Analytical Strategies from Early Development to Validation

Analytical chemists develop test methods and control strategies to guide process chemists who are developing, optimizing, and scaling up drug substance manufacturing. Analytical methods also guide formulation scientists who are developing drug product dosage forms. These analytical procedures are necessary to ensure the identity, strength, quality, purity, and potency of each drug substance and drug product manufactured for human use. This presentation will provide analytical strategies to support CMC drug development from the preclinical phase to commercial production, with a focus on drug substance programs.