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The following message was posted to: PharmPK
Dear Readers
We want to conduct a bio-study of combination product (test product) in
which one drug is of immediate release pattern (20 mg) and another is
sustain release (6 mg) pattern. While reference product is two
different tablets (one is 20 mg IR tablets and one is 2 mg IR tablets).
If we dose 2 mg IR tablet thrice a day against 6 mg SR tablets OD, can
anybody give ideas on how to go for bio-equivalence study, PK
computations and statistical application for in details?
Regards
Mitesh Gandhi
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The following message was posted to: PharmPK
Mitesh,
I assume your main concern is to test BE of 2 mg IR tablet thrice a day
against 6 mg SR tablet OD. Please see the following reference regarding
a
study conducted on extended-release clarithromycin formulation (2X500 mg
q24h versus 500 mg q12h) by the drug sponsor Abbott Laboratories:
Guay DR, Gustavson LE, Devcich KJ, Zhang J, Cao G, Olson CA:
Pharmacokinetics and tolerability of extended-release clarithromycin.
Clin
Ther. 2001 Apr;23(4):566-77
It is also helpful to look at the Clin Pharm section of BIAXIN® XL
Filmtab®
product label.
Regards,
Wei-jian
Wei-Jian Pan, Ph.D.
Clinical Development
Elan Pharmaceuticals
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