Anthem
Group Companies

Top quality service, timely delivery and proactive communication

Anthem
Group Companies

One stop solution for integrated drug discovery, process development and scale-up

Anthem
Group Companies

Anthem works closely with clients on IP related information

Anthem
Group Companies

The only CRO in the country with Microbiology division that provides antiinfectives screening services

Anthem
Group Companies

Proven Track Record for Hit-Identification, Hit to Lead and lead Optimization

Anthem
Group Companies

Highly qualified scientific team with diverse experience

Anthem
Group Companies

Cloning, expression and purification of recombinant proteins from both bacterial and mammalian host systems.

Drug Metabolism and Pharmacokinetics (DMPK)

The Drug Metabolism and Pharmacokinetics(DMPK) team members possess advanced degrees in relevant specializations from top universities in India and abroad and bring many man years of industrial experience. At Anthem the studies are performed using methods, instrumentation and technologies available with top tier pharmaceutical companies. The studies are carried out in a state of the art facility that includes experimentation labs and a vivarium.

In vitro DMPK

PHYSICOCHEMICAL PROPERTIES

  • Thermokinetic and thermodynamic solubility (MultiScreen HTS filter plates/ LC-MS/MS method)
  • Stability in buffer solutions, simulated gastric fluid and simulated intestinal fluid (Fasted and Fed), in plasma of different species like human, monkey, dog, rat and mouse.
  • Log D(7.4) : Shake flask method (n-octanol/cyclohexane: Phosphate buffer saline)
  • log P and pKa determination

DISTRIBUTION

  • Plasma Protein binding determination by Ultrafiltration method and Equilibrium dialysis
  • Species: human, monkey, dog, rat and mouse
  • In-vitro tissue binding
  • Blood cell partitioning
  • Microsomal binding

ABSORPTION / PERMEABILITY

  • PAMPA (Parallel Artificial Membrane Permeability Assay)
  • MDCK-wild type permeability
  • MDR1-MDCK permeability for P-gp interaction
  • Caco-2 permeability
  • a. Unidirectional permeability (Single or Multiple time points)
  • b. Bidirectional permeability (Single or Multiple time points): with and without Pgp inhibitor
  • Calcein AM assay for P-gp interaction and inhibition

METABOLISM

  • Metabolic stability in liver, intestinal microsomes, S9 fractions and hepatocytes
  • Metabolite identification (phase I and II) and characterization studies using LC- MS/MS
  • Species: rat, mouse, monkey, dog and human
  • Hepatocyte stability

In vivo PHARMACOKINETICS

SPECIES

  • Rat
  • Mouse
  • Hamsters
  • Guinea pigs
  • Rabbits

TYPES OF PK STUDIES

  • Single dose
  • Multiple dose
  • Cross over
  • Cassette dose

ROUTES

  • Oral
  • Intravenous
  • Subcutaneous
  • Intradermal
  • Intramuscular
  • Intraperitoneal
  • Per rectal, etc.

TISSUE DISTRIBUTION STUDIES (ORGANS)

  • Brain, liver, adipose, skin, muscle, spinal cord, etc.

PHARMACOKINETICS STUDY IN DISEASE MODELS

  • Cancer models eg. tumor bearing athytymic animals
  • Diabetes models eg. db / db mouse
  • Obesity models eg. Ob/ob mouse, DIO mouse
  • Inflamation models eg. IBD model, arthritis model
  • Tissue distribution in efficacy models and PK-PD correlation

EXCRETION

  • Biliary excretion in rats
  • Renal excretion in rats

PHARMACOKINETICS DATA ANALYSIS

  • WinNolin (Pharsight)
  • Parameters reported: Tmax, Cmax, AUClast, AUC∞, Cl, t1/2, Vss, MRT and F%
  • Plasma to tissue ratio

BIOANALYTICS

  • Method development and validation
  • Development of efficient/reproducible extraction procedures (protein precipitation, liquid- liquid extraction, solid-phase extraction)
  • Recovery and linearity studies
  • Development of analytical methods in Biological Matrix - plasma, serum, bone marrow, lymph node, urine, feces, bile, other tissues, samples from both in vivo and in vitro studies

INSTRUMENTATION

  • HPLC (PDA, Fluorescence), LC-MS-MS - Triple quad and QTrap
Integrated Discovery
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