May I respectfully invite your comments and suggestions on our plan toBack to the Top
conduct BA/BE on our modified release anti-diabetic formulation. Our
company is developing another Anti-Diabetic Modified Release
GLICLAZIDE, in 2 dosage strength tablet formats, 30 mg and 60 mg. We
compare the BA/BE of these 2 formats versus the reference product
(innovator brand). The dose to be administered will be 60 mg, single,
(1 x 60 mg / 2 x 30 mg tablets).
Question : The innovator brand is available only in 1 strength (30 mg
Is the innovator brand 30 mg tablet format appropriate also to use as
reference product for the generic 60 mg tablet format? Would there be
great difference in the results (absorption and elimination profiles)
for th 30 mg format, we will dose 2 tablets versus 1 tablet for the 60
I understand, for bioequivalence, strictly speaking, the comparison
be that of 2 products of the same active ingredient, same dosage
and format and should be done on the highest dosage strength of the
Thank you so much for your very valuable support and advice.
Jocelyn L. Jacob
United Laboratories, Inc.
66 United St., Mandaluyong City
Tel 632-631-8501 (local 7086)
Back to the Top
Hi Dr. Jacob:
I assume that you want to perform this BA/BE study to be submitted to
FDA. In this case, I think that it may help you a lot if you take a look
on this link http://www.fda.gov/cder/guidance/4964dft.pdf
You will find all the information you may need in this link.
I hope that may help you.
Osama H. Mohamed
Ph.D. Candidate in Clinical Pharmacokinetics
College of Pharmacy, Oregon State University
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