Pre-Clinical and Toxicology

Pre-Clinical and Toxicology form the basis of drug development in VMRC.  The preclinical studies are the backbones of drug development. The stage comes before the clinical trials, during which various drug data points are collected, usually by carrying out preclinical studies and tests on animals. This step forms a part of multiple fields, including drug  metabolism, pharmacology, pharmacokinetics, toxicology, and  toxicokinetics. The main objective of the preclinical studies is to  check the drugs for safety to use in the first human testing of drugs.  Through the preclinical studies of drugs, we are able to establish the  no-observed-adverse-effect levels (NOAELs) on drugs and decide the  further course on phase-1 clinical trials.

Pharmacological studies gauge the biological effect, efficacious dose range and overall potency of the optimized lead. It is very important to perform all pharmacological studies in a relevant in vitro and in vivo test system, which has the closest resemblance to the human disease condition.

These studies give a further understanding of the mechanism of action of the lead and an in-depth understanding of the drug action by pharmacodynamic (PD) studies. Whereas pharmacokinetic (PK) studies give a detailed insight on drug distribution in different organs of study animals post drug treatment; toxicity studies support toxicity profiling and safety evaluation for the drug candidate which includes a battery of in vivo and in vitro mutagenicity studies; animal toxicity studies in two species.

Single dose acute studies could help determine the drug washout period and its correlation with signs of toxicity if any. Whereas repeated dose (TK) studies help to determine drug tolerability dose range from the area under the curve (AUC) of drug plasma level. These results eventually help to determine no-adverse-effect-level (NOAEL) and maximum tolerated dose (MTD) for the drug which ultimately helps in the calculation for a safer and potentially effective start-up dose regimen for human studies.

Currently, we are working in the following Area(s):

• In vivo Pharmacodynamic (PD) studies
• In vivo Pharmacokinetic (PK) studies
•  To evaluate dose-response and checkerboard combination analysis
• PK/PD correlation
• Toxicological studies