Preclinical Safety Evaluation of Biopharmaceuticals

22.08.2008

Englisch

9780470108840

John Wiley & Sons

Nein

1064

Gebundene Ausgabe

A Science-Based Approach to Facilitating Clinical Trials

Joy A. Cavagnaro, PhD, is the President of Access BIO, a consultancy specializing in science-based regulatory strategies and product development services. She has over twenty-five years of experience in biotech spanning academia, the CRO and biotech industries, and government. During her tenure at the FDA, Dr. Cavagnaro served as rapporteur for ICH S6. She is founder and past chair of the BIO Preclinical Safety Expert Group (BioSafe) and was the U.S. BIO Representative to the 2006 ABPI/BIA Early Stage Clinical Trials Taskforce.Dr. Cavagnaro is currently North American Chair of the Drug Information Association-Biotech SIAC and Chair of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy. She serves on a number of scientific advisory boards and lectures internationally in the area of preclinical development of novel therapies.

Biopharmazie, Biotechnologie, Chemie, Chemistry, Drug Discovery & Development, Medical Science, Medizin, Pharmacology & Pharmaceutical Medicine, Pharmakologie u. Pharmazeutische Medizin, Toxicology, Toxikologie, Wirkstoffforschung u. -entwicklung

PNB - Medizinische Chemie, Pharmazeutische Chemie

Foreword. Acknowledgments. Contributors. Part I: Background. Part II: Principles of Preclinical Development. Part III: Current Practices in Preclinical Development. Part IV: Selection of Relevant Species. Part V: Safety/Toxicity Endpoints. Part VI: Specific Considerations Based on Product Class. Part VII: Preclinical Study Design, Implementation, and Analysis. Part VIII: Transitioning From Preclinical Development to Clinical Trials. Part IX: Afterword. Index.

238 mm

16.4 cm