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RegisterIbandronate study [Design Issues]
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.
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
Regards,
MGR
Complete thread:
- Ibandronate study suds4u 2008-05-29 06:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ibandronate study drshiv 2008-07-04 08:52
- Ibandronate study suds4u 2008-07-04 09:23
- Ibandronate studyMGR 2008-07-08 13:06
- Ibandronate study suds4u 2008-07-09 04:55
- Ibandronate studyMGR 2008-07-08 13:06
- Ibandronate study suds4u 2008-07-04 09:23
- Ibandronate study drshiv 2008-07-04 08:52
Ing. Helmut Schütz