: pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
نام نخستين پديدآور
\ 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
وضعیت نشر و پخش و غیره
محل نشرو پخش و غیره
Washington, D.C
نام ناشر، پخش کننده و غيره
: The National Academies Press
تاریخ نشرو بخش و غیره
, 2012
مشخصات ظاهری
نام خاص و کميت اثر
351 p.
ساير جزييات
:ill.
ابعاد
;24 cm
یادداشتهای مربوط به کتابنامه ، واژه نامه و نمایه های داخل اثر
متن يادداشت
Index
متن يادداشت
Bibliography
یادداشتهای مربوط به مندرجات
متن يادداشت
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.