Introduction

The Pharmacokinetics group is involved in:
A)  Synthetic NCEs: Development of validated bio-analytical assay procedures for quantification of NCEs in biological matrices, as per ICH guidelines, using HPLC and LC MS/MS
Evaluating important in-vitro DMPK parameters at the discovery phase so as to help in candidate selection, which include:
image01Solubility; pKa; Log P
image01GI stability under simulated gastric and simulated intestinal pH
image01Plasma protein binding
image01Whole Blood Partitioning / RBC uptake
image01PAMPA/in-situ permeability
image01Rat S-9/Microsomal Metabolic stability
image01In-vitro metabolite profiling



B) Generating regulatory DMPK data to define drug metabolism and disposition, PK-PD correlation, PK-TK correlation, dose and dosage regimen at the preclinical development phase so as contribute in submission of IND applications to DCGI for the grant of permission to conduct human clinical trials; These studies include:

image01In vivo oral and intravenous pharmacokinetic studies in at least one rodent and one non-rodent species
image01Tissue distribution
image01Metabolite profiling
image01Excretion studies (urine, feces and bile)
image01CYP 450 Reaction Phenotyping
image01In-vitro metabolic studies with Human Recombinant CYPs
image01Toxicokinetics (integrated with 28 day repeat dose toxicity studies in rats and monkeys)

C) Herbal Products: The group is involved in:

image01Defining the finger print / pattern profile of various components of the preparation using validated LC MS/MS assay procedure
image01Principle Component Analysis of pure marker components of the herbal preparations
image01Development of bio-analytical procedure for the quantification of marker components in biological matrices for evaluating DMPK characteristics
image01The group also undertakes work to define preclinical DMPK characteristics of multi-component herbal preparations based on the biologically active markers, which helps in taking them up to clinical trial level





Team Members

image01 Dr J Lal
image01 Dr RS Bhatta
image01Dr Wahajuddin
image01Dr JR Gayen