Bioequivalence and Bioavailability Forum • Fasting study variability

PTM139
☆

India,
2012-05-29 11:41
(5137 d 23:31 ago)

Posting: # 8622
Views: 3,158

Fasting study variability [Design Issues]

Dear HS,

We are having the data of fasting and fed study for few of the HVDs. The trend which we are observing is there is less variability in fed state but high variability in the fasting state. Now my question is "What are the precautions to be taken during protocol designing for bioequivalence studies?"

Edit: Please don’t address posts to me personally – there are many other competent members in the forum as well. ;-)

[Helmut]

drgunasakaran1
★★

2012-05-29 12:27
(5137 d 22:45 ago)

@ PTM139
Posting: # 8625
Views: 2,423

Fasting study variability

Post reply

Dear Mr PTM139,

The Fasting study protocol can be designed as Replicate one with scaling in case of FDA and Expandable BE limits in case of EMA submission if the drug shows high variability in the Fasting state.

The Fed study protocol can be designed as Two way, two period, cross over study for both FDA and EMA if the drug shows less variable in the Fed state.

—
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