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Article
Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis
Current regulatory guidelines on drug-food interactions recommend an early assessment of food effect to inform clinical dosing instructions, as well as a pivotal food effect study on the to-be-marketed formula...
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Article
Correction to: Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective
An Erratum to this paper has been published: https://doi.org/10.1208/s12248-020-00535-z
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Article
Open AccessUse of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective
The effect of food on pharmacokinetic properties of drugs is a commonly observed occurrence affecting about 40% of orally administered drugs. Within the pharmaceutical industry, significant resources are inves...
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Article
PBPK Absorption Modeling: Establishing the In Vitro–In Vivo Link—Industry Perspective
The establishment of an in vitro–in vivo correlation (IVIVC) is considered the gold standard to establish in vivo relevance of a dissolution method and to utilize dissolution data in the context of regulatory bio...
