title: Tools to define the relevance of PK/PD parameters to the efficacy, toxicity and emergence of resistance of antimicrobials.
abstract: In vitro and in vivo pharmacokinetic (PK) and pharmacodynanmic (PD) modeling have been effectively utilized in early drug development across a range of therapeutic disciplines to define the relationship between efficacy-related active drug concentrations in the serum and plasma. In addition to phase I and phase II PK data, human clinical trials enhance the PK and PD information gained from preclinical research. More recently, PK/PD models have been utilized to evaluate the potential for the targets of specific drug classes to develop drug resistance. In addition, PK/PD modeling tools have been used to address the issues associated with relationship of drug exposure to toxicity in preclinical and clinical settings. As more clinical data is collected on new classes of antibiotics, or specific compounds, there will be a need to perform PK/PD assessments to evaluate the in vitro and preclinical in vivo data because the compilation of both sets of information relates to human clinical outcome data.
authors.affiliation: Merck Research Laboratories, Infectious Disease Research, RY80Y-255, 126 E Lincoln Avenue, Rahway, NJ 07090, USA. emily_hickey@merck.com
authors.forename: Emily
authors.initials: E
authors.lastname: Hickey
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology; D019540:Area Under Curve; D001424:Bacterial Infections / Q000188:drug therapy* / Q000378:metabolism / Q000382:microbiology; D002986:Clinical Trials as Topic; D024881:Drug Resistance, Bacterial; D006801:Humans; D008826:Microbial Sensitivity Tests; D008954:Models, Biological; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents