inter-batch variability? [Regulatives / Guidelines]

posted by Pavidus – 2010-08-04 11:57 (4344 d 05:05 ago) – Posting: # 5714
Views: 14,472

Dear Dr_Dan & all,

Allow me one general remark:
IMHO BE studies are definitely not suitable to assess inter-batch variability of any product.

I am not saying, that this remark will "save" your product .... discussion with 'assessors' is always difficult... :-(

(btw. nice figures for a highly-variable drug)

Kind regards, P.

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