TIPS FOR THE INDUSTRY TO LEVERAGE PHARMACOMETRIC REVIEW OF ANTIMICROBIAL AGENTS
Pharmacometrics is apparently important in drug R&D. The manufacturers with an intention to develop antimicrobial agents should take advantage of pharmacometrics to understand the PK-PD profile of the drug under study and build physiologically based PK (PBPK) and population PK models at early stage of drug development. The in vitro susceptibility testing data of clinical pathogenic isolates (bacteria or fungi) can be combined with PK data to inform trial design and the dosing regimens in clinical trials, to identify the optimal dosing regimen, and accelerate new drug launch. As drug R&D advances, real-time modeling is recommended by dynamic update of the predefined model to better understand which physiological, pathological, concomitant medication or other factors of patients are the significant covariates affecting the PK profile of the drug, and provide adequate data to support drug safety and efficacy. The following measures may be helpful for relevant entities to benefit from pharmacometrics.
The pharmaceutical companies should also pay attention to the following issues when applying the pharmacometric strategy and approaches to new drug development:
In conclusion, pharmacometrics is an intricate emerging discipline involving clinical pharmacology, physiology, pharmacology, toxicology, clinical medicine, microbiology, biology, and statistics. Pharmaceutical companies should strengthen pharmacometric team building via systematic professional education and training to meet the requirements of increasingly complicated new drug development.