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say, with the process analytical technology to essentially do a test for an entire manufacturing product lot non-destructively, the USP-type specification is not conducive to that sort of an assessment.  So you really have to take the next evolutionary step and bring a sound statistically based approach to doing that assessment and you'll hear that proposal after my presentation today.

I think one of the challenges there is there are two issues being discussed with that proposal.  One is moving towards the parametric tolerance interval criteria. ‑‑ and you'll have a much in-depth discussion at a subsequent meeting ‑‑ think of that as two areas, moving towards the parametric tolerance interval and then establishing what are the acceptance criteria.

The other presentation we'll have today is on endogenous substances, bioavailability and bioequivalence of that, and we discussed this yesterday, also.  I think many issues remain unresolved with respect to bioavailability/bioequivalence, many are perception issues, many are scientific issues.  And I think the Biopharmaceutics Subcommittee will have to prioritize and

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