This new edition of Drug Safety Evaluation presents an all-inclusive practical guide for those responsible for ensuring the safety of drugs and biologics, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated. This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Individual chapters address specific approaches to evaluating hazards, including problems and solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., cardiovascular safety, immunogenicity, carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching newproblems.
- ISBN: 978-0-470-25316-8
- Editorial: John Wiley & Sons
- Encuadernacion: Cartoné
- Páginas: 1200
- Fecha Publicación: 19/06/2009
- Nº Volúmenes: 1
- Idioma: Inglés