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The TissUse products are actually being used at the NCTR within the FDA!

For more details, please refer to the related links or feel free to contact us.

It is possible to evaluate elution and membrane permeability simultaneously with a small volume!

* Achieving solubility measurement with a small sample By connecting to Rainbow, in-situ UV measurements can be performed without sampling, enabling solubility measurements with small volumes. This allows for solubility measurements without losing valuable APIs in the early stages. * Evaluation of supersaturation duration is possible By connecting to Rainbow, it is also possible to evaluate supersaturation. Real-time concentration detection makes it easy to assess the duration of supersaturation. * Obtaining data with high correlation to PK data Results from testing different formulations of APIs with µFLUX have shown a significant correlation between the concentration in the µFLUX acceptor chamber during animal experiments and the AUC of the plasma concentration profile, compared to published PK data. * Evaluation of Food Effect By changing the test solution used on the donor side to FaSSIF or FeSSIF, it is possible to validate the Food Effect.

Dissolution and membrane permeability can be evaluated simultaneously in the final dosage form! It is also used for predicting biological equivalence tests!

* Evaluation of Drug-Drug Interactions After the start of the trial, there are many instances of tests where FaSSIF or FeSSIF is dripped in to shift the pH after a certain period of time. By conducting tests under varying conditions, such as from the normal gastric acid pH and from low gastric acid pH, there is also evidence of verification of drug-drug interactions. * Evaluation of Food Effect By changing the test solution used on the donor side to FaSSIF or FeSSIF, it is possible to verify the Food Effect. * Comparison of Brand-name and Generic Products Tests are conducted under the same conditions as the target brand-name product, and there is evidence that the results have been used for predicting bioavailability (BA). * In China, there are cases where Macro/BioFLUX data has been utilized for exemptions from human bioequivalence testing (bio waivers).