Article ID Journal Published Year Pages File Type
5817460 International Journal of Pharmaceutics 2016 5 Pages PDF
Abstract

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.

Graphical abstractDownload high-res image (195KB)Download full-size image

Related Topics
Health Sciences Pharmacology, Toxicology and Pharmaceutical Science Pharmaceutical Science
Authors
, , , , , , ,