Open AccessCurrent Scientific Considerations to Verify Physiologically‐Based Pharmacokinetic Models and Their Implications for Locally Acting Products
Author(s) -
Zhao Liang,
Seo Paul,
Lionberger Robert
Publication year - 2019
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12421
Subject(s) - physiologically based pharmacokinetic modelling , bioequivalence , drug , pharmacology , pharmacokinetics , biochemical engineering , drug development , computer science , risk analysis (engineering) , computational biology , medicine , engineering , biology
Challenges to verify physiologicallybased pharmacokinetic (PBPK) models are significant for locally acting product (LAP) given actionsite drug concentration is not easily measurable and when systemic pharmacokinetics (PK) do not reflect actionsite drug delivery or are not detectable. As such, regulatory or scientific programs that generate clinically relevant in vitro/in vivo data for the product or data from an array of products with relevant formulation properties and use conditions become critical for model verification.