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Clinical pharmacology may also involve comparative bioavailability analyses, which are generally required for drug formulation bridging studies, to demonstrate bioequivalence. These are put in place to ensure product quality in compliance with FDA requirements. Clinical Pharmacology. Clinical Safety and Efficacy.
Nonclinical programs include (but are not limited to) method development and validation, pharmacokinetic studies, in vivo efficacy studies, safety pharmacology, IND-enabling toxicology studies, and long-term studies when appropriate. Overview of Drug Development Programs (Through IND Submission). Expensive starting materials.
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