MIC: in vitro… [PK / PD]

posted by Helmut Homepage – Vienna, Austria, 2020-07-30 13:41 (13 d 15:04 ago) – Posting: # 21805
Views: 722

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.

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,009 posts in 4,379 threads, 1,460 registered users;
online 12 (0 registered, 12 guests [including 6 identified bots]).
Forum time: Thursday 04:45 CEST (Europe/Vienna)

If you obey all the rules,
you will miss all the fun.    Katharine Hepburn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz