IQ Webinar: Oral PBPK to Support BE Evaluation for Pediatric Drugs
March 2, 2023
Sponsored by the IQ Drug Product Leadership Group (DPLG)
Presented by the IQ DPLG Pediatric Working Group
Hannah Batchelor, Professor Hannah Batchelor
Strathclyde Institute of Pharmacy and Biomedical Sciences
Bioequivalence of generic products is typically obtained using biowaivers based on adult systems or via the use of clinical testing in an adult population. The extrapolation of equivalence obtained in adults is assumed to be sensible when such products are used in a paediatric population. This presentation will explore the use of biorelevant dissolution conditions to better reflect characterisation of the volume of GI fluids and composition of these fluids in a paediatric population and the integration of the resulting profiles into PBPK software to identify the best match to existing data. A carbamazepine tablet is used as a case study to demonstrate the work.
The integration of such dissolution into PBPK can further optimise predictions of performance. The use of in vitro dissolution coupled with PBPK testing is of immense value for paediatric products where testing in the end-user population is complicated by the ethical burden of conducting studies. Further work is ongoing to explore a broader range of drug products to better understand the wider use of a volume of 200mL for paediatric populations, however, this work is limited due to the very low availability of good-quality clinical data in paediatric populations (particularly the very young) that can be used to verify the models developed.
This is a public webinar. IQ membership is not for registration.