title: Pediatric formulation issues identified in Paediatric Investigation Plans.
abstract: Since the European Paediatric Regulation was introduced in 2007, companies developing new medicinal products or new indications/routes of administration/pharmaceutical forms are obliged to present age-appropriate formulations for the pediatric population within a Paediatric Investigation Plan (PIP) to the European Medicines Agency. Our review highlights a number of discrepancies between what is proposed by applicants and what is considered acceptable by regulators, taking a sample of PIP applications assessed by a specialized Formulation Working Group (FWG) of the Paediatric Committee in 2009. This Working Group assessed 43% of the total number of validated PIP applications during that year. Ninety-two percent of the formulations assessed raised at least one issue, mainly relating to excipients, appropriateness of the route of administration or pharmaceutical form, dosing accuracy and patient's acceptability. A stronger focus on all these aspects, considering the targeted age range, the severity of the disease and the treatment duration, could streamline the development process.
authors.affiliation: European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK.
authors.forename: Blanca
authors.initials: B
authors.lastname: Quijano Ruiz
authors.forename: Emilie
authors.initials: E
authors.lastname: Desfontaine
authors.forename: Sara
authors.initials: S
authors.lastname: Arenas-López
authors.forename: Siri
authors.initials: S
authors.lastname: Wang
mesh_terms: D000367:Age Factors; D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence* / Q000379:methods; D002648:Child; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004335:Drug and Narcotic Control; D005060:Europe; D005079:Excipients / Q000737:chemistry; D006801:Humans; D010372:Pediatrics / Q000331:legislation & jurisprudence; D004364:Pharmaceutical Preparations / Q000008:administration & dosage
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations