Books about Biopharmaceuticals from Amazon.com

Applied Biopharmaceutics and Pharmacokinetics provides the reader with a basic understanding of the principles of biopharmaceutics and pharmacokinetics as applied to drug product development and drug therapy. The revised and updated fifth edition of this popular text remains unique in teaching the student the basic concepts that may be applied to understanding the complex issues associated with the processes of drug delivery and the essentials of safe and effective drug therapy.

NEW TO THIS EDITION:
*Chapter on Pharmacogenetics
*Explanation of the role of pharmacogenetics in drug metabolism using examples of drugs that frequently lead to drug interactions
*Chapter on the Impact of Biopharmaceutics on Drug Product Quality and Clinical Efficacy
*Enhanced applications to pharmacy practice with the emphasis on biopharmaceutics, pharmacokinetics and drug delivery
*Updated coverage of dosing in clinical situations including dosing in special populations and what to do with a skipped dose in patients
*Additional practice problems and clinical examples
*Newest concepts in biopharmaceutics and pharmacokinetics
*Reorganized content to follow today's curriculum in pharmaceutical sciences.
Price: $54.60 [Notify me when price goes down.]

In the last two decades, the discipline of biopharmaceutics has undergone considerable advances, particularly with regard to bioavailability and bioequivalence as they relate to product quality and regulatory standards of approval. Textbooks in the field have not been able to keep up with the growth of current and emerging applications of regulatory aspects of biopharmaceutics.

Biopharmaceutics Applications in Drug Development fills this gap. This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.

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Price: $115.16 [Notify me when price goes down.]

An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system..
Price: $196.26 [Notify me when price goes down.]

A clear, straightforward resource to guide you through preclinical drug development

Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques.

Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Among the key topics covered are:
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Modeling and informatics in drug design
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Bioanalytical chemistry
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Absorption of drugs after oral administration
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Transporter interactions in the ADME pathway of drugs
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Metabolism kinetics
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Mechanisms and consequences of drug-drug interactions

Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage.

This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin..
Price: $150.88 [Notify me when price goes down.]

The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceutical developers. Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules. Using clear language along with numerous case studies, examples, tables, flow charts, and schematics, the book presents perspectives from experienced professionals involved in purification processes and industrial downstream unit operations. The authors provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. Chapter topics include harvest by centrifugation and filtration, expanded bed chromatography, protein refolding, modes of preparative chromatography, methodologies for resin screening, membrane chromatography, protein crystallization, viral filtration, ultrafiltration/diafiltration, implementing post-approval downstream process changes for an antibody product, and future trends. Ideal for both new and experienced scientists in the biopharmaceutical industry and students, Process Scale Bioseparations for the Biopharmaceutical Industry is a comprehensive resource for all topics relevant to industrial process development..
Price: $147.92 [Notify me when price goes down.]

(Kluwer Academic) BioPharmaceutical Quality Solutions, Carlsbad, CA. Provides insight and practical suggesting in a common sense business approach for managing the Chemistry, Manufacturing & Controls (CMC) regulatory compliance requirements for biopharmaceuticals. Explains the biopharmaceutical CMC regulatory compliance, strategy development, and more..
Price: $113.99 [Notify me when price goes down.]

"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies."
—From the Afterword by Anthony D. Dayan

Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials:

• Includes an overview of biopharmaceuticals with information on regulation and methods of production
• Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan
• Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals
• Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals
• Covers transitioning from preclinical development to clinical trials

This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel..
Price: $90.49 [Notify me when price goes down.]

Written by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages..
Price: $179.11 [Notify me when price goes down.]

Addresses the challenges faced in the design, development, and scale-up of large-scale chromatographic processes. Offers fundamental analysis of the underlying physiochemical principles. .
Price: $141.39 [Notify me when price goes down.]

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology.

This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery..
Price: $57.99 [Notify me when price goes down.]