Book[edited by] Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis.
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.