Biological Drug Products

Design and Development of Biological, Chemical, Food and Pharmaceutical Products has been developed from course material from the authors’ course in Chemical and Biochemical Product Design which has been running at the Technical University Denmark for years. The book draws on the authors’ years of experience in academia and industry to provide an accessible introduction to this field, approaching product development as a subject in its own right rather than a sideline of process engineering In this subject area, practical experience is the key to learning and this textbook provides examples and techniques to help the student get the best out of their projects. Design and Development of Biological, Chemical, Food and Pharma Products aims to aid students in developing good working habits for product development. Students are challenged with examples of real problems that they might encounter as engineers. Written in an informal, student-friendly tone, this unique book includes examples of real products and experiences from real companies to bring the subject alive for the student as well as placing emphasis on problem solving and team learning to set a foundation for a future in industry. The book includes an introduction to the subject of Colloid Science, which is important in product development, but neglected in many curricula. Knowledge of engineering calculus and basic physical chemistry as well as basic inorganic and organic chemistry are assumed. An invaluable text for students of product design in chemical engineering, biochemistry, biotechnology, pharmaceutical sciences and product development. Uses many examples and case studies drawn from a range of industries. Approaches product development as a subject in its own right rather than a sideline of process engineering Emphasizes a problem solving and team learning approach. Assumes some knowledge of calculus, basic physical chemistry and basic transport phenomena as well as some inorganic and organic chemistry.

Enables readers to apply process dynamics and control theory to solve bioprocess and drug delivery problems The control of biological and drug delivery systems is critical to the health of millions of people worldwide. As a result, researchers in systems biology and drug delivery rely on process dynamics and control theory to build our knowledge of cell behavior and to develop more effective therapeutics, controlled release devices, and drug administration protocols to manage disease. Written by a leading expert and educator in the field, this text helps readers develop a deep understanding of process dynamics and control theory in order to analyze and solve a broad range of problems in bioprocess and drug delivery systems. For example, readers will learn how stability criteria can be used to gain new insights into the regulation of biological pathways and lung mechanics. They'll also learn how the concept of a time constant is used to capture the dynamics of diffusive processes. Readers will also master such topics as external disturbances, transfer functions, and input/output models with the support of the author's clear explanations, as well as: Detailed examples from the biological sciences and novel drug delivery technologies 160 end-of-chapter problems with step-by-step solutions Demonstrations of how computational software such as MATLAB and Mathematica solve complex drug delivery problems Control of Biological and Drug-Delivery Systems for Chemical, Biomedical, and Pharmaceutical Engineering is written primarily for undergraduate chemical and biomedical engineering students; however, it is also recommended for students and researchers in pharmaceutical engineering, process control, and systems biology. All readers will gain a new perspective on process dynamics and control theory that will enable them to develop new and better technologies and therapeutics to treat human disease.

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.

Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market. The book covers both clinical and nonclinical aspects for understanding drug-drug interactions as well as in vitro and in vivo studies for use in studying interactions at the drug discovery stage.

Sets forth the history, state of the science, and future directions of drug discovery Edited by Jie Jack Li and Nobel laureate E. J. Corey, two leading pioneers in drug discovery and medicinal chemistry, this book synthesizes great moments in history, the current state of the science, and future directions of drug discovery into one expertly written and organized work. Exploring all major therapeutic areas, the book introduces readers to all facets and phases of drug discovery, including target selection, biological testing, drug metabolism, and computer-assisted drug design. Drug Discovery features chapters written by an international team of pharmaceutical and medicinal chemists. Contributions are based on a thorough review of the current literature as well as the authors' firsthand laboratory experience in drug discovery. The book begins with the history of drug discovery, describing groundbreaking moments in the field. Next, it covers such topics as: Target identification and validation Drug metabolism and pharmacokinetics Central nervous system drugs In vitro and in vivo assays Cardiovascular drugs Cancer drugs Each chapter features a case study, helping readers understand how science is put into practice throughout all phases of drug discovery. References at the end of each chapter serve as a gateway to groundbreaking original research studies and reviews in the field. Drug Discovery is ideal for newcomers to medicinal chemistry and drug discovery, providing a comprehensive overview of the field. Veterans in the field will also benefit from the perspectives of leading international experts in all aspects of drug discovery.

