Strategies for the Equivalence Assessment of Locally Acting Complex Drug Products: Focus on Alternative Methodologies

Published in the AAPS Journal 2015
The authors would like to thank Charles DiLiberti; Yu Chung Tsang, Ph.D.; Raja Velagapudi, Ph.D.; Murray Ducharme, Pharm.D.; Barbara Davit, Ph.D.; steering committee members
of the AAPS Generic Pharmaceuticals and Bioequivalence focus groups; and the leadership of the AAPS Regulatory Sciences section for their insights and review, which contributed greatly to this article.
Learn more about the AAPS Regulatory Sciences section; visit the section’s webpage at
Complex drug products (CDPs) comprise a growing pharmaceutical sector, due to the safety, efficacy, and compliance benefits they provide. CDPs include those with complex active ingredients (e.g., peptides, natural source products), complex formulations (e.g., liposomes, iron colloids), complex routes of delivery (e.g., locally acting drugs), and drug-device combinations (e.g., inhalers, nasal sprays, auto injectors, and transdermal systems).1 As reflected in recent regulatory science initiatives by the Food and Drug Administration (FDA),2 there is a rising interest in making generic versions available for all CDP categories by applying a rational, science-driven approach that conceptually relies on quality by design. The current article discusses an integrated and dynamic methodology, centered on nonclinical techniques, for optimizing formulations and accelerating equivalence assurance of locally acting drug products, a subset of CDPs….
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