mvgchakravarthi
☆    

India,
2009-09-10 19:25
(6127 d 14:55 ago)

Posting: # 4185
Views: 5,650
 

 Extended release dosage forms [Dissolution / BCS / IVIVC]

Post reply
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
(6122 d 00:54 ago)

@ mvgchakravarthi
Posting: # 4209
Views: 4,430
 

 Extended release dosage forms

Post reply

❝ 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
(6120 d 19:24 ago)

@ kaushalesh
Posting: # 4210
Views: 4,369
 

 Extended release dosage forms

Post reply
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]
 
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
137 visitors (0 registered, 137 guests [including 13 identified bots]).
Forum time: 10:21 CEST (Europe/Vienna)

Science is simply common sense at its best that is,
rigidly accurate in observation, and
merciless to fallacy in logic.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5