ka vs. Cmax [Dissolution / BCS / IVIVC]

posted by mittyri – Russia, 2017-06-10 16:59 (2509 d 03:40 ago) – Posting: # 17483
Views: 13,978

Hi Helmut & nobody,

Just got a chance to listen Laszlo Tothfalusi regarding this one

I'm not Nick H. and not Mats K. ever, but for me the problem is oversimplified there (Linked PKPD model with Concentration dependent hazard).

Since Ka is a key parameter (OK,ok, bioavailability) for bioequivalence, we need to get more suitable model for absorption of each drug (taking into account different rates for different parts of intestine, first-pass metabolism, distributed delay of absorption and so on)
PBPK guys are trying hard but it is still just endless investigations...

Even if all things are done, we got some tricky distribution of Ka among the population depending on formulation and many other things. Then we need to compare the distributions in some given populations...
Oh, sorry, looks like I was overdosed by popPK people :-D
—
Kind regards,
Mittyri

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