Pre-Clinical and Toxicology

Backing drug discovery and development process.


Preclinical studies are the backbone of drug discovery and development. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile.

These studies fall into the general areas of pharmacology, drug metabolism, pharmacokinetic, toxicology and toxicokinetic. The detailed animal testings are required before human studies are being conducted to assess the need for the proposed use and urgency of its application.
Our preclinical lab is approved by National GLP Compliance Monitoring Authority (NGCMA), Department of Science & Technology, Government of India for testing of Acute Toxicity and Sub-acute Toxicity.

Areas Interest

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
  • PK/PD correlation
  • Toxicological studies

Pre-Clinical and Toxicology

Team Profile

Dr. Dilip Kumar Roy

Head Scientist | Preclinical Research

Dr. Dilip Roy

Contact at:

Recently Published Work

Protective role of ceftriaxone plus sulbactam with VRP1034 on oxidative stress, hematological and enzymatic parameters in cadmium toxicity induced rat model.
Interdisciplinary toxicology, 5(4), pp.192-200.

Dwivedi, V.K., Bhatnagar, A. and Chaudhary, M., 2012.

Comparative study of CSE 1034 and ceftriaxone in pneumonia induced rats.
Clin. Exp. Pharmacol., 2, pp.1-7.

Dwivedi, V.K., 2012.

Therapeutic and safety study of intravenous disodium EDTA on QT prolongation and serum electrolytes in a rabbit.
The Journal of Toxicology and Health. 103, pp. 293-299.

Chaudhary, M. and Dwivedi, V.K.,2016

Acute intravenous toxicity study of disodium EDTA in Swiss albino mice.
World J. Pharm. Pharm. Sci, 5(10), pp.866-873.

Chaudhary, M., Kumar, P., Kumar, S. and Kumar, V., 2016.

Subacute intravenous toxicity study of disodium EDTA in Swiss albino mice.
World J. Pharm. Pharm. Sci, 5(10), pp.1100-1115.

Chaudhary, M., Kumar, P., Kumar, S., Sachdeva, A. and Kumar, V., 2016.


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