Books about Biopharmaceuticals from Amazon.com

The primary emphasis of this book is on the application and understanding of concepts Basic theoretical discussions of the principles of biopharmaceutics and pharmacokinetics are provided, along with illustrative examples and practice problems and solutions to help the student gain skill in practical problem solving..
Price: $49.86 [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: $113.94 [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: $18.96 [Notify me when price goes down.]

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..
Price: $111.20 [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: $183.96 [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: $148.20 [Notify me when price goes down.]

• An important reference which provides an overview of the current and recently introduced methodologies for testing the immunotoxic risks in drug candidates
• Helps readers understand the significance of the methods and approaches to immunotoxicology testing
• Aids drug scientists in industry and regulatory areas to consolidate approaches to immunotox testing
• Offers a definitive assessment of nonclinical models to study the toxic impacts (bio)pharmaceuticals can have on the immune system
• Includes chapter authors from across the pharma industry, bringing a real-world and applied perspective to immunotox testing
  

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Price: $97.18 [Notify me when price goes down.]

A particular issue for biopharmaceuticals that has not been addressed comprehensively in any book, is the potential of an immune response to the biopharmaceutical product. That is, the human body marks the drug as a foreign body, and develops antibodies against the drug. These antibodies may be relatively harmless, but may also cross-react with the endogenous compound, causing autoimmunogenicity. Recent adverse experiences in Europe with Janssen-Ortho s blockbuster product Eprex has increased the attention towards potential immunogenicity of biopharmaceuticals, above all from the regulatory agencies.

This book is intended to give a broad overview of the current state-of-the-art regarding the immune response to biopharmaceuticals. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.

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Price: $141.75 [Notify me when price goes down.]

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs defines biotechnology from the perspective of pharmaceuticals. The first section focuses on the process of transforming a biologic macromolecule into a therapeutic agent, while the second section provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail is also provided in the second section for each FDA approved, recombinantly derived biopharmaceutical for each category of macromolecule. The final section looks to the future and the new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. This last section discusses various drug delivery strategies while also describing gene and cell therapy strategies..
Price: $69.89 [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: $194.87 [Notify me when price goes down.]