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ADME DMPK Studies

Aurigene Pharmaceutical Services offers a wide range of services in the area of in-vitro and/or in-vivo ADME-DMPK studies. With decades of experience, our dedicated team of DMPK-ADME scientists have provided innovative solutions to major pharma and biotech companies globally, in their early and late-stage discovery programs. Our DMPK team is seasoned in integrated drug discovery services and has been associated with +60 drug discovery programs.

Our validated DMPK assays can be enabled with different study designs as per the project needs or can be customized to suit the customer requirements. We provide quality and reproducible data with quick turnaround times to help meet tight timelines required in drug discovery. Our GLP accredited bioanalytical facility has supported +200 GLP studies.

 

Why Aurigene Pharmaceutical Service?

Turn Around Time

In-Vitro Assays: 5 Working days In-Vivo PK Studies: 7 Working Days

Expertise

Stand-alone DMPK services and Integrated Medicinal Chemistry - DMPK services for small molecules and therapeutic peptides.

Tailored Studies

Customized study designs to suit customer requirements.

Bioanalysis

GLP accredited labs for bioanalysis for PK, PD and Toxicology studies. Delivered +200 GLP studies. Non-GLP bioanalysis for HTS ADME, PK, Pharmacology and Toxicology studies. Bioanalysis of small molecules, therapeutic peptides and biomarkers.

 

Our Services include:

 

ADME-DMPK Studies

  • Physicochemical Parameters
  • Metabolism Studies
  • Permeability
  • Distribution
  • Drug-drug Interactions
  • Pharmacokinetics
  • Bioanalysis
 

Physicochemical Parameters

  • Kinetic and Thermodynamic Solubility at different pH, SIF and SGF
  • Chemical Stability at various pH, SIF and SGF
  • Log D
 

Metabolism Studies

  • Microsomal Clearance and S9 Phase I and II
  • Hepatocyte Clearance
  • Plasma Stability
  • CYP Phenotyping
  • Metabolite Identification
 

Permeability

  • Caco-2 Bi-directional Permeability and Efflux Ratio
  • MDCK Permeability
  • PAMPA
 

Distribution

  • Plasma Protein, Brain and Microsome Binding
  • Blood to Plasma Partition
  • Brain to Plasma Partition
 

Drug-drug Interactions

  • CYP Inhibition, CYP TDI and Kobs
  • CYP Induction
  • P-gp and BCRP Inhibition and Substrate Identification
 

Pharmacokinetics

  • PK in Rodents (rats/ mice): Single/ multiple-dose, discrete/ cassette, microsampling, cross-over/ non-cross-over design
  • Single/multiple dose PK in Beagle dogs
  • Tissue distribution, brain penetration, excretion, food effect, gender effect and dose escalation studies in rodents using the cold compound
  • Surgical models: Cannulations of single or double Jugular vein, tail vein, duodenum, bile duct, and femoral vein in rat
 

Bioanalysis

  • In-Vitro ADME - Generic Gradient Method
  • In-Vivo PK, PK/PD and TK
  • GLP compliant, State-of-the-art Bio-analytical lab to support
  • Bio-analytical Method Validation
  • Pharmacokinetics and Tissue Distribution Studies
  • Toxicokinetic Studies