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The following message was posted to: PharmPK
hi
I am developing three strength of the immediate
release dosage forms. The bio strength is highest
strength. Because of the large difference of the
strength and the weight of the tablets (proportional),
I could not match the dissolution profile of the
lowest and higher strength. The drug exhibit the
linear pharmacokinetics. Can I get the biowaivers for
the lower strength based on the linear pharmacokinetic
reference.
ketan
R&D
[What is the absolute bioavailability of highest strength? In what
way did the dissolution profiles differ? High/low solubility,
permeability? - db]
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