manojkarwa
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New Delhi,
2007-10-19 07:18

Posting: # 1221
Views: 11,001
 

 Bioequivalence database [Tips / Tricks]

Dear Group members,

I wanted to know that is there any database of bioequivalence studies conducted in different countries till now other than published literature where one can get the basic design and analytical parameters of any formulation bioequivalence.

Regards
Manoj Karwa

Manoj Karwa,
Project Manager,
Auriga Research Limited,
3/15, Kirti Nagar Industrial Area,
New Delhi-110015
Phone 011-45072314
Helmut
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Vienna, Austria,
2007-10-19 14:02

@ manojkarwa
Posting: # 1226
Views: 9,928
 

 Bioequivalence database

Dear Manoj!

» … is there any database of bioequivalence studies conducted in different countries till now other than published literature where one can get the basic design and analytical parameters of any formulation bioequivalence.

Oh, we all want to have that one… :cool:
You my get filed applications under the 'Freedom of Information Act' from the FDA, or search UK's MHRA.
If you are lucky, intra-subject CVs are included; but you may calculate them from the confidence interval as well. Details of the analytical method(s) are always ██████████.
Recommendations for (some) individual products are also available from the FDA.

Cheers,
Helmut Schütz
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Nirali
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India,
2007-10-20 09:07

@ Helmut
Posting: # 1228
Views: 9,194
 

 Bioequivalence database

Dear HS
can you please guide me in how to calculate the Intrasubject CV from confidence interval as you have stated in the post.
Regards
Nirali
Helmut
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Vienna, Austria,
2007-10-20 13:34

@ Nirali
Posting: # 1229
Views: 9,205
 

 CV-intra calculation from CI

Dear Nirali!

Please see this post.
Solace: highschool-math would do the job...

Cheers,
Helmut Schütz
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Nirali
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India,
2007-10-24 14:26

@ Helmut
Posting: # 1251
Views: 9,099
 

 CV-intra calculation from CI

Dear HS

» Please see this post.
» Solace: highschool-math would do the job...

above reference link represents an example i.e.--- if the CI is given as 89.0%-115% (n=24), you will get the CV also to three significant digits as 26.3%

I tried a lot but not getting 26.3%... :no: will u pls explain the method how did u calculated 26.3%

Nirali
Nirali
★    

India,
2007-10-25 07:31

@ Nirali
Posting: # 1253
Views: 9,062
 

 CV-intra calculation from CI

Dear HS

Finally, I done it ! :ok:

Thank you.
Nirali
Helmut
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Vienna, Austria,
2007-10-26 00:43

@ Nirali
Posting: # 1256
Views: 9,112
 

 CV-intra calculation from CI

Dear Nirali!

Congratulations & welcome to the club! :-D

Cheers,
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. ☼
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