On 19 May 2010, a FDA task force proposed 21 ways that the Agency could release more information to the public in areas like drug evaluation, including information about safety problems with the drugs and devices it rejects. Although the FDA has long operated under...
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...
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...
