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Hi all
If a innovator has 4 strenghts in a particular dosage form, is there
any way of finding out whether the formula is dose proportional ?
This mail is a continuaiton to my previous mail regardig BE studies
requirement in Canada.
I am interested in knowing the possibility of getting biowaiver for
the lower strenghts if we do Bioequivalence studies for the highest
strength of the innovator.
Regards
Vardhini
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Dear Vardhini,
The percentages for each ingredient is calculated as follows:
(Weight of the excipient/Total core weight)*100
Tolerance for the calculated percentages are specified:
Filler 5%
Disintegrant
Starch 3%
Other 1%
Binder 0.5%
Lubricant
CA or Mg Stearate 0.25%
Other 1%
Glidant
Talc 1%
Other 0.1%
These rules apply to conventional-release formulations.
More details are given in policy "Bioequivalence of proportional
formulations - Solid oral dosage forms" available on the Health Canada
- TPD web site.
radu
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