Bioequivalence and Bioavailability Forum

Hi Heritage,

❝ Thank you for valuable inputs. Do we evaluate T>MIC always in patients or it can be done in healthy vouln.?

T>MIC (actually t≥MIC) is called “Therapeutic Occupancy Time” (see this post). That’s a PK metric, not a PD endpoint. We performed such a study (antibiotic, MR vs. IR) a while ago. Be aware that

• MIC generally is an in vitro concentration. For most antibiotics in vivo MIC is based on a wacky calculation.
  
• For  most  (all?) antibiotics there is more than one MIC (different strains of bacteria show different susceptibilities).

@ElMaestro: Forget patients. You will never find ones with the same grade of infection. Parallel design difficult. Crossover impossible.

We performed a crossover in healthy subjects where we had three MICs.

• Confirmatory: One-sided test for the Occupancy Times (superiority).
  
• Exploratory: AUC (two-sided).
  
• Descriptive: C_max (no CI).