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DMPK

DMPK

Our expertise in wide range of DMPK studies provide our clients with customized, innovative and integrated drug discovery solutions with quick turnaround times.

Our DMPK team is having expertise in both integrated drug discovery and standalone DMPK