Bioequivalence and Bioavailability Forum • Dose for BE Studies

hiren379
★

India,
2012-10-06 08:01
(5013 d 13:19 ago)

Posting: # 9327
Views: 3,137

Dose for BE Studies [Design Issues]

Hello All...
Can anyone through some light on below issue

e.g A drug (Reference) is available at maximum strength of 50mg tablet. But the prescribing information says that minimum therapeutic dose is 200 mg i.e 4*50 mg tablet.

Then at what dose one should assess BE for such drug? single tablet (50 mg dose) or 4 tablets (200mg dose).
Note: Please note that there are no analytical issues. PK can be well characterised with single dose also.

OGD sometimes recommends to do BE at therapeutic dose (4 tablets)
e.g Balsalazide.
However for Mesalamine even though therapeutic dose is higher than maximum strength they have not recommended to assess BE at therapeutic dose. :confused:

Please guide...

Thanks

jag009 ★★★ NJ, 2012-10-08 20:12 (5011 d 01:08 ago) (edited on 2012-10-08 20:40) @ hiren379 Posting: # 9340 Views: 2,441	Dose for BE Studies Post reply
	Hi Hiren, No BE guidance on this drug at FDA website? Usually BE studies are done at highest strength of the formulation unless there are safety issues (ie: BE for Wellbutrin XL is at 150 mg. 300 mg strength tablets are not studied due to safety issues). John

cakhatri ★ India, 2012-10-09 09:31 (5010 d 11:49 ago) (edited on 2012-10-09 10:07) @ hiren379 Posting: # 9348 Views: 2,443	Dose for BE Studies Post reply
	Hi Hiren, I suggest you seek advice from FDA by contacting them on the following mail ID CDERSmallBusiness fda.hhs.gov. I asked for clarification on investigational product and their response was very quick. Regards Chirag Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]