Setting clinically relevant tolerances for dissolution testing: A simple and practical alternative

The in vitro drug dissolution tests, or simply dissolution tests, are conducted to evaluate potential drug release characteristics of a product in vivo or in the GI (gastrointestinal) tract. This in vivo dissolution is indirectly measured based on the observed plasma drug levels or profiles in humans. The drug levels in plasma provide the therapeutic (or toxic) effects thus representing the clinical outcome. Equal or similar drug levels in plasma are considered to provide equal or similar therapeutic effects and vice versa. Therefore, to have clinically relevant dissolution tolerances, dissolution results are to be linked to plasma drug levels. Please click here for complete article

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