LOGO-Gateway-Analytical.png

The Particle Articles

Helping Generic Manufacturers Prove Bioequivalence of Suspension Nasal Sprays

[fa icon="calendar'] Apr 20, 2012 10:30:45 AM / by David Exline posted in analytical testing, aqueous suspension formulations, bioequivalence, Blog, critical path opportunities, FDA, in vitro, in vivo, Nasal Drug Products, Nasal suspension PSD, Pharmaceutical, pharmaceutical, pharmaceutical formulation, suspension nasal sprays

[fa icon="comment"] 0 Comments

In 2004, the FDA launched the Critical Path Initiative as a national strategy to drive innovation in development, evaluation and manufacturing of medical products1.  As part of this initiative, the FDA identified a number of Critical Path Opportunities (CPOs) for generic drugs.  Namely the CPO for Bioequivalence of Nasal Sprays, which identifies a need for direct measurement of particle size equivalence in suspension nasal sprays2.

Read More [fa icon="long-arrow-right"]

Subscribe to Email Updates

Lists by Topic

see all

Posts by Topic

see all

Recent Posts