Biopharmaceutics and Drug Hypersensitivity

Biopharmaceutics and Drug Hypersensitivity

Author: Paul Mossillo

Publisher:

Published: 2010

Total Pages: 0

ISBN-13: 9781607418306

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Severe hypersensitivity reactions (HSRs) to anticancer drugs often make it difficult to continue treatment, especially in paclitaxel, even when treated with prophylactic medication. The authors of this book analysed severe HSRs incidence in patients treated with modified premedication protocol and historically compared to that using standard premedication before 2004. It was found that the modified premedication protocol could successfully reduce the incidence of severe HSRs in patients treated with paclitaxel. Furthermore, substandard and faked formulations are a global burden of virtually all countries. The collapse of the former Soviet Union (FSU) in the nineties lead to the retardation of the formerly remarkable pharmaceutical industry and drug quality control system of FSU. This book describes the pharmacopoeial quality of three EU registered and three Russian Federation registered aciclovir formulations. The data indicates that the pharmacopoeial quality of the antimicrobial and antiviral formulations from the Russian Federation drug market is similar to the European competitors. Other chapters in this book evaluate bioequivalence in order to establish the interchangeability of generic drugs, describe the most important aspects of the cholinergic neurotransmission, as well as natural and synthetic compounds that are able to influence it as therapeutic or experimental drugs. The authors also provide a comprehensive overview of the clinical and practical aspects of corticosteroids-induced delayed hypersensitivity and its consequences on anti-inflammatory therapeutic choices.


Drug Hypersensitivity

Drug Hypersensitivity

Author: Werner J. Pichler

Publisher: Karger Medical and Scientific Publishers

Published: 2007-01-01

Total Pages: 440

ISBN-13: 3805582692

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Approaches the phenomenon of drug hypersensitivity in a comprehensive manner. Besides epidemiological aspects, it addresses the immunological mechanisms underlying these complicated reactions which go far beyond the IgE-mediated drug allergies also considered in this book. The book also covers clinical manifestations and new diagnostic methods, and introduces some recetly established animal models. Many topics are treated from multiple perspectives, and the 33 chapters are thoroughly cross-referenced.


Immunogenicity of Biopharmaceuticals

Immunogenicity of Biopharmaceuticals

Author: Marco Weert

Publisher: Springer Science & Business Media

Published: 2008-02-06

Total Pages: 269

ISBN-13: 0387758410

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Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. 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.


Preclinical Safety Evaluation of Biopharmaceuticals

Preclinical Safety Evaluation of Biopharmaceuticals

Author: Joy A. Cavagnaro

Publisher: John Wiley & Sons

Published: 2013-03-07

Total Pages: 1012

ISBN-13: 1118679385

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"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.