Bioequivalence and Bioavailability Forum

Tina ★ India, 2013-10-03 20:15 (4646 d 09:41 ago) Posting: # 11604 Views: 8,461	Washout period-5 or 10 halflives [Regulatives / Guidelines] Post reply
	Dear forum members, I have a very simple question to ask regarding the washout period. While selecting the washout period for crossover BE study, are we required to select a period of 5 half lives or 10? 5 halflives would mean that 3.1% is remaining while 10 half lives would mean that 0.09% is remaining. Kind regards, Tina

jag009 ★★★ NJ, 2013-10-04 00:28 (4646 d 05:28 ago) @ Tina Posting: # 11607 Views: 7,275	Washout period-5 or 10 halflives Post reply
	Hi, Most use 5 half-lives, 10 is a bit of an overkill. Note that when you use a literature mean half-life to set up your study washout, it is advisable to take the standard deviation into account. John

drgunasakaran1
★★

2013-10-04 05:29
(4646 d 00:27 ago)

@ Tina
Posting: # 11608
Views: 7,247

Washout period-5 or 10 halflives

Post reply

Dear Tina,

❝ While selecting the washout period for crossover BE study, are we required to select a period of 5 half lives or 10? :confused:

For which regulatory, are you planning to submit your BE study.
For Canada, the minimum time between treatments should be the same for all subjects and, to account for variability in elimination rate between subjects, normally should be not less than 10 times the mean terminal half-life of the drug.
For FDA, an adequate washout period (e.g., more than 5 half lives of the moieties to be measured) would separate each treatment.
For ANVISA, the interval between the periods shall be of at least seven half-lives of the active ingredient and/or metabolite elimination.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Tina ★ India, 2013-10-07 14:03 (4642 d 15:53 ago) @ drgunasakaran1 Posting: # 11615 Views: 6,827	Washout period-5 or 10 halflives Post reply
	Dear drgunasakaran1, What are the washout period requirements uin the EU and Australia? Are there any difference in requirement within the EU countries? Kind regards, Tina