If it is important to have Discriminatory Dissolution method for IVIVC, what should be done in case drug release is independent of test conditions?
SD: When the formulation release is independent of dissolution test conditions (e.g., osmotic pump formulations) the best approach is to design 2 or 3 formulations that release drug over different intervals, e.g., develop a 10, 12 & 14 h release test formulations & perform the necessary in vivo biostudy & IVIVC analyses. Alternatively, one may develop an IVIVC based on one formulation, but the value of such an IVIVC will depend on the regulatory agencies reviewing the IVIVC. 50.Your presentation says that if internal validations for IVIVC test fails, then test for external validation. In my opinion one should analyze why internal Validation fails and should not proceed for external validation UNLESS internal Validation is through. Please comment. SD: You are absolutely right. One must always try to first analyze the reasons for failure of internal validation (formulation, dissolution method, IVIVC formula & calculation methods, etc) & try to address these issues first. However, the FDA
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