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RegisterFasting study variability [Design Issues]
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.
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
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
Complete thread:
- Fasting study variability PTM139 2012-05-29 09:41
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- Fasting study variabilitydrgunasakaran1 2012-05-29 10:27
Ing. Helmut Schütz