Toxicology studies and studies on the effects of a new drug on such organs as the liver and kidneys occur during which step of the drug approval process in the United States?

Question

Quizplus · Accepted Answer

Chemical identification is the process of recognizing that a chemical may have the potential for useful physiologic effects.No testing has occurred before this step.Once an active chemical is isolated and identified,a series of animal studies examines its general effect on animals and effects on specific organs such as the liver or kidneys.Toxicology studies to examine mutagenicity,teratogenicity,effect on reproductive fertility,and carcinogenicity are also performed.Investigational New Drug (IND)approval is a three-phase process that involves administering the drug to human subjects.It is imperative that safety be established before this step is taken.New Drug Application occurs only after a successful IND process,when the U.S.Food and Drug Administration (FDA)approves the drug for general clinical use.

Toxicology Studies and Studies on the Effects of a New