A-M-R
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Egypt,
2013-04-14 16:11
(4819 d 10:02 ago)

Posting: # 10409
Views: 4,351
 

 Amlodipine bioequivalence for 10 mg tablets [Regulatives / Guidelines]

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Request

Want to know the necessity to do bioequivalence study for amlodipine besylate 10 mg tablets as i know that amlodipine besylate 5 mg tablets is assigned to BCS class I according to WHO essential list of medicines.
very thanks
Amr hussein
 
drgunasakaran1
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2013-04-14 16:44
(4819 d 09:29 ago)

@ A-M-R
Posting: # 10410
Views: 3,669
 

 Amlodipine bioequivalence for 10 mg tablets

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Dear Mr Amr Hussein,
Which country of submission.?
If it is for US FDA, you need to conduct both fasting and fed studies with 10 mg strength.
—
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
 
A-M-R
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Egypt,
2013-04-15 10:40
(4818 d 15:34 ago)

@ drgunasakaran1
Posting: # 10415
Views: 3,640
 

 Amlodipine bioequivalence for 10 mg tablets

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Dear Sir,
The study will be introduced for local regulatory authorities.
Thanks
Amr Hussein
 
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