The Challenges of Pediatric Drug Development.

ABSTRACT:

Introduction and background

"Pediatric Drug Development" is being used to describe not the development of drugs for children, but rather the planning & conducting separate efficacy and safety (E&S) studies requested/demanded by regulatory authorities designed to produce pediatric labels. Pediatric studies required for drug approval enroll "children"; defined as <17 years of age (US Food and Drug Administration [FDA])/ <18 years (European Union [EU]). The medical rationale for study designs was examined.

Material & methods

International industry-sponsored pediatric E&S studies registered in www.clinicaltrials.gov were analysed along with the history of US/EU laws, published literature, internet-retrieved regulatory documents, and regulatory/ American Academy of Pediatrics (AA

SUBMITTER: Rose K 

PROVIDER: S-EPMC6677568 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature