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.

Clinical trials, Clonidine, Formulation, Paediatric Investigation Plan, Paediatrics
dx.doi.org/10.1016/j.ijpharm.2016.04.051, hdl.handle.net/1765/91661
International Journal of Pharmaceutics
This work was funded by the European Commission 7th Framework Programme; grant id fp7/602453 - Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit (CLOSED)
Department of Intensive Care

Hanning, S.M, Orlu Gul, M, Winslade, J, Baarslag, M.A, Neubert, A, & Tuleu, C. (2016). Quality and clinical supply considerations of Paediatric Investigation Plans for IV preparations-A case study with the FP7 CloSed project. International Journal of Pharmaceutics, 511(2), 1158–1162. doi:10.1016/j.ijpharm.2016.04.051