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Dear colleagues,
We will be doing BA/BE of Fixed Dose Combination Products e.g.
Telmisartan
+ Hydrochlorothiazide, Carvedilol + Hydrochlorothiazide, etc.
Can anyone tell me if both actives need to be measured, or can we just
measure Telmisartan or Carvedilol blood levels considering that
Hydrochlorothiazide is a diuretic ?
Thanks.
Joy
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Dear Mr.Joy,
You should measure both the actives i.e., both Telmisartan,
Hydrochlorothiazide and Carvedilol, Hydrochlorothiazide, in a fixed dose
combination product and should subject both the actives to 90% CI
Whether
you administer reference product in a fixed dose combination or
individually.
V.Radhakrishna
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)