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Knowledge Gaps and Challenges Facing Development of Orally Inhaled Drug Products

Saluja B, Lee SL.

Respiratory Drug Delivery 2016. Volume 1, 2016: 203-210.

Abstract:

The introduction of quality by design (QbD) into pharmaceutical product development emphasizes understanding how the design of drug products and their manufacturing process impacts the resulting drug product quality. In order to advance regulatory science of orally inhaled drug products (OIDPs), the Food and Drug Administration (FDA) has supported a number of research projects to identify and address some of the knowledge gaps in the development and regulatory evaluation of these complex drug-device combination products. This article summarizes research efforts which are focused on QbD approaches to product development, pharmacokinetics (PK) approaches for establishing bioequivalence (BE), and in vitro and in silico tools for the prediction of in vivo performance. The outcomes of this collaborative body of research are expected to address some of the knowledge gaps and impact FDA policies and standards for evaluation of OIDPs.