In Vivo Models

Animal infection models have been utilized to evaluate anti-infective agents for the treatment of experimentally-induced infection since the dawn of modern anti-infective chemotherapy in the 1930s. At present, pharmacokinetic-pharmacodynamic (PK-PD) animal infection models serve as the basis for the pre-clinical assessment of anti-infective agents, dose regimen support, selection of in vitro susceptibility breakpoints, and for the evaluation of the meaning of in vitro drug resistance. ICPD scientists have been involved in the design and analysis of data from a variety of animal infection models for a wide range of pathogens. Our analyses have been effectively used by pharmaceutical company sponsors, governmental agencies, and others to identify clinically effective dose regimens for further clinical study or clinical use.

ICPD designed- and analyzed-animal infection models stand apart in several ways. For instance, ICPD typically advocates that animal PK profiles be humanized, a process that refers to the development of novel animal dosage regimens that provide animal plasma drug
concentration-time profiles similar to that observed in man. Moreover, ICPD scientists have been at the forefront of improving study design in other ways, including optimizing PD sampling schedules and developing and applying mechanism- and disease-based PD models instead of using traditional empiric and less informative methods of data analysis. These advanced designs, analyses, and techniques allow for optimal
animal-to-human translational inferences to be made, which decreases the probability of suboptimal design of clinical studies and thus, risk to a drug development program.