and industry scientists planning hit characterization campaigns or designing and optimizing screening strategies.

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

While change control can ensure that developments do not compromise business operations, when dealing with pharmaceuticals manufacturing, change control must also ensure that developments do not compromise regulatory compliance. Pharmaceutical Engineering Change Control, Second Edition gives you the technical and management skills required to successfully and efficiently employ change control procedures.

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.