Best practices for selection of excipients for paediatrics – Workshop reflection

The development of age appropriate formulations for the paediatric population has become one key areas focus pharmaceutical industry - with a subsequent influence on excipient use. Selection excipients safety and tolerability is major hurdle in formulation development. Various factors selection excipients, including target group, route administration dosage form. Evaluation these clear rationale justification expected by regulators when it comes to selecting formulation. Scientists are encouraged apply principle benefit risk balance assess suitability specific whom intended. In order understand how scientists approach task establishing analysis, workshop was organised European Paediatric Formulation Initiative (EuPFI) reflect current scenario different practices employed formulations. Aspects assessed were also canvassed. Finally, participants asked comment use may differ from considerations applied other groups. Based discussion, some recommendations questions consider emerged regarding drug These best practice provided good starting point more systematic strategy