Ebook: Pediatric Drug Development: Concepts and Applications
- Year: 2013
- Publisher: Wiley-Blackwell
- City: Hoboken
- Edition: 2nd
- Language: English
- pdf
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.
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.
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