Generating robust and informative nonclinical in vitro and in vivo bacterial infection model efficacy data to support translation to humans.

Generating robust and informative nonclinical in vitro and in vivo bacterial infection model efficacy data to support translation to humans. Antimicrob Agents Chemother. 2019 Mar 04;: Authors: Bulitta JB, Hope W, Eakin AE, Guina T, Tam VH, Louie A, Drusano GL, Hoover JL Abstract In June 2017, The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, organized a workshop entitled "Pharmacokinetics-Pharmacodynamics (PK/PD) for Development of Therapeutics against Bacterial Pathogens". The aims were to discuss details of various PK/PD models and identify sound practices for deriving and utilizing PK/PD relationships to design optimal dosage regimens for patients. Workshop participants encompassed individuals from academia, industry and government, including the United States Food and Drug Administration. This and the accompanying review on clinical PK/PD summarize the workshop discussions and recommendations. Nonclinical PK/PD models play a critical role in designing human dosage regimens and are essential tools for drug development. These include in vitro and in vivo efficacy models that provide valuable and complementary information for dose selection and translation from the laboratory to human. It is crucial that studies be designed, conducted and interpreted appropriately. For antibacterial PK/PD, extensive published data and expertise are available. These have been leveraged to develop re...
Source: Antimicrobial Agents and Chemotherapy - Category: Microbiology Authors: Tags: Antimicrob Agents Chemother Source Type: research