swapnil.kuche
★    

2011-08-04 11:22
(5444 d 00:31 ago)

Posting: # 7257
Views: 4,161
 

 IVIVC [Regulatives / Guidelines]

Dear All,

Please comment on following queries regarding IVIVC

1) Is it required to conduct IVIVC for all modified relese drug product if drug product complies with BCS requirement for IVIVC? Please explain in which scenario we have to condduct IVIVC?

2) What is requirement of slow, medium and fast release formulation in IVIVC? Which type of corelation is this?

3) Please explian me in which type of formulation following metrices will be evaluated and why?
i) Cmax/AUC
ii)MRT
iii)POT-25, T75%
iv) HVD, POT-50
v)%PTF
vi)%Swing
vii)%AUCF
viii) T75%
ix)Partial AUC

Regards,
Swapnil D. Kuche
swapnil.kuche
★    

2011-08-05 12:41
(5442 d 23:11 ago)

@ swapnil.kuche
Posting: # 7265
Views: 3,475
 

 IVIVC

Dear All,

Please comment on my above query at earliset if possible

Regards,
Swapnil D. Kuche
Helmut
★★★
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Homepage
Vienna, Austria,
2011-08-05 12:51
(5442 d 23:01 ago)

@ swapnil.kuche
Posting: # 7266
Views: 3,469
 

 Politeness

Dear Swapnil!

❝ Please comment on my above query at earliset if possible


Please follow the Forum’s Policy! We are posting here in our freetime, and if someone asks me to answer ‘at earliest as possible’, I’m definitely not in the mood for doing so at all. :sleeping:

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swapnil.kuche
★    

2011-08-05 13:01
(5442 d 22:52 ago)

@ Helmut
Posting: # 7267
Views: 3,453
 

 Politeness

Dear HS

Sincere apologise if anyone find my language rude. Anyways i will take care for the same in future.

By the way

❝ at earliest as possible’


Actually it is 'at earliest if possible’

Regards,
Swapnil
yjlee168
★★★
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Homepage
Kaohsiung, Taiwan,
2011-08-05 16:35
(5442 d 19:17 ago)

@ swapnil.kuche
Posting: # 7270
Views: 3,458
 

 IVIVC

Dear Swapnil,

There have been a lots of posts or pointers discussed in this Forum about your questions. Please use "Search" function on the upper right corner with key words such as ivivc, in-vitro in-vivo, etc.. You will find the answers from searched results, particularly this post by Helmut. That's what I do. Also, you may need a textbook about ivivc, e.g. this one. You also can Google it. Hope this can help.

All the best,
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