MIC: in vitro… [PK / PD]

posted by Helmut Homepage – Vienna, Austria, 2020-07-30 13:41 (788 d 10:33 ago) – Posting: # 21805
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Hi Dshah,

of course, all what you wrote is correct. I performed studies for an originator (new formulation), where t≥MIC* was the only confirmatory PK metric (see also this post). Studies accepted.

[image]However, we must not forget one important point: The MIC is based on in vitro data. Generally we have more than one MIC (dependent on the bacteria / strain). Everybody (myself included) compared the in vivo concentrations of the PK study with the in vitro MIC. That’s not the same thing… Is there a 1:1 relationship? I strongly doubt it.
Can/should we really do that? Well, cough… :lookaround:

BTW, we have a similar mix-up of PK with PD in the so-called “Therapeutic Occupancy Time” based on the misconception that Cmax is directly (‼) related to safety (toxicity) and Cmin to a potential lack of efficacy. See also this post.



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