In February 2010 the FDA published “Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names” (Guidance), which describes in detail the FDA’s evaluation methodology for proposed proprietary drug names. By carefully...
Prior to drug approval, a potential new drug is usually subjected to the scrutiny of an expert advisory panel, selected by the FDA, who recommend whether or not the product should be marketed. These recommendations are non-binding. Industry analysts looked at...
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010 View more presentations from TigerTox. Historical Overview During the past 30 years, genetic toxicology testing has evolved technologically to play an important safety assessment role in the...
The Medicines and Healthcare products Regulatory Agency (MHRA) website now provides a new and easy to use directory for the pharmaceutical industry. Highlights include: News and hot topics Contacting the MHRA Fees Legislation, guidance, and policy Clinical trials...
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...
