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RegisterDonepezil SR 23 mg Tablets BE study [Study Performance]
Dear Mr.Madhav,
FDA recommends to conduct Single dose, two way cross over (both Fasting and Fed studies) in males and non-pregnant females general population for Donepezil. Hence, you can conduct the bioequivalence study in healthy volunteers not in patients with Alzheimer's Disease.
Regards,
Dr.S.Gunasakaran, MD
FDA recommends to conduct Single dose, two way cross over (both Fasting and Fed studies) in males and non-pregnant females general population for Donepezil. Hence, you can conduct the bioequivalence study in healthy volunteers not in patients with Alzheimer's Disease.
Regards,
Dr.S.Gunasakaran, MD
—
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:
- Donepezil SR 23 mg Tablets BE study madhavaraob 2010-07-07 07:27
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- Donepezil SR 23 mg Tablets BE studydrgunasakaran1 2010-07-17 07:23
- Donepezil SR 23 mg Tablets BE study madhavaraob 2010-07-22 09:06
- Donepezil SR 23 mg Tablets BE study Pavidus 2010-07-22 10:09
- Donepezil SR 23 mg Tablets BE study chaitanyag 2010-07-23 05:18
- Donepezil SR 23 mg Tablets BE study Pavidus 2010-07-22 10:09
- Donepezil SR 23 mg Tablets BE study chaitanyag 2010-07-26 14:34
- CROs Helmut 2010-07-26 15:01
- Donepezil SR 23 mg Tablets BE study Dr. Solanki 2010-08-07 10:28
- Donepezil SR 23 mg Tablets BE study Dr. Solanki 2010-08-12 11:30
- Donepezil SR 23 mg Tablets BE study madhavaraob 2010-07-22 09:06
- Donepezil SR 23 mg Tablets BE studydrgunasakaran1 2010-07-17 07:23
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