Bioequivalence and Bioavailability Forum

rahul_hi1234 ● 2007-04-26 12:44 (7005 d 11:15 ago) Posting: # 695 Views: 4,166	for Dosing [Regulatives / Guidelines] Post reply
	I WANT TO ASK HS WHY WE ARE NOT DOING THE BA/BE FOR MULTI DOSE STUDY GENARALLY WE ARE DOING FOR THE SINGLE DOSE STUDY IS THERE ANY SPECIFIC REGULATORY REQIREMENT TO CONDUCT MULTI DOSE STUDY PLEASE GUIDE ME

Helmut
★★★

Vienna, Austria,
2007-04-26 14:06
(7005 d 09:53 ago)

@ rahul_hi1234
Posting: # 696
Views: 3,528

single dose vs. multiple dose

Dear rahul!

Don’t post in upper case letters (see the Policy of the Forum and Hermann’s reply to another post of yours)!
Give a specific Subject line; “for Dosing” is meaningless.
= 1 + 2 + looking at your previous posts: I’m getting the impression you’re a Troll…
Single dose studies have more discriminatory power in detecting differences than multiple dose studies (especially for the rate of BA).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

shankar ★ India, 2007-06-11 07:53 (6959 d 16:06 ago) @ rahul_hi1234 Posting: # 794 Views: 3,304	for Dosing Post reply
	DearRahul, BA/BE studies are recommended in single dose (highest avilable strength)for immediate release products. For controlled release products multiple dose steady state study recommended. Please refer CPMP guidelines: http://www.emea.europa.eu/pdfs/human/ewp/028096en.pdf Shankar NJ