Bringing together nearly forty collaborators from academic and industrial laboratories, this reference furnishes an overview of the subject from a historical, kinetic, and chemical context. A source of expertise for a rapidly changing and expanding field, the book provides a framework for drug metabolism in drug discovery and development. Containing tables, drawings, photographs, and equations, it highlights the importance of pharmacokinetics and cytochrome P450, explains clearance, volume of distribution, sequential metabolism, and nonlinear kinetics, summarizes concepts of Phase 1 and 2 metabolites, evaluates tertiary amine metabolism and reactive metabolite chemistry, and more.

"Cannabis sativa" has been a source of man-mad products for over 5000 years. This book contains a series of dissertations, supported by over 700 references, on the history, ethnobotany, chemistry and analysis, and cultivation and processing of cannabis. The medicinal and non-medicinal uses of the plant and its derivates are viewed in the context of national and international legislation to define and control its use. Developments in cannabinoid pharmacology research and receptor theory are also discussed.

This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing.
Explains how the Food and Drug Administration's latest Good Manufacturing Process guidelines supporting electronic identification and electronic signatures for batch record registration together with computer system technologies will influence pharmaceutical production automation
Designed to provide quick and easy access to a whole range of system development topics, Automation and Validation of Information in Pharmaceutical Processing
defines a complete life-cycle methodology that integrates equipment, people, and information
presents concepts, guidelines, test plans, example forms, and application details for previously unavailable computer system validation of complex automated information systems
introduces, for the first time in depth, PQ testing of integrated manufacturing execution (MES) and manufacturing resource planning (MRP) applications
describes how human resource programs maximize productivity gains for automation initiatives
discusses approaches to automating batch operations with process control systems using industry examples and applicable computer technology concepts
provides an outline for IQ, OQ, and PQ test plans for process control systems, including forms for use in testing instrumentation and distributed control system installation and operations
employs a business analysis standpoint on life-cycle planning to justify new automation projects, including multiyear drug manufacturing plans
documents the successful application of life-cycle methodologies to supply chain functions
and much more
Together with references, tables, and drawings, Automation and Validation of Information in Pharmaceutical Processing is an essential, hands-on resource for pharmaceutical scientists, manufacturers, and engineers; drug quality assurance and regulatory personnel; project and program manufacturers; information system professionals and software developers and analysts; information technology practitioners; and graduate-level and continuing-education students in these disciplines.

Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these principles can be bonded with quality assurance, enabling you to build the highest quality into your products. Beginning with definitions of validation, the authors guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. Packed with tools to help you follow the logic of the validation process, the book covers testing, certification, protocols, final reports, sign-offs, ways to create seamless audit trails, and other topics impacting the qualification of a system, equipment, and/or process.

Employing a wide range of examples from G-protein-coupled receptors and ligand-gated ion channels, this detailed, single-source reference illustrates the principles of pharmacological analysis and receptor classification that are the basis of rational drug design.
Explains the experimental and theoretical methods used to characterize interactions between ligands and receptors-providing the pharmacological information needed to solve treatment problems and facilitate the drug design process
Demonstrating the achievements of the receptor-based approach in therapeutics and indicating future directions, Receptor-Based Drug Design
introduces novel computer-assisted strategies for the design of new agonists, antagonists, and inverse agonists for G-protein-coupled receptors
shows how to assess agonist concentration-effect curve data
discusses radioligand binding assays
presents new in vitro multiarray assays for G-protein-coupled receptors
explains the use of individual second messenger signaling responses in analyzing drug-receptor interactions
examines the role of electrophysiology in finding new drugs and drug targets
describes selectively acting b-adrenoceptor agonists and glucocorticoid steroids for asthma treatment
outlines the rationale for using angiotensin receptor antagonists
and more
Written by over 25 international authorities and containing nearly 1200 bibliographic citations, Receptor-Based Drug Design is a practical resource for pharmacologists, pharmacists, and pharmaceutical scientists; organic and medicinal chemists and biochemists; molecular biologists; biomedical researchers; and upper-level undergraduate and graduate students in these disciplines.

Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.

Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.

This work brigdges the compartmentalized undergraduate organic and biochemistry and biology subjects to the pharmacology and the clinical areas a modern pharmacy practice requires. The changes and constantly increasing responsibilities of today's pharmacist have dictated a restructuring of the pharmacy curriculum, including individual course content. This book reflects and addresses these developments. This is a well-written work that covers most major areas of pharmaceutical research. The text is presented in a logical and concise fashion being divided into chapters based upon therapeutic topic. This makes the work very useful for teaching a course in medicinal chemistry since therapeutic areas can be separately covered without having to make use of the entire book which overall contains a tremendous amount of information. This book is a significant contribution to understanding what medicinal chemistry is and how this science is used to develop new therapeutic agents.

More than a checklist of audit questions, this guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools will help you prepare checklists and standards so audits become more effective, consistent, and standardized. The book includes profiles of seasoned professionals in drug and device auditing, who share their experiences (the good and the bad)

Honey typically has a complex chemical and biochemical composition that invariably includes complex sugars, specific proteins, amino acids, phenols, vitamins, and rare minerals. It is reported to be beneficial in the treatment of various diseases, such as those affecting the respiratory, cardiovascular, gastrointestinal, and nervous systems, as well as diabetes mellitus and certain types of cancers; however, there is limited literature describing the use of honey in modern medicine. This book provides evidence-based information on the pharmaceutical potential of honey along with its therapeutic applications and precise mechanisms of action. It discusses in detail the phytochemistry and pharmacological properties of honey, highlighting the economic and culturally significant medicinal uses of honey and comprehensively reviewing the scientific research on the traditional uses, chemical composition, scientific validation, and general pharmacognostical characteristics. Given its scope, it is a valuable tool for researchers and scientists interested in drug discovery and the chemistry and pharmacology of honey.

Immunoassay development is a multidisciplinary activity involving a wide range of skills possessed by few laboratories. This presentation of tried and tested methods should enable scientists and researchers in the pharmaceutical and related industries to more rapidly and effectively develop immunoassays upon which their work is becoming heavily dependent.; Important methods are included for preparing Lapten-protein conjugates and raising the necessary antibodies, concentrating on polyclonal sera, as well as methods for the synthesis of radio and enzyme labelled tracers. Particular attention is paid to the requirements of the regulatory authorities such as the FDA (Food and Drug Administration) with respect to assay validation. Further chapters deal with assay development and optimization, curve fitting and quality control procedures.

This practical guide offers concise coverage of the scientific and pharmaceutical aspects of protein delivery from controlled release microparticulate systems-emphasizing protein stability during encapsulation and release.

This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry. Drawing from a range of expert perspectives in academia and industry, this collection offers an overarching dialogue about recent advances in biopharmaceutical applications, novel statistical and methodological developments, and potential future directions. The volume covers topics in subgroups in clinical trial design; subgroup identification and personalized medicine; and general issues in subgroup analyses, including regulatory ones. Included chapters present current methods, theories, and case applications in the diverse field of subgroup application and analysis. Offering timely perspectives from a range of authoritative sources, the volume is designed to have wide appeal to professionals in the pharmaceutical industry and to graduate students and researchers in academe and government.

Dr. Jean Huxsoll and a team of distinguished biotechnology industry experts from the U.S. and Europe offer a wealth of practical guidelines to designing, implementing, and managing QA systems to assure that biopharmaceutical products meet standards for safety purity, and potency. Quality Assurance for Biopharmaceuticals covers all important theoretical and practical concerns, including detailed guidelines to meeting GMP compliance; quality assurance of production; quality assurance of analytical methods; advanced documentation, sampling, and validation techniques; comprehensive coverage of regulatory issues in the U.S., Europe, and Japan; and much more.

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields

In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering.

A concise guide to mathematical modeling and analysis of pharmacokinetic data, this book contains valuable methods for maximizing the information obtained from given data. It is an ideal resource for scientists, scholars, and advanced students.

