Pediatric drug development : concepts and applications / / editors, Andrew E. Mulberg ... [et al.].
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| Year of Publication: | 2013 |
| Edition: | 2nd ed. |
| Language: | English |
| Online Access: | |
| Physical Description: | xiv, 610 p. :; ill. (some col.) |
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Table of Contents:
- 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.