Jun, 1995 - Current
A preclinical toxicologist having 24 years of small molecule drug discovery and development experience with major area of toxicology with additional responsibility of biological testing of biologics. An experienced hand in setting up biology facility, screening techniques, ADMET, PK/PD. Independent taking of toxicology/safety program of new drug development from screening to IND filing in USFDA/EMA.
- Data review of pharmacological screening, in-vitro/vivo efficacy and DMPK to assess and identify tox candidate.
- Design and execute all types of investigative toxicological studies of NCEs.
- Conduct of chromosomal aberration, micronucelus, comet assay testing to establish genotoxic potential of NCEs
- Identify preclinical CRO, cost to studies, regulatory framework, protocol development, monitoring, report review of all types of tox studies for IND filing
- Preparation of Tox-Investigator's Brochure, preclinical summary, pre-IND document for USFDA/EMA.
- Practical hand in flowcytometer, microscopy, biochemistry analyzers, microplate readers, ELISA techniques, gel electrophoresis.
Dr. Babasaheb Ambedkar Marathwada University
Aug, 2009 - May, 2017
Drug combinations for humans are both beneficial as well as harmful but least documented. So I picked up the idea of doing such research to address likely effects of combined drugs through employing animal studies using lab mice and rats. I studied Linezolid antibiotic combining it with other prescribed medicines and investigated synergistic and adverse effects with the principles of system biology.
Dr Babasaheb Ambedkar Marathwada University
Jun, 1992 - Jun, 1994
Shri Chinnabasveshwar College of Pharmacy
Jul, 1988 - Aug, 1989
- Animal model for toxicological investigation of NCEs
- Toxicology study protocol and report writing
- Clinical pathology instruments
- Regulatory tox/CRO outsourcing
- IND filing