IN-VITRO RELEASE TESTING (IVRT)
The J. Molner Company is performing IVRT studies for post-approval change management process for semisolid dosage forms. Thanks to the experience obtained we can successfully support development, validation, and comparative testing throughout product lifecycle - from development to approval and managing post-approval changes.
IN-VITRO RELEASE TESTING
An in vitro release test (IVRT) has become a valuable tool and, in many cases, a regulatory requirement for demonstrating bioequivalence in new generic drugs, ensuring product quality, and obtaining approval for changes in approved ANDAs.
Bioequivalence demonstration following Product Specific Guidance provides information the FDA expects to be submitted in an ANDA to support bioequivalence and often IVRT is included. It is also meaningful to provide IVRT comparison data between company’s own product and RLD/RS (reference listed drug/reference standard) in comparative study report even if it is not required in product-specific guidance to support the development outcome and increase FDA reviewer’s confidence in the submitted dossier.
SUPAC-SS FDA Guidance provides information for which changes in approved ANDAs IVRT test data should be submitted to FDA to provide evidence that product quality and bioavailability were not affected due to alterations in formulation, process, or manufacturing site.
IVRT at the J. Molner Company
TECHNIQUES AND METHODOLOGY
The J. Molner Company has qualified equipment to perform IVRT studies using Immersion (Enhancer) Cell and Vertical Diffusion Cell (Franz Cell) equipment. Our procedures for development, validation and comparative testing follow FDA Draft Guidance for IVRT, USP <1724>, SUPAC-SS Guidance and EMA Draft Guideline. Our quality management system is in compliance with GLP and GMP requirements. We can also provide support to optimize and re-validate older IVRT methods so that these are in agreement with current FDA expectations as described in the FDA Draft Guidance.
WHY THE J. MOLNER COMPANY
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Trained and highly motivated team with years of experience
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Competitive pricing compared to companies located in the US
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Inspected and European Union GMP certified laboratory (inspected by local regulatory body whose inspections are recognized by US FDA due to Mutual Recognition Agreement – see Mutual Recognition Agreement (MRA) | FDA)
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Quick turnaround times for projects with time-sensitive deadlines.
