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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), Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Marilyn J. Field and Thomas F. Boat, editors

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    QV733 AA1
    S1281 2012
     
    959203 (Shelf),BOK
    Safe and effective medicines for children : pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.

         xxiii, 408 pages : illustrations ; 24 cm.
         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.

         ISBN 9780309225496
         .-ISBN 0309225493.
         
         1. Clinical Trials as Topic - United States - Congress - legislation & jurisprudence 2. Clinical Trials as Topic - United States - Congress - standards 3. Adolescent - United States - Congress 4. Child - United States - Congress 5. Drug Approval - United States - Congress - legislation & jurisprudence 6. Drug Evaluation - United States - Congress - legislation & jurisprudence 7. Drug Industry - United States - Congress - legislation & jurisprudence 8. Infant - United States - Congress.I. Field, Marilyn J. II. Boat, Thomas F., III. Institute of Medicine (U.S.). $bCommittee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA). IV. National Research Council (U.S.). V. Title
         Library : UiTM Shah Alam
    Accn No.Item StatusAdd IdLocationSMDItem Category
    959203ShelfPERP. PERUBATAN TAR KAMPUS SG. BULOH(PPSB)BOOKRAK TERBUKA (MEDICAL SCI)
    959204ShelfPERP. PERUBATAN TAR KAMPUS SG. BULOH(PPSB)BOOKRAK TERBUKA (MEDICAL SCI)

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