Excipients in generic drug products are evaluated from clinical and nonclinical perspectives to ensure that they do not alter the safety profile of the formulation as compared to the Reference Listed Drug.
FDA Pharmacology/Toxicology Review of the proposed level of an excipient includes an evaluation of toxicology data to support the dose, route of administration, duration of exposure and patient population.
Subject area:
Excipients
Objectives (If applicable):
N/A
Target Audience (If applicable):