BE study with two different batches of the reference product [Study As­sess­ment]

posted by cher0424 – China, 2014-12-16 10:31 (4209 d 03:49 ago) – Posting: # 14080
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(edited on 2014-12-16 11:04)

Hello ElMaestro:
It indeed haven't prepare well for the trial, but the different between two batch should be within 5%, so particularly no much influence in trial result. Unless the test product quality happen on the edge of 80%-125%. In that case the differences between two batch are essential to pass or fail.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

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