Bioequivalence and Bioavailability Forum

kvgreddy06
☆

India,
2013-10-09 15:09
(4641 d 19:36 ago)

Posting: # 11631
Views: 4,711

Discontinuations and Withdrawal [Design Issues]

Hello All

If a drug contain combination of two formulations [IR+ CR] for that drug how can justify the Discontinuation and Withdrawal criteria in case of emesis?

Generally as per guidelines

For IR fomulations we go through as subject experiences emesis within twice the median tmax of X drug after administration of IP.

For CR formulations: subject experiences emesis any time within the labelled dosing interval of the IP

Edit: Category changed. [Helmut]

Helmut ★★★ Vienna, Austria, 2013-10-09 16:28 (4641 d 18:17 ago) @ kvgreddy06 Posting: # 11633 Views: 3,966	IR+CR = MR Post reply
	Hi kvg, a biphasic product (IR+CR) is modified release. Therefore, the dosing interval of the reference is applicable. At least, this is what I employ in my studies. — 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

jag009 ★★★ NJ, 2013-10-13 23:05 (4637 d 11:39 ago) @ Helmut Posting: # 11658 Views: 3,841	IR+CR = MR Post reply
	Hi, Agreed with Helmut. I have been using the dosing interval for CR and IR/CR combination. John

Discontinuations and Withdrawal [Design Issues]

IR+CR = MR

IR+CR = MR