Tamsulosine Hydrochloride [Regulatives / Guidelines]

posted by Anand – India, 2015-07-28 15:55 (3491 d 05:16 ago) – Posting: # 15163
Views: 2,545

Dear Aan,

For USFDA – Fast & Fed BE Study required (as per OGD Individual product bio-equivalence recommendation).

For EU & TGA – Fed BE study required (as per EMEA guideline). Please specify the dosage form for more clarification in future.

Regards,
A.Anand
Bio-PK
India

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! [Helmut]

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