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///Nasal Spray Bioequivalence – In Vitro Test Study Plan

Nasal Spray Bioequivalence – In Vitro Test Study Plan

About this Chemistry, Manufacturing and Controls Documentation

Next Breath is a full service cGMP compliant laboratory for analytical testing of nasal spray drug products to support your ANDA submission. Using the study design in this document for a model suspension nasal spray product, Next Breath will customize a program to meet your requirements, conduct the relevant experiments according to the Draft Guidance for Industry: Bioavailability and Bioequivalence of Nasal Aerosols and Nasal Sprays for Local Action, interpret the test results and generate a report suitable for inclusion in your regulatory submission.

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2017-11-19T01:16:06+00:00