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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 studies - 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

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FAQ

ADME data helps scientists assess and optimize the absorption, distribution, metabolism, and excretion of the drug/NCE early in the drug discovery process. This helps to minimize late-stage failures in in-vivo safety and efficacy studies and clinical trials.

ADME testing involves various in-vitro and in-vivo assays used to assess the properties that determine the Absorption, Distribution, Metabolism, and Excretion (ADME) of NCEs/ drug molecules.

The ADME process involves the characterization of a drug by using different assays to determine its absorption, distribution, metabolism, and excretion properties. This data is critical to prioritize and advance drug/ NCEs for future development.

DMPK is the study of the drug-like properties of new chemical entities(NCE)/drugs to understand its metabolism and pharmacokinetic profile.

PK studies are an integral part of drug development. It helps to understand a new chemical entity (NCEs)/drug’s pharmacokinetic behaviour in the body and involves the study of distribution, metabolism, clearance and bioavailability.

Pharmacokinetics (PK) is the response of the body to the drug. Whereas Pharmacodynamics (PD) is the action of the drug on our body.

Pharmacodynamics (PD) of a drug refers to the biochemical and physiological effects caused by the drug/NCE in the body.

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