Nonclinical safety assessment a guide to international pharmaceutical regulations /
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| Autor Corporativo: | |
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| Outros Autores: | , , |
| Formato: | Recurso Electrónico livro electrónico |
| Idioma: | inglês |
| Publicado em: |
Chichester, West Sussex :
John Wiley & Sons,
2013.
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| Assuntos: | |
| Acesso em linha: | An electronic book accessible through the World Wide Web; click to view |
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Sumário:
- 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.