Topics: CLPT, M.Pharmacy, Pharmaceutics; Regulatory Affairs Quiz
IMPD should contain nonclinical pharmacology and toxicology data including summaries of nonclinical pharmacology and toxicology data for any IMP to be used in the clinical trial or justify why they have not.
A. TRUE
B. FALSE
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The IMPD should also provide data from nonclinical trials and any information on the previous clinical use of the IMP or justify in the application why information is not provided.
A. TRUE
B. FALSE