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PK-PD and Toxicology Division

Overview | Missions and goals | Competencies | People | Area of research | Facilities | Current research | Projects
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Overview

The primary focus is to provide support to the ongoing drug discovery program of the institute in the areas of Pharmacokinetics, ADME and Toxicology and generate preclinical data.

Mission and goals

Development of validated protocols for HPLC/LC-MS-MS in terms of recovery, presicision, accuracy and reproducibility.
PK studies of new chemical entities.
Absorption (A), distribution (D), Metabolism (M), Elimination (E) and protein binding profile.
Safety pharmacology
Regulatory Toxicology

Competencies

Pre-formulation
Pharmacokinetics
Bioavailability/ Bioequivalence studies
ADME Studies
Phase I Studies
Preparation of Pre-clinical/ Phase I Dossiers
In vivo toxicology (as per OECD/Schedule Y guidelines)
Safety pharmacological studies (as per ICH guidelines)

Area of research

S/No Name Area of Research/Expertise E-mail
1.
Gurdarshan Singh Safety Pharmacology and Regulatory Toxicology singh_gd@iiim.res.in
2
P.N. Gupta Formulation & drug Delivery pngupta@iiim.res.in
3
Sheikh Tasduq Abdullah Toxicology, Chronic Skin and Liver Disorders stabdullah@iiim.res.in
4
Manoj Kumar Tikoo Pharmacokinetics Stability studies mktikoo@iiim.res.in
5
Surjeet Singh Safety Pharmacology and Regulatory Toxicology ssingh@iiim.res.in
6
Neelam Sharma CYP screening studies of in-house materials neelamsharma@iiim.res.in

Facilities
Pharmacokinetics and General Instrumentation

Main Instrumentation.

  • Shimadzu HPLC system (Class VP series)

  • Thermofinningan HPLC System (Spectra Series)

  • Thermo Multiscan Spectrum Elisa Reader

  • Perkin-Elmer LS 50B Well plate Spectroflurometer

  • Perkin-Elmer LS 55 Spectroflurometer

  • Shimadzu UV-1601 PC- Spectrophotometer

 

Safety Pharmacology lab facility

Main Instrumentation.

  • Multichannel Polygraph (Expermentia, Hungry)

  • Telemetry System (DSI, USA)

  • Radial Arm Maze (Coulbourn, USA)

  • Isolated Organ Bath (Bio-Pack System, USA)

  • Hot plate Analgesiometer (Ugo basile, Italy)

  • Clinical Biochemistry analyzer Chem-7 (Erba, Manheim, Germany)

  • Automated hematology analyzer (Sysmex, XT-1800i, Kobe, Japan)

Current
PK studies of various in-house lead molecules
Screening of in house molecules for CYP 450 activities
Microsomal stability studies of in-house lead molecules
Safety Pharmacological and regulatory toxicological studies of various in-house/sponsored molecules.
Projects

SNO Project Title Sponsored by
1.
Pre-clinical (PK-PD, Safety and toxicity profile) of new bioactive leads, and development of new combination drugs for cancer/tuberculosis
Council of Scientific and Industrial Research
2.
Pre-clinical Development of Botanical Leads and NCEs for IND Phase Council of Scientific and Industrial Research
3.
Nurturing a new Pan-CSIR drug pipe line: high Intensity preclinical, clinical studies on lead candidates (CSIR-DPL)
Council of Scientific and Industrial Research