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Dear All,
Greetings,
Please let me know , does anybody had an experience of conducting the
relative BA study of Biophosponates for example Alendronate.
Regards:
Shaikh Feroz Ibrahim
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The following message was posted to: PharmPK
Dear Ibrahim,
We have experience in conducting Bioequivalence studies with Alendronate
for various submissions such as FDA, EU etc.
The peculiarities with Alendronate are, we have to collect urine samples
for analysis, since the method available is with urine only and that too
only very few analytical facilities have the method (like Anapharm
Canada). The other one is, it needs a large sample size because of its
high ISCV (we have conducted studies with 100 subjects).
And also be prepared for AEs, particularly myalgia.
Otherwise it is relatively a simple study.
Any additional information from other members will be appreciated.
Regards,
Joseph
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The following message was posted to: PharmPK
Dear Shaikh,
MDS Pharma Services has experience with Alendronate and we have
developed analytical methods for both plasma and urine (at Lincoln,
Nebraska). With plasma samples, a smaller number of subjects than urine
have to be enrolled for bioequivalence study.
Regards,
Jean
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The following message was posted to: PharmPK
Dear Ibrahim,
We have experience too in conducting Bioequivalence studies with
Alendronate for submissions to SA, GCCH and other Gulf States to
various drug companies. we have to collect urine samples for analysis
and it needs a large sample size because of its high ISCV but we
conducted studies with only 40% of the number reported by Dr. Joseph
(40 subjects) and the results were accepted by the authorities
without any reservation.Best regard and Good luck,
Professor Khalil I M Al-Khamis, Ph.D
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