Dr. Dilip Kumar Roy

Efficacy and safety studies are a very important tool in drug discovery and development. It may be for the new molecule or novel formulation of an existing molecule. Only the in-vitro test is not sufficient to evaluate the efficacy of any compound. Testing in the animal model gives a true picture of efficacy in a more complex biological system as there are remarkable anatomical and physiological similarities between humans and animals. On the other hand, safety is more important before initiation of human studies. Toxicity studies identify possible hazards of a test substance which may likely be produced after single and multiple uses. The information collected from these studies is vital so that safe human testing can begin. Based on preclinical trials, no-observed-adverse-effect levels (NOAELs) on drugs are established, which are used to determine initial phase 1 clinical trial dosage levels on a mass drug per mass patient basis.

PK/PD studies in animals vital for determining dose and dosing interval of antibiotic. Dosing of antibiotic is determined by correlating exposure and response relationship (PK/PD) in human against drug-susceptible and resistant bacteria and this PK/PD index is determined by animal studies. We have completed several experiments on animal models for infectious disease (Thigh infection, lung infection and UT infection) and few are in pipeline ( Gonorrhoea, septicemia).