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  • Book
    [edited by] Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis.
    Digital : Wiley2013
    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.