Drug Metabolism and Pharmacokinetics ::
To evaluate Absorption, Distribution, Metabolism, Excretion (ADME) properties of NCEs using various in vitro, ex vivo and in vivo models. The department is well equipped with automated instruments to carry out ADME studies and bioanalysis.
- Evaluation of gastrointestinal permeability, metabolic stability, plasma protein binding using in vitro and ex vivo models; artificial gut membrane/ single pass intestinal perfusion, liver microsome/S-9 fractions and ultra-filtration membrane respectively.
- Evaluation of interspecies difference in metabolism and determination of metabolic pattern of compounds (identification of Phase I and II metabolites).
- Evaluation of in vitro Cytochrome P450 drug-drug interaction and reaction phenotyping.
- Pharmacokinetics and Tissue distribution studies of NCEs after oral, intravenous, intraperitoneal and intramuscular route using rodent animals (rats, mice, guinea pigs, rabbits).
- Determination of major route of excretion (urine, feces, biliary).
- Interpretation of pharmacokinetic parameters (plasma exposure, half life, elimination rate, volume of distribution, steady state etc.) to establish possible PKPD correlation, assess safety margin etc. in animal and human studies.
- Support of ADME screening, preclinical pharmacokinetic (PK) and toxicokinetic (TK) studies
- Performance of both GLP-compliant and non-GLP method development and validation for analytical and sample preparation
- Performance of GLP bioanalysis of plasma samples from human clinical trials
- Handling projects ranging in size from a few to several thousand samples
- Bioanalytical method development and transfer
Training programs for Postgraduate students from Birla Institute of Technology and Science, Gujarat University, Manipal University etc. are conducted at the center. Research Projects are also carried out successfully.