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Clinically Relevant Specifications for Orally Inhaled Drug Products: Challenges and Opportunities

Delvadia RR, Suarez Sharp S, Mandula H, Bertha CM, Pinto J, Paluvuri V.

Respiratory Drug Delivery 2020. Volume 1, 2020: 123-130.


Pharmaceutical quality assures that every dose is safe and effective, free of contamination and defects. Drug product specifications play a critical role in ensuring that commercial batches have consistent safety and efficacy profiles to those used in clinical studies. Advancements in clinically relevant in vitro methods and in silico tools have significantly improved our understanding of how variation in critical quality attributes (CQAs) would impact clinical performance of orally inhaled drug products (OIDPs). Industry could leverage such learning while setting clinically relevant drug product specifications (CRDPS) to help justify process or product changes that may occur during development or after the approval. CRDPS can offer significant advantages over conventional quality control (QC) tests by enabling, for example, device, formulation, and process control without under or over discrimination with the possibility for regulatory flexibility (e.g. implementation of certain manufacturing process and product changes without the need for conducting additional clinical studies). This abstract looks into current challenges and potential opportunities for the implementation of CRDPS for OIDPs, with focus on dry powder inhalers (DPIs) and metered dose inhalers (MDIs).

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