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suds4u ☆ India, 2008-05-29 08:09 (6607 d 17:08 ago) (edited on 2008-05-29 11:09) Posting: # 1880 Views: 4,625 |
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Hi, is there any literature available on Ibandronate biostudy in healthy volunteers Regards Dr.Sudhee -- Edit: category changed [Jaime] |
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drshiv ★ India, 2008-07-04 10:52 (6571 d 14:24 ago) @ suds4u Posting: # 1993 Views: 3,749 |
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Hi Suds4u, We have experience in ibandronate study. What do you like to know about this. Dr. Shiv |
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suds4u ☆ India, 2008-07-04 11:23 (6571 d 13:54 ago) (edited on 2008-07-04 12:17) @ drshiv Posting: # 1994 Views: 3,757 |
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Dear Dr. Shiv Can you provide some details like whether the study was done on healthy volunteers, possible sample size, etc. Also can you provide any published literature or reference Ibandronate. Regards Suds4u -- Edit: Full quote removed. Please see this post! [Jaime] |
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MGR ★ India, 2008-07-08 15:06 (6567 d 10:11 ago) @ suds4u Posting: # 2004 Views: 4,778 |
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Dear Dr.Sudhee, The following link may help you, http://www.fda.gov/cder/foi/nda/2003/21-455_Boniva.htm In the above link you can find the documents (especially in clinical Biopharmaceutics) contains the Reference drug conducted studies, intrasubject CV, etc... the following link are the recommendations from the USFDA to conduct the study: http://www.fda.gov/cder/guidance/bioequivalence/recommendations/Ibandronate_tab_21455_RC11-06.pdf We have conducted the study as a pilot study with 18 subjects. — Regards, MGR |
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suds4u ☆ India, 2008-07-09 06:55 (6566 d 18:21 ago) (edited on 2008-07-09 10:22) @ MGR Posting: # 2007 Views: 3,585 |
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Dear MGR Thanks for the reply Regards Sudhee -- Edit: Full quote removed. Please see this post! [Ohlbe] |
Ing. Helmut Schütz