title: Towards the development of a paediatric biopharmaceutics classification system: Results of a survey of experts.
abstract: The aim of this research survey was to understand current global thinking around the need for and development of a paediatric biopharmaceutics classification system (pBCS) to be used for the development of paediatric medicines and regulatory purposes (e.g. Biowaivers). A literature review highlighted the paucity of data in this area and therefore a survey was developed to better understand this topic to identify areas of common thinking and highlight future research needs. Global experts in paediatric biopharmaceutics were identified from existing networks and public forums. An online survey was developed and circulated broadly to maximise participation. Sixty individuals (including academics, health care professionals, pharmaceutical industry scientists and regulators) completed the survey, bringing together their views on the need for a pBCS. The results highlighted that the area of greatest concern was the definition of BCS II and IV drugs within this population and additional research is required to generate evidence to underpin this issue. In questions relating to permeability and dissolution consensus was generally reached within the expert population suggesting that little additional research is required to define suitable criteria. More than 90% of those experts who participated agreed that a pBCS would be useful for paediatric populations with a greater need identified for the younger populations (newborn and infants compared to adolescents). The results presented will facilitate further discussion and research into the evidence to underpin a relevant pBCS. These results highlight the need for additional evidence and guidance in this area.
authors.affiliation: School of Pharmacy, Institute of Clinical Sciences, Robert Aitken Building, University of Birmingham, Edgbaston, B15 2TT, UK. Electronic address: h.k.batchelor@bham.ac.uk.
authors.forename: Hannah
authors.initials: H
authors.lastname: Batchelor
authors.affiliation: GlaxoSmithKline, New Frontiers Science Park, Third Avenue, Harlow, Essex CM19 5AW, UK.
authors.forename: Terry
authors.initials: T
authors.lastname: Ernest
authors.affiliation: Pharmaceutical Development, AstraZeneca R&D, Macclesfield, UK.
authors.forename: Talia
authors.initials: T
authors.lastname: Flanagan
authors.affiliation: Department of Pharmacy, Ernst Moritz Arndt University, Greifswald, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Klein
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Roy
authors.initials: R
authors.lastname: Turner
authors.affiliation: Department of Pharmacy and Pharmacology, University of Bath, Bath, UK.
authors.forename: Nikoletta
authors.initials: N
authors.lastname: Fotaki
authors.affiliation: Pharmaceutical Sciences, MSD, Hoddesdon, UK.
authors.forename: David
authors.initials: D
authors.lastname: Storey
mesh_terms: D000293:Adolescent; D001702:Biopharmaceutics / Q000145:classification* / Q000639:trends; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D010372:Pediatrics / Q000145:classification* / Q000639:trends; D011795:Surveys and Questionnaires
keywords: BCS; Biopharmaceutics; Dissolution; Paediatric; Permeability; Solubility; Survey