Pediatric drug development concepts and applications /
Salvato in:
| Ente Autore: | |
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| Altri autori: | |
| Natura: | Elettronico eBook |
| Lingua: | inglese |
| Pubblicazione: |
Hoboken, N.J. :
Wiley,
2013.
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| Edizione: | 2nd ed. |
| Soggetti: | |
| Accesso online: | An electronic book accessible through the World Wide Web; click to view |
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Sommario:
- 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.