Books about Biopharmaceutical 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: $39.99 [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: $17.46 [Notify me when price goes down.]

"Animal Cell Technology: from Biopharmaceuticals to Gene Therapy" provides a comprehensive insight into biological and engineering concepts related to mammalian and insect cell technology, as well as an overview of the applications of animal cell technology. Part 1 of the book covers the Fundamentals upon which this technology is based and covers the science underpinning the technology. Part 2 covers the Applications from the production of therapeutic proteins to gene therapy. The authors of the chapters are internationally-recognized in the field of animal cell culture research and have extensive experience in the areas covered in their respective chapters..
Price: $176.00 [Notify me when price goes down.]

Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand year. These early efforts focused on food. In recent times, freeze-drying has advanced to the point where it is a common practice for biopharmaceuticals, including blood plasma and vaccines. Lyophilization is still a method of choice for preservation of the growing list of biopharmaceutical products. This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.

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Price: $171.01 [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: $111.20 [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: $69.87 [Notify me when price goes down.]

Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, including the current methods, processes, technologies and equipment, and brings you up-to-date with the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries.

An essential, comprehensive, source for all professionals involved with filtration and purification practices and compliance, this text

· addresses recent biotechnology-related processes and advanced technologies, such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and medium and buffer filtration

· presents detailed updates on the latest FDA and EMEA regulatory requirements involving filtration and purification practices

· describes current industry quality standards and validation requirements and provides guidance for compliance

Audience:.
Price: $291.62 [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: $151.50 [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: $191.11 [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: $139.43 [Notify me when price goes down.]