“Current knowledge, challenges and innovations in developmental pharmacology: a combined c4c expert group and ESDPPP White paper” has been published by British Journal of Pharmacology
A new paper from c4c experts provides a summary of current evidence and provides scientific insight and suggestions to incorporate the latest knowledge on developmental pharmacology and innovative techniques into paediatric drug development.
Developmental pharmacology refers to impact of maturation on drug disposition (pharmacokinetics, PK) and drug effects (pharmacodynamics, PD). There has been remarkable progress made over the years in this area. Knowledge gaps have been identified to ensure that paediatric drug development is safe and effective. The following suggestions were made, and include:
- profiling drug metabolites concentrations can support compound-specific PK studies
- having real world paediatric data to support high quality paediatric data endpoints
- considering PK and PD characterisation in paediatric subgroups from the earliest drug development stages
- continuous improvements on targeted and efficient clinical trial designs should become standard in paediatric drug development
The paper highlights the value of incorporating developmental pharmacology expertise into trial designs, and this should be integrated in paediatric drug development, as offered as part of strategic feasibility advice from c4c.
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