Representative batches? [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2010-08-05 08:40 (4143 d 02:25 ago) – Posting: # 5723
Views: 14,357

Completely agree, HS.
I also occasionally wondered what representative batch actually means, and was preparing to bring the question up during a discussion session at a conference later this year. I imagine it would be OK to think of a repr. batch as one that has some in vitro properties that are close to the means/medians from the distribution of said properties.
The distributions (let's say of dissolution aspects, content) though are never well known at the time of batch selection and if regulators tried to force selection of 'average batches' (pardon my French) as a means of ensuring repr. batches I would imagine many companies would have to give up.

Real life, as I know it works like this: We have X batches of Ref, and Y batches of Test. Now we measure whatever property we consider most likely to correlate with in vivo results and pick the pair that provide the closest match of Test and Ref for that property without in any way having regard to what's typical. I would be tremendously interested in hearing how you bright people out there handle it in practice.

Pass or fail!

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