MIC: in vitro… [PK / PD]

posted by Helmut Homepage – Vienna, Austria, 2020-07-30 13:41 (284 d 19:56 ago) – Posting: # 21805
Views: 1,895

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
21,446 posts in 4,483 threads, 1,511 registered users;
online 13 (0 registered, 13 guests [including 11 identified bots]).
Forum time: Tuesday 09:38 CEST (Europe/Vienna)

The fact that some geniuses were laughed at
does not imply that all who are laughed at are geniuses.    Carl Sagan

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