Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can
help predict the pharmacokinetics of drugs in humans and evaluate the effects of intrinsic (eg, …

In the future, biomarkers will play an increasingly important role in all phases of drug
development, including regulatory review. However, only a few of these biomarkers will become …

Predicting clinically significant drug interactions during drug development is a challenge for
the pharmaceutical industry and regulatory agencies. Since the publication of the US Food …

Since the introduction of the Biopharmaceutics Classification System (BCS)(1), its validity and
applicability have been the subject of extensive research and discussion (2). These efforts …

Background St John's wort(Hypericum perforatum) is a popular over‐the‐counter dietary
supplement and herbal remedy that has been implicated in drug interactions with substrates of …

A systems pharmacology model typically integrates pharmacokinetic, biochemical network,
and systems biology concepts into a unifying approach. It typically consists of a large number …

One of the most effective ways in which regulatory agencies communicate with sponsors and
guide drug development is through the issuance of guidances or guidelines. These can be …

… Frueh, Amur, Mummaneni, Burckart, and Lesko); and Medco Health Solutions, Inc., Franklin
… Lesko LJ. Personalized medicine: elusive dream or imminent reality? Clin Pharmacol Ther …

Using pharmacogenetics-based therapy, clinicians can estimate the therapeutic warfarin
dose by genotyping patients for single nucleotide polymorphisms (SNPs) that affect warfarin …

The market for molecular diagnostic tests is predicted to grow at extraordinary rates over the
next 10 years, fueled by pharmacogenetics and the elusive dream of personalized medicine…