The Federal Register and the ICH S9 Guidance for the nonclinical evaluation for anticancer pharmaceuticals issued today. The guidance provides recommendations for preclinical studies for the development of pharmaceuticals, including both drugs and biotechnology...
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...
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...
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....
