This work provides a perspective on the qualification and verification of physiologically based
pharmacokinetic (PBPK) platforms/models intended for regulatory submission based on …

Metformin is a biguanide derivative used in the treatment of type II diabetes (T2D) and one
of the world's most widely prescribed drugs. Owing to its safety profile, it has been recently …

Physiologically‐based pharmacokinetic (PBPK) modeling has been extensively used to
quantitatively translate in vitro data and evaluate temporal effects from drug–drug interactions (…

Organic anion transporters play an essential role in the distribution and excretion of numerous
endogenous metabolic products and exogenous organic anions, including a host of …

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, …

This study aimed to derive quantitative abundance values for key hepatic transporters suitable
for in vitro–in vivo extrapolation within a physiologically based pharmacokinetic modeling …

Venetoclax, a selective B-cell lymphoma-2 inhibitor, is a biopharmaceutics classification
system class IV compound. The aim of this study was to develop a physiologically based …

Food can alter drug absorption and impact safety and efficacy. Besides conducting clinical
studies, in vitro approaches such as biorelevant solubility and dissolution testing and in vivo …

Over the last 10 years, 40% of approved oral drugs exhibited a significant effect of food on
their pharmacokinetics (PK) and currently the only method to characterize the effect of food on …

The International Consortium for Innovation and Quality (IQ) Physiologically Based
Pharmacokinetic (PBPK) Modeling Induction Working Group (IWG) conducted a survey across …