DRUG TRANSPORTERS [b]Drug transporter fundamentals and relevant principles and techniques, featuring new and expanded chapters Drug Transporters: Molecular Characterization and Role in Drug Disposition provides in-depth analysis of the conceptual evolution and technical development for studying drug transporters. Contributions by an international panel of leading researchers address advances in transporters as drug targets, transporters in pharmacotherapy, the impact of transporters on drug efficacy and safety, the development of sophisticated model systems and sensitive assay methods, and more. Divided into two parts, the book first provides a thorough overview of relevant drug transporters before detailing the principles of drug transport and associated techniques. The updated and expanded third edition includes new chapters on in vitro-in vivo scale-up of drug transport activities, the ontogeny of drug transporters, the application of physiologically-based pharmacokinetic and pharmacodynamic modeling, and the use of transporters as therapeutic targets for diseases. Reflects the current state of the field and offers perspectives on future directions Covers basic knowledge, clinical outcomes, and emerging discoveries in transporter science Provides up-to-date information on drug transporter families, mechanisms, and clinical implications Includes extensive references and numerous figures and tables throughout Understandable for novices while offering sufficient depth for more experienced researchers, Drug Transporters: Molecular Characterization and Role in Drug Disposition, Third Edition is an excellent textbook for pharmacological or physiological science courses in drug/membrane transport, and an invaluable reference for academic or industrial scientists working in the transporter field and related areas of drug metabolism, pharmacokinetics, and pharmacodynamics.

The essentials of drug metabolism vital to developing new therapeutic entities Information on the metabolism and disposition of candidate drugs is a critical part of all aspects of the drug discovery and development process. Drug metabolism, as practiced in the pharmaceutical industry today, is a complex, multidisciplinary field that requires knowledge of sophisticated analytical technologies and expertise in mechanistic and kinetic enzymology, organic reaction mechanism, pharmacokinetic analysis, animal physiology, basic chemical toxicology, preclinical pharmacology, and molecular biology. With chapters contributed by experts in their specific areas, this reference covers: * Basic concepts of drug metabolism * The role of drug metabolism in the pharmaceutical industry * Analytical techniques in drug metabolism * Common experimental approaches and protocols Drug Metabolism in Drug Design and Development emphasizes practical considerations such as the data needed, the experiments and analytical methods typically employed, and the interpretation and application of data. Chapters highlight facts, common protocols, detailed experimental designs, applications, and limitations of techniques. This is a comprehensive, hands-on reference for drug metabolism researchers as well as other professionals involved in pre-clinical drug discovery and development.

Written by a leading authority with an excellent reputation and ability for writing a good narrative, Drug Discovery: A History is a far cry from simply a list of chemical structures. This lively new text considers the origins, development and history of medicines that generate high media interest and have a huge social and economic impact on society. Set within a wide historical, social and cultural context, it provides expanded coverage of pre-twentieth century drugs, the huge advances made in the twentieth century and the latest developments in drug research. Hallmark features: Up-to-the-minute information in drug research Vignettes of special and unusual information, and anecdotes Discusses drug prototypes from all sources More comprehensive than other volumes on history of drug discovery From the reviews: «…an excellent bibliographic resource for those interested in the background papers that serve as the foundation for discovery of specific drug entities.» JOURNAL OF MEDICAL CHEMISTRY, June 2006 «…a very comprehensive overview of drug development. It should be on the shelf on any aspiring pharmacist, medicinal chemist, or person interested in the history of therapeutic agents.» JOURNAL OF CHEMICAL EDUCATION, February 2006 «…a very readable and closely researched book…» CHEMISTRY & INDUSTRY, October 2005

The book «Drug Selectivity – An Evolving Concept in Medicinal Chemistry» provides a current overview and comprehensive compilation for medicinal chemists that discusses the effects of aiming for multiple targets on the entire drug development process. The result is a broad survey of current and future strategies for drug selectivity in medicinal chemistry with theoretical but also practical aspects. Different strategies are presented and evaluated, such as various design approaches, merged multiple ligands, discovery technologies and a broad range of successful examples of unselective drugs taken from all major disease areas. With its wide-ranging view of an emerging new paradigm in drug development, this handbook is of prime importance for every medicinal and pharmaceutical chemist.