IN-VITRO RELEASE TESTING (IVRT)
J. Molner Company teostab IVRT katseid pooltahkete ravimvormide heakskiitmisjärgse muudatuste haldamise protsessi jaoks. Tänu omandatud kogemustele saame edukalt toetada arendust, valideerimist ja võrdlustestimist kogu toote elutsükli vältel – alates arendusest kuni kinnitamiseni ja heakskiitmisjärgsete muudatuste haldamiseni.
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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.
WHY THE J. MOLNER COMPANY
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.
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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.
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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
TEHNIKAD JA METOODIKA
Ettevõttel J. Molner on kvalifitseeritud seadmed IVRT uuringute läbiviimiseks, Immersion (Enhancer) Cell ja Franz Cell (vertikaalne difusioonelement). Järgime FDA Draft Guidance for IVRT, USP <1724>, SUPAC-SS Guidance ja EMA Draft Guideline IVRT arenduses, valideerimises ja võrdlustestimises. Samuti saame pakkuda tuge vanemate IVRT-meetodite optimeerimiseks ja uuesti valideerimiseks, et need oleksid kooskõlas FDA praeguste ootustega (vaata kirjeldust FDA Draft Guidance).