Drug Safety Evaluation

Beschreibung

The definitive safety guide to all aspects of the drug development process The third edition of Drug Safety Evaluation continues and expands on the comprehensive resource its predecessors offered - an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. In the new edition, changes and updates reflect the many changes in the scope of products (small synthetic, large protein moieties and cells and tissues), harmonized global and national regulatory requirements, the therapeutic development process, and available technologies to identify and evaluate the relevance of potential patient risks. They address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Drawing upon over 39 years of experience, author Shayne Gad explains the scientific and philosophical bases for evaluating specific concerns (e.g., carcinogenicity, developmental toxicity, immunogenicity and immunotoxicity) to provide both understanding and guidance for approaching new problems. Individual chapters address not only the general cases for safety evaluation of small and large molecules, but also all the significant major sub-cases: imaging agents, dermal and inhalation route drugs, vaccines, and gene-therapy products. Among the wide variety of topics covered are: Data Mining Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Evaluation of human tolerance and safety in clinical trials Statistics Impurity assessment and qualification QSAR and in vitro alternative methods
Diese neue Auflage von Drug Safety Evaluation als praktischer Leitfaden bietet eine Road Map für die Leistungsfähigkeit und Bewertung von Sicherheitsüberprüfungen als integraler Bestandteil bei der Entwicklung neuer Arzneimittel und Therapeutika. Dieses Buch wurde vollständig überarbeitet, bleibt aber den Kernzielen der Vorgängerausgaben treu. Es ist ein umfasssender und praxisorientierter Leitfaden für diejenigen, die für die Entwicklung neuer Arzneimittel verantwortlich sind, die Sicherheit einer immer größer werdenden Zahl an Therapeutika gewährleisten müssen, und die solche Maßnahmen finanzieren.

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Shayne Cox Gad

Themen in »Drug Safety Evaluation«

Arzneimittelsicherheit Chemie Chemistry Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie Pharmakologie u. Pharmazeutische Medizin Toxicology Toxikologie Veterinärmedizin Veterinärmedizin / Pharmakologie, Toxikologie, Therapeutik Veterinary Medicine Veterinary Pharmacology, Toxicology & Therapeutics

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