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.
Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries