Quality and clinical supply considerations of Paediatric Investigation Plans for IV preparations-A case study with the FP7 CloSed project.
A Paediatric Investigation Plan (PIP) is a development plan that aims to ensure that sufficient data are obtained through studies in paediatrics to support the generation of marketing authorisation of medicines for children. This paper highlights some practical considerations and challenges with respect to PIP submissions and paediatric clinical trials during the pharmaceutical development phase, using the FP7-funded Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit (CloSed) project as a case study. Examples discussed include challenges and considerations regarding formulation development, blinding and randomisation, product labelling and shipment and clinical trial requirements versus requirements for marketing authorisation. A significant quantity of information is required for PIP submissions and it is hoped that future applicants may benefit from an insight into some critical considerations and challenges faced in the CloSed project.
Department of Pharmaceutics, UCL School of Pharmacy, London, UK. Electronic address: s.hanning@ucl.ac.uk.
Sara M
SM
Hanning
Department of Pharmaceutics, UCL School of Pharmacy, London, UK.
Mine
M
Orlu Gul
Therakind Ltd, London, UK.
Jackie
J
Winslade
Intensive Care and Department of Pediatric Surgery, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Manuel A
MA
Baarslag
Department of Paediatrics and Adolescent Medicine, University Hospital Erlangen, Erlangen, Germany.
Antje
A
Neubert
Department of Pharmaceutics, UCL School of Pharmacy, London, UK.
Catherine
C
Tuleu
D061605:Administration, Intravenous; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003000:Clonidine / Q000008:administration & dosage / Q000592:standards* / Q000600:supply & distribution*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000592:standards* / Q000600:supply & distribution*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010372:Pediatrics / Q000379:methods / Q000592:standards*
D006993:Hypnotics and Sedatives; D003000:Clonidine
Clinical trials; Clonidine; Formulation; Paediatric Investigation Plan; Paediatrics