Nonclinical safety assessment a guide to international pharmaceutical regulations /
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| Collectivité auteur: | |
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| Autres auteurs: | , , |
| Format: | Électronique eBook |
| Langue: | anglais |
| Publié: |
Chichester, West Sussex :
John Wiley & Sons,
2013.
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| Sujets: | |
| Accès en ligne: | An electronic book accessible through the World Wide Web; click to view |
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Table des matières:
- 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.