Clinical exposure-response (CER) relationship

The relationship between plasma/serum drug levels (exposure) and clinical efficacy (response) in patients.

Establishing exposure-response relationships is important for determining the optimal dose and dosing intervals of a drug treatment, to achieve the best balance between drug efficacy and the risk of adverse events.

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

Pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (EMA, 2015)

Guidance for industry exposure-response relationships — Study design, data analysis, and regulatory applications (FDA, 2003)