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:

➤ Solubility; pKa; Log P

➤ GI stability under simulated gastric and simulated intestinal pH

➤ Plasma protein binding

➤ Whole Blood Partitioning / RBC uptake

➤ PAMPA/in-situ permeability

➤ Rat S-9/Microsomal Metabolic stability

➤ In-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:

➤ In vivo oral and intravenous pharmacokinetic studies in at least one rodent and one non-rodent species

➤ Tissue distribution

➤ Metabolite profiling

➤ Excretion studies (urine, feces and bile)

➤ CYP 450 Reaction Phenotyping

➤ In-vitro metabolic studies with Human Recombinant CYPs

➤ Toxicokinetics (integrated with 28 day repeat dose toxicity studies in rats and monkeys)

C). Herbal Products: The group is involved in:

➤ Defining the finger print / pattern profile of various components of the preparation using validated LC MS/MS assay procedure

➤ Principle Component Analysis of pure marker components of the herbal preparations

➤ Development of bio-analytical procedure for the quantification of marker components in biological matrices for evaluating DMPK characteristics

➤ The 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