PK/PD index

Quantitative model to establish the relationship between pharmacokinetic and pharmacodynamic parameters.

PK/PD indices may be identified from in-vitro, ex-vivo and in-vivo PD models and support the development of new antimicrobials and dosing optimization of old antimicrobial agents.

Depending on the antimicrobial class, three relevant indices are traditionally described:

• the ratio of the (unbound) 24-h area under the curve to MIC (fAUC24/MIC);
• the ratio of the free maximal concentration to MIC (fCmax/MIC); and
• the time above the MIC expressed as a percentage of the dosing interval (f%T>MIC).

The magnitude for a PK/PD index describes at which level a required response is achieved.

It helps to design dosing strategies to increase the probability of success of the antibiotic therapy, as well as minimize the side effects and the emergence of resistance.

The role of PK/PD analysis in the development and evaluation of antimicrobials (Pharmaceutics, 2021)

Preclinical pharmacokinetic/pharmacodynamic studies and clinical trials in the drug development process of EMA-approved antibacterial agents (Clinical Pharmacokinetics, 2020)

Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products (EMA, 2016)