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 InfoWashington, D.C. : The National Academies Press, [2012]
Descriptionxxiii, 408 pages : illustrations ; 24 cm
Supplemental ContentFull text available from Ebook Central - Academic Complete
Subjects

Other author/creatorField, Marilyn J. (Marilyn Jane)
Other author/creatorBoat, Thomas F.
Other author/creatorInstitute of Medicine (U.S.)
Other author/creatorNational 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 noteIncludes bibliographical references and index.
Access restrictionAvailable only to authorized users.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2012472511
ISBN9780309225496 (pbk.)
ISBN0309225493 (pbk.)