Nonclinical safety assessment a guide to international pharmaceutical regulations /

• Άλλοι συγγραφείς: Brock, William J., Hastings, Kenneth L.
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Chichester, West Sussex : Wiley, 2013.
• Θέματα: Drug development > International cooperation.; Drugs > Toxicology > International cooperation.; Drug Evaluation, Preclinical > standards.; Drug Approval > methods.; Drug Toxicity > prevention & control.; International Cooperation.; Legislation, Drug.; Toxicity Tests > standards.; MEDICAL > Drug Guides.; MEDICAL > Nursing > Pharmacology.; MEDICAL > Pharmacology.; MEDICAL > Pharmacy.; Electronic books.

Πίνακας περιεχομένων:

• Introduction to the development of drugs / Kathy McGown
• ICH / Ken Hastings
• USFDA / Bill Brock
• Latin America : MERCOSUR countries / Cristiana Leslie Corra
• Canada / Mark T. Goldberg
• EMEA / Adam Woolley
• Africa / Fariza Feraoun
• China / Lijie Fu
• Japan / Kazuichi Nakamura
• India / K.S. Rao
• Australia / Doug Francis
• Chronic repeat dose testing / Shana Azri-Meehan
• Carcinogenicity / James Popp
• Genotoxicity / Mark Powley
• Developmental and reproductive toxicology / Robert Parker
• Juvenile testing and pediatric claim / Melissa Tassinari
• Immunotoxicology / Leigh Ann Burns Naas
• Biologics / Chris Ellis
• Vaccines / Robert House
• Phototoxicity and photocarcinogenicity / Chris Sambuco
• Degradants, impurities excipients, and metabolites / Bob Osterberg.