Topics: CLPT, M.Pharmacy, Pharmaceutics; Regulatory Affairs Quiz
‘IB’ do not contain Physical, Chemical, and Pharmaceutical Properties and Formulation, details.
A. TRUE
B. FALSE
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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