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As you all know, FDA has published a guidence for biowaiver in
Immediate release products. We are developing an extended release
product in the form of pellets in three different strengths. If all
strenghts are compositionally proportional and drug is water soluble,
highly permeable and displays linear kinetics, if we do
bioequivalence testing on highest strength, can we get biowaiver for
all the lower strengths. The orange book lists all three strenghts as
RLD. Could somebody throw light on this?
Regards,
Sunil V
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