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RegisterExpedited review from IEC [Regulatives / Guidelines]
Dear Mr Vivekanand,
You need to go for Full Board IEC Review if the Sponsor changes since the test formulation of this new sponsor may not have the same safety profile of another sponsor's test formulation.
No. You need to go for Full Board IEC Review for the above scenario.
❝ I. Can we proceed for expedited review of BA/BE study for the Drug which remains same(few are listed below) in all aspects of the study design except change in sponsor.
You need to go for Full Board IEC Review if the Sponsor changes since the test formulation of this new sponsor may not have the same safety profile of another sponsor's test formulation.
❝ II. IF their is change in blood loss for BA/BE study of same drug with different sponsor can we proceed for expedited review.
No. You need to go for Full Board IEC Review for the above scenario.
—
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:
- Expedited review from IEC vivekanand 2012-09-26 06:55
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- Expedited review from IECdrgunasakaran1 2012-09-26 09:14
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