Strategies for Biowaiver Application for Generic Nasal Sprays

Authors & ContributorsDavid Exline

October 27, 2016

The active pharmaceutical ingredient (API) size distribution within the final formulation of a drug product is critical as it relates to bioavailability, rates of absorption, and stability of that drug product. Gaining an understanding of the API particle size distribution (PSD) is becoming of greater importance to regulatory agencies, particularly as they relate to the Critical Path Opportunity and biowaiver applications. In fact, a successful ANDA application for mometasone furoate nasal spray utilized Raman spectroscopy as an in vitro study technology in lieu of repeating a clinical endpoint study.

In this webinar, Gateway Analytical will highlight techniques using Raman spectroscopy for abbreviated new drug applications (ANDA) with FDA. Next Breath will present an overview of in vitro bioequivalence requirements and approaches incorporating this new technique.

Analysis using automated Raman technology that combines optical microscopy and Raman spectroscopy will be described. Interpretation of single and agglomerated particles sizes will be presented. In addition, the pros and cons of various instrument approaches will be highlighted. The webinar will conclude with an overview of Gateway’s and Next Breath’s combined strategy for establishing in vitro bioequivalence for regulatory submissions.

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