mvgchakravarthi
☆    

India,
2009-09-10 19:25
(6135 d 10:51 ago)

Posting: # 4185
Views: 5,682
 

 Extended release dosage forms [Dissolution / BCS / IVIVC]

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Dear all

kindly give your suggestions for following question

In case of Extended release dosage forms, is it compulsory to submit dissolution profiles in pH range from 1.0 to 6.8 to US/EU?

Regards
M.V.G.Chakravarthi
 
kaushalesh
☆    

2009-09-16 09:26
(6129 d 20:50 ago)

@ mvgchakravarthi
Posting: # 4209
Views: 4,464
 

 Extended release dosage forms

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❝ In case of Extended release dosage forms, is it compulsory to submit dissolution profiles in pH range from 1.0 to 6.8 to US/EU?


Yes. multi media dissolution is compulsory for all ER products for both the markets

Regards
:-)
 
mvgchakravarthi
☆    

India,
2009-09-17 14:56
(6128 d 15:20 ago)

@ kaushalesh
Posting: # 4210
Views: 4,401
 

 Extended release dosage forms

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Thanks for ur response.
Regards
M.V.G.Chakravarthi

--
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]
 
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