E-DRUG: analysis of bioequivalence for fixed dose combination?
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Hi E-druggers!
Is there anyone in the e-group that can add more information regarding the
statistical analysis for fixed dose combination of rifampicin and INH? We
calculated bioequivalence at 90% confidence interval of the relative mean
AUC of the test to reference product to lie within 80 to 125 percent. Did
you use population or individual bioequivalence? Is there a correction
factor if the comparator was a capsule against a test drug in the form
suspension. This happened because there is no suspension available for the
reference preparation.
Is there any other statistical maneuver for the presence of a sequence
effect? What is its effect on the final result?
I would appreciate it very much if you can communicate with me thru email at
pharmafaculty@hotmail.com or to Jody V. Dalmacion, MD,MSc, Department of
Pharmacology University of the Philippines College of medicine, 547 Pedro
Gil Ermita 1000 MetroManila, Philippines.
Thanks!
Jody V. Dalmacion, MD,MSc,
Department of Pharmacology
University of the Philippines College of medicine,
547 Pedro Gil Ermita
1000 MetroManila,
Philippines.
pharmafaculty@hotmail.com
jrvd2003@yahoo.com
[Rather technical question; normally better suited for INDICES, but given
the importance of the drug and FDC methodology, distributed to E-drug.
Technical BE fundi's - please respond directly to Jody at
pharmafaculty@hotmail.com. Thanks! WB]
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