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Pediatric drug development : concepts and applications / editors, Andrew E. Mulberg ... [et al.].
- Format:
- Book
- Language:
- English
- Subjects (All):
- Pediatric pharmacology.
- Drug development.
- Physical Description:
- 1 online resource (616 p.)
- Edition:
- 2nd ed.
- Place of Publication:
- Hoboken, N.J. : Wiley, 2013.
- Summary:
- Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development.
- 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.
- Notes:
- Description based upon print version of record.
- Includes bibliographical references and index.
- Description based on print version record and CIP data provided by publisher.
- ISBN:
- 9781118312056
- 1118312058
- 9781118312087
- 1118312082
- 9781118312131
- 1118312139
- OCLC:
- 827010652
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