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...
Despite greater emphasis on safety as a result of attrition, the application of toxicology (~6% of the total R&D budget) to the preclinical drug development process has remained largely unchanged for over 30 years! For this reason, the impetus to reduce safety...
James N. Czaban (FDA Practice Group, Wiley Rein LLP) discusses trending topics of the FDA in regard to drug safety. panjiva ivermectin import pharmex A perception exists that the FDA does far more in terms of actual product testing and oversight than it is actually...
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...
As the first phase in a greater transparency initiative, the FDA launched a web-based resource called FDA Basics, which provides basic information about the Agency and how it does it’s work. In addition, different Centers and Offices in the Agency will host...
Collaboration between the 2 of the world’s premier pharmaceutical regulatory bodies (FDA and EMEA) has increased markedly in the last few years, a process which has come largely in response to the rapid globalization of drug development, manufacturing, and production....
