My laboratory work on the understanding of pharmacokinetics of NCE’s in relationship to its underlying biologic mechanisms. Pharmacokinetics described as what the body does to a drug, refers to the movement of drug into, though, and out of the body—the time course of its absorption, distribution, metabolism, and excretion. By evaluating the pharmacokinetics properties of NCE’s we tend to determines the onset, duration, and intensity of a therapeutic agent. We carry out regulatory and clinical pharmacokinetic studies.
Our lab is also involved in factors affecting biological drug concentration time profile and strategies to improve efficacy / bioavailability of NCE’s
➤ Bioanalytical and Analytical Method Development :
Development of bioanalytical and analytical method using HPLC and LC-MS/MS platform for estimation of NCE’s, drugs, metabolites, peptides etc in different biological matrices and formulations as by regulatory guidelines such as US-FDA, ICH etc
➤ Clinical and Preclinical Pharmacokinetic Studies:
Regulatory pharmacokinetic and toxicokinetic studies of NCE’s. Estimation pharmacokinetic parameters, bioavailability, dose-proportionality, gender variation, inter-species comparison, tissue distribution characteristics, excretion studies etc
➤In-vitro Metabolism, Metabolite Identification and Drug-Drug Interaction:
In-vitro-In-vivo Extrapolation (IVIVE) for prediction of human clearance. Elucidation of metabolism pathway of NCE’s, metabolite identification. Drug-drug, herb-drug and food-drug interaction studies
➤Biopharmaceutics:
Permeability/Absorption characterization Studies across Caco-2, MDCK cell line, inverted gut sac method and in situ rat model. Protein binding and simulated gastro-intestinal stability for NCE’s/drugs. In-vitro-In-vivo correlation (IVIVC).
➤ Pharmacokinetic and pharmacodynamics modelling:
Mathematical modelling of PK and PK-PD data are carried out. These mathematical model are used for simulation of drug concentration profile prior to in-vivo studies and help in optimization of dose and dosage regimen. We also do the extrapolation of plasma concentration of preclinical species to estimation of clinical pharmacokinetic profile prior to clinical studies.
➤ Drug Delivery:
Designing formulation for NCE’s, ocular drug delivery