IND Application and IND Enabling Studies

Before a new drug candidate can move from pre-clinical trials (testing on lab animals) to clinical trials (testing on human volunteers), regulatory bodies require that it pass an early stage drug application. With the USFDA, this procedure is called the Investigational New Drug (IND) application. This video explores the IND application process, and the pharmacology and toxicology enabling studies required to be submitted with the INDA to show that the drug is safe to be tried on humans.

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