In Vitro
ADME Studies

In Vitro ADME Studies

We provide quality data in all the stages of drug discovery cycle, through our comprehensive and customized platforms of in vitro ADME services. These are needed to predict pharmacokinetics (PK) and pharmacodynamics (PD) in vivo through IVIVC (in vitro-in vivo correlation). Few reasons behind the robustness of our in vitro ADME data across years:

  • Utilization of lot specific bio-reagents (microsomes, hepatocytes etc.) and reagents from specific vendors
  • Employing control, FDA recommended compounds as quality control(s) in all in vitro ADME assays and release of the data when the control values match our historical data as well as literature data

Offering a comprehensive list of assays, from early discovery to definite regulatory designs, supported by our bioanalytical services unit for method development and validation, our in vitro ADME services are available for small and large molecule drugs, and can be tailored to fit the specific requirements of your program.

ADME services

Physicochemical Studies

  • Solubility (pION, Kinetic, Thermodynamic, FaSSIF, FeSSIF and FaSSGF) 
  • Stability (buffer, pH, plasma etc.)
  • Lipophilicity (LogP, LogD and pKa_ by Spectramax)

Permeability /Transporters

  • PAMPA-GIT, BBB, skin
  • Caco-2/MDCKII, MDCKII-MDR1 permeability
  • ABC/SLC transporters
  • Transdermal diffusion (porcine and human skin)
  • Buccal permeability

Distribution

  • Plasma Protein Binding across species (Rapid Equilibrium Dialysis_ RED, High throughput Dialysis_HTD and Ultra-centrifugal methods)
  • Matrixes Protein Binding
  • Blood Cell Partitioning

Metabolism

  • Metabolic stability: hepatic and extrahepatic (microsomes, S9, hepatocytes): Phase 1 and 2: CYP-mediated and non-CYP mediated
  • Reactive metabolites (Glutathione and Potassium cyanide adduct)
  • CYP Inhibition (8 isoforms: cocktail and individual approaches) 
  • CYP induction (PXR, CAR and AhR) in induction qualified hepatocytes
  • Time Dependent Inhibition/Mechanism Dependent Inhibition /Drug –drug Interactions

The requirement of In vitro studies is typically 5 mg compound (to conduct all assays) with a turnaround time of 5-7 working days.

Brochure

ADME – DMPK

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Whitepaper

A Novel Cell-based Screening Assay for Cholesterol Biosynthetic Pathway Inhibition Using the RapidFire HTMS Platform

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Whitepaper

Pharmacokinetic Strategies in CNS Drug Discovery

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