Presentation at New Zealand-Australian Controlled Release Society Workshop
On 23 November 2017, Sara Hanning, lecturer in Clinical Pharmacy Practice at the Faculty of Medical and Health Sciences at the University of Auckland (New Zealand), was invited to give a talk on paediatric formulation development at the ‘New Zealand-Australian Controlled Release Society 2017 Joint Workshop’. Sara previously spent three years as a postdoctoral researcher at University College London (UCL) School of Pharmacy, UK, where she focused on the development of age-appropriate paediatric formulations. She was part of the UCL team working on the clonidine pharmaceutical development in the CloSed project. During the presentation entitled ‘Paediatric formulation development: Challenges in the translation of medicines from bench to bedside’, she included the CloSed project as a case study to exemplify a paediatric clinical trial aimed at studying a new formulation appropriate for children.
She provided an overview of the use of medicines in Paediatric Intensive Care Units and of the CloSed study, including aims and expected outputs, challenges from the methodological point of view, the main items of the Paediatric Investigation Plan (PIP) and considerations regarding the formulation development, the blinding and randomisation, the product labelling, shipment and the Investigational Medicinal Product (IMP) and Paediatric-Use Marketing Authorisation (PUMA) requirements.
Through the illustration of CloSed data, the presentation addressed practical considerations and challenges related to the pharmaceutical development of paediatric medicines and paediatric clinical trials, including appropriate strength selection and the development of a suitable dosing regimen that maintains the integrity of a double-blinded study design.