Safe and effective medicines for children pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act / Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA), Institute of Medicine of the National Academies; Board on Health Scienbces Policy;Marilyn J. Field and Thomas F. Boat, editors.
| Format | Electronic |
| Publication Info | Washington, D.C. : The National Academies Press, [2012] |
| Description | xxiii, 408 pages : illustrations ; 24 cm |
| Supplemental Content | Full text available from Ebook Central - Academic Complete |
| Subjects |
| Other author/creator | Field, Marilyn J. (Marilyn Jane) |
| Other author/creator | Boat, Thomas F. |
| Other author/creator | Institute of Medicine (U.S.) |
| Other author/creator | National Research Council (U.S.) |
| Contents | Introduction -- Children's growth and development and pediatric drug studies -- Policy framework for BPCA and PREA -- Ethical issues in pediatric drug studies -- Safety and efficacy assessment in studies conducted under BPCA and PREA -- BPCA, PREA, and drug studies with neonates -- Outcomes of written requests, requirements, studies, and labelling changes -- Pediatric studies of biologics. |
| Bibliography note | Includes bibliographical references and index. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Genre/form | Electronic books. |
| LCCN | 2012472511 |
| ISBN | 9780309225496 (pbk.) |
| ISBN | 0309225493 (pbk.) |