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manojkarwa ☆  New Delhi, 2007-10-19 09:18 (6413 d 03:17 ago) Posting: # 1221 Views: 16,312 |
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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 |
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Helmut ★★★  Vienna, Austria, 2007-10-19 16:02 (6412 d 20:32 ago) @ manojkarwa Posting: # 1226 Views: 14,417 |
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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…  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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Nirali ★ India, 2007-10-20 11:07 (6412 d 01:27 ago) @ Helmut Posting: # 1228 Views: 13,560 |
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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 |
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Helmut ★★★ Vienna, Austria, 2007-10-20 15:34 (6411 d 21:01 ago) @ Nirali Posting: # 1229 Views: 13,595 |
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— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Nirali ★ India, 2007-10-24 16:26 (6407 d 20:09 ago) @ Helmut Posting: # 1251 Views: 13,435 |
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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%...  will u pls explain the method how did u calculated 26.3%Nirali |
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Nirali ★ India, 2007-10-25 09:31 (6407 d 03:03 ago) @ Nirali Posting: # 1253 Views: 13,453 |
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Dear HS Finally, I done it !  Thank you. Nirali |
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Helmut ★★★ Vienna, Austria, 2007-10-26 02:43 (6406 d 09:52 ago) @ Nirali Posting: # 1256 Views: 13,500 |
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Dear Nirali! Congratulations & welcome to the club!  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz