Shayne C. Gad

Safety Pharmacology in Pharmaceutical Development (eBook, PDF)

Approval and Post Marketing Surveillance, Second Edition

• Format: PDF

Produktbeschreibung

Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard-particularly in individuals with compromised or limited organ system functions.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 213
• Erscheinungstermin: 26. April 2012
• Englisch
• ISBN-13: 9781439845684
• Artikelnr.: 39484299

Autorenporträt

Shayne Cox Gad is Principal at Gad Consulting Services in Cary, North Carolina. He has over 33 years experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries.

Inhaltsangabe

Safety Pharmacology: Background
History
Issues
and Concerns. Regulatory Requirements: ICH
FDA
EMA
and Japan. Principles of Screening and Study Design. Cardiovascular System. Central Nervous System. Respiratory System. Renal Function. The Gastrointestinal System. The Immune System.