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SAFETY & CLINICAL DEVELOPMENT PHARMACOKINETICS
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
 
 
 
 
 
Team members
  Dr J Lal
Dr Wahajuddin
Dr RS Bhatta
Dr JR Gayen
 
 
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