Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

The application of physiologically based pharmacokinetic (PBPK) modeling has developed
rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery …

We assess the advancement of physiologically based pharmacokinetic (PBPK) modeling
and simulation (M&S) over the last 20 years (start of 2000 to end of 2019) focusing on the …

Classic pharmacokinetics (PK) rarely takes into account the full knowledge of physiology
and biology of the human body. However, physiologically based PK (PBPK) is built mainly …

Personalized medicine strives to deliver the 'right drug at the right dose'by considering inter-
person variability, one of the causes for therapeutic failure in specialized populations of …

For ethical and cost-related reasons, use of animals for the assessment of mode of action,
metabolism and/or toxicity of new drug candidates has been increasingly scrutinized in …

Novel oral anticoagulants (NOACs)(rivaroxaban, dabigatran, apixaban) have been
approved by international regulatory agencies to treat atrial fibrillation and venous …

During regulatory review of clinical pharmacology data in new drug applications and
biologics license applications, questions are routinely asked about how intrinsic factors (eg …

Physiologically based pharmacokinetic (PBPK) models are built using differential equations
to describe the physiology/anatomy of different biological systems. Readily available in vitro …

The occurrence of drug–drug interactions (DDIs) can significantly affect the safety of a
patient, and thus assessing DDI risk is important. Recently, physiologically based …