Bracketing Applied to Annual Stability Program

[Walter Routh]

#24883

Posted on behalf of Raphy Bar:

Can bracketing approaches be applied to annual stability storage programs?

Example: With a solid dosage product at 80, 40, and 20mg strengths with identical formulation, could one put just one strength, say 80mg, on annual stability this year and 20mg next year, and so on?

[John O’Neill]

#24891

I’ve not heard of bracketing being applied at this level, but in theory, it could be, depending upon the responses first of corporate quality and regulatory groups and then officially, the outcome of a request to the regulatory authorities to apply bracketing to annual batches.

[Author]

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