Strengthening the business of personalized medicine

In general, drugs often work in only half of the people who take them.  In addition, billions are spent to treat adverse drug reactions and other complications.  The personalized medicine approach is to elucidate the differences between patients who respond to a drug...

Drug Pharmacokinetic Comparison between Humans and Monkeys

To verify the availability of pharmacokinetic parameters in cynomolgus monkeys, hepatic availability (Fh) and the fraction absorbed (Fa) multiplied by intestinal availability (Fg) were evaluated to determine their contributions to absolute bioavailability (F) after...

New Regulatory and Enforcement Emphasis of FDA on Drug Safety

James N. Czaban (FDA Practice Group, Wiley Rein LLP) discusses trending topics of the FDA in regard to drug safety.  A perception exists that the FDA does far more in terms of actual product testing and oversight than it is actually authorized to do, which can result...

GI models aid preclinical drug development

Seventh Wave Laboratories now offer a battery of  gastrointestinal (GI) preclinical models (TIM) to help clients to assess the behavior of oral medications.  The in vitro models are licensed from TNO, a Dutch contract research organization.  The TIM system has proven...