[edited by] Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis.
وضعیت ویراست
وضعيت ويراست
Second edition.
مشخصات ظاهری
نام خاص و کميت اثر
1 online resource
یادداشتهای مربوط به کتابنامه ، واژه نامه و نمایه های داخل اثر
متن يادداشت
Includes bibliographical references and index.
یادداشتهای مربوط به مندرجات
متن يادداشت
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.
بدون عنوان
0
یادداشتهای مربوط به خلاصه یا چکیده
متن يادداشت
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.