Pediatric drug development concepts and applications /
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| Autor Corporativo: | |
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| Outros Autores: | |
| Formato: | Recurso Eletrônico livro eletrônico |
| Idioma: | inglês |
| Publicado em: |
Hoboken, N.J. :
Wiley,
2013.
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| Edição: | 2nd ed. |
| Assuntos: | |
| Acesso em linha: | An electronic book accessible through the World Wide Web; click to view |
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Sumário:
- pt. I. Past, present, and future of pediatric drug development
- pt. II. Ethical underpinnings
- pt. III. Regulatory guidelines for pediatric drug development
- pt. IV. Preclinical safety assessment
- pt. V. Pharmacological principles in pediatric drug development
- pt. VI. Clinical trial operations
- pt. VII. Clinical trial operations and good clinical trials
- pt. VIII. Clinical efficacy and safety endpoints
- pt. IX. Formulation, chemistry and manufacturing controls.