Working to Address the FDA Critical Path Opportunity for Generic Nasal Spray Suspensions

    The FDA stated in their 2007 Critical Path Opportunity for Generic Drugs that “If the drug particle size distribution of test and reference products can be demonstrated to be equivalent, then nasal spray suspensions could be treated like nasal spray solutions. The critical path opportunity is to develop methods to measure drug particle size in a suspension product with sufficient accuracy and precision so that in vivo biostudies can be waived.”

    This webinar was designed for generic drug manufacturers of nasal spray suspensions. During this webinar, our presenters discussed how the method of  Ingredient-Specific Particle Sizing (ISPS) using Raman Chemical Imaging (RCI) developed by Gateway Analytical, can address the critical path opportunity by providing the accurate and precise drug particle size measurement to demonstrate bioequivalence. This service offering has the potential to save considerable time and money for generic nasal spray suspension developers if in vivo biostudies are waived.

    The presenters also provided information on Gateway Analytical’s process for addressing the critical path opportunity; outlining the development of the feasibility study, writing and implementing the validation protocol, and the sample size needed for analysis as required by the FDA. The importance of using a cGMP certified lab for quality control and assurance was also be discussed.

    Highlighted Topics Covered:

    • What the FDA critical path opportunity is for generic nasal spray suspensions
    • How Gateway Analytical’s method for drug particle sizing can address this critical path opportunity
    • Why this service has the potential to save generic drug manufacturers a considerable amount of time and money
    • Provide information on Gateway Analytical’s process for addressing the critical path opportunity
    • The importance of using a cGMP certified lab for quality control and assurance