Interesting note from Neil Parrott of Roche.
The projection of food effect in children by direct transfer from studies in adults is not optimal. Although clinical data on pediatric food effects are very limited, several cases have shown distinct behavior in children compared to adults and so better methods are needed. Physiologically based biopharmaceutics modeling provides a framework integrating knowledge on age-dependent physiology and food effect mechanisms and has already shown its value for the projection of food effects in adults and-in a very few examples-in children. however there is a room for improvement in PBBB...interesting read with this free access article.
Food Effect in Pediatric Populations: Current Practice, Challenges, and Future Potential for Use of Physiologically Based Biopharmaceutics Modeling (wiley.com)
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Sandip Tiwari Ph.D.
Head of Technical Services, Pharma Solutions, NA
BASF Corporation
Tarrytown NY
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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