The recent approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) of the 7 protein biomarker panel for use in detecting drug-induced kidney damage means that the biomarkers are now qualified at the same level by all of the ICH regulatory agencies....
Face it, the Food and Drug Administration’s (FDA) website is not the most user friendly of Regulatory options! لعبة بوكر تكساس For the incredibly low price of USD you can now have a comprehensive superset of 4 CD‑ROMs which provide an up-to-date collection of...
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...
