Bioequivalence and Bioavailability Forum

aanrin ☆ United Arab Emirates, 2015-07-28 10:43 (3188 d 22:59 ago) Posting: # 15160 Views: 2,709	Tamsulosine Hydrochloride [Regulatives / Guidelines] Post reply
	Dear Sir/ madam What is the recommendation by the european medical agencies, TGA, USFDA for conducting BE study for Tamsulosine Hydrochloride. Only fed Study should be conducted and submitted if the molecule is having effects on Food? Will they accept only Fed study? Please advice me for the same. With regards Aan

Anand
☆

India,
2015-07-28 15:55
(3188 d 17:47 ago)

@ aanrin
Posting: # 15163
Views: 2,239

Tamsulosine Hydrochloride

Post reply

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]

Tamsulosine Hydrochloride [Regulatives / Guidelines]

Tamsulosine Hydrochloride