This unique reference examines the modern pharmaceutical compacting techniques used to form tablets out of powders-describing the physical structure of pharmaceutical compacts, the bonding phenomena that occur during powder compaction, and the compression mechanisms of pharmaceutical particles.

Although the role of liposomes in drug targeting has been discussed extensively in several reviews and books, there has been no comprehensive coverage of related methodology. This book constitutes the first attempt to put together all aspects of lipsome technology as applied to medical sciences. Volume I deals directly with methods for the preparation of liposomes and auxiliary techniques.

Recent technological advances have led to a rapid acceleration in our ability to gather genetic data. The complete genetic sequences are now known to several organisms and accelerated programmes are in place for sequencing many other genomes, including human. The speed with which complete sequencing can be accomplished will continue to increase as new technologies come online. In principle, the scope for developing new diagnostic techniques and drugs is now greater than at any time in human history, but the pathway from genetic information to usable drug is a long and complex one.

This exciting book brings together a high-calibre group of experts to discuss the practical application of genomic information to the development of drugs. The subjects covered include the current state of the art in sequencing technology, the applications of these new technologies to sequencing the genomes of various organisms, and the challenge of proteomics. Additional contributions deal with legal and ethical implications of the new uses of genetic data, and functional genomes from the point of view of the pharmaceutical industry.

Although the role of liposomes in drug targeting has been discussed extensively in several reviews and books, there has been no comprehensive coverage of related methodology. This book constitutes the first attempt to put together all aspects of lipsome technology as applied to medical sciences. Volume III is devoted to the growing variety of techniques yielding targeted liposomes and to approaches of studying liposomal behaviour in the biological milieu both in vitro and in vivo.

Advances in pharmacogenomics and proteomics, along with the introduction of recombinant DNA technology, have expanded the applications of pharmacology to encompass a range of disciplines. Biomedical researchers, protein specialists, and molecular biologists are all involved in the development and delivery of novel drugs. Therefore, students in a variety of life sciences now require grounding in pharmacology. Adding much new material, Introduction to Pharmacology, Third Edition familiarizes students with the curative action of specific drugs, along with current research and the multifaceted role of pharmacology in society. New to the third edition Chapters on smooth muscle pharmacology covering gastrointestinal and pulmonary pharmacology Pharmacology advances at the molecular level The historical background of the Watson Crick model of DNA Cutting edge topics such as RNA interference and dopamine signaling The text begins with a discussion on the absorption, distribution, metabolism, and elimination of drugs. Much emphasis is placed on pharmacokinetic aspects: how drugs produce an effect and the quantification of these effects for comparative purposes. Also the text describes substance abuse pharmacology and the evolution of drug laws. Several chapters deal with the development of drugs and challenges faced in drug discovery. Identifying both the therapeutic and toxicological aspects of drug use, Introduction to Pharmacology employs contemporary examples to help students become familiar with drug development and treatment, as well as possible adverse affects, and the impact of drug research and use on society today and into the future.

Phage Display in Biotechnology and Drug Discovery, Second Edition provides a comprehensive view of the impact and promise of phage display in drug discovery and biotechnology. Building on the success of its previous edition, the book discusses current theories, principles, and methods in the field and demonstrates applications for peptide phage display, protein phage display, and the development of novel antibodies. The book provides readers with an overview of the amazing breadth of the impact that phage display technology has had on the study of proteins in general as well as the development of proteins. It will be a valuable resource for those interested in using phage display and recombinant antibodies in basic research and drug discovery. Key Features: Describes the basic principles of phage display and the methods and systems that have been developed for key applications Outlines applications for peptide phage display in the development of vaccines and high- throughput screens as well as the exploration of protein-protein interactions and enzyme substrate characteristics Details the use of phage display in the engineering of protein stability, the identification and mapping of protein-protein interactions, and the development of catalysts Provides broad coverage of the impact of phage display technology on the development of protein therapeutics Presents expert opinions on future challenges in the field

Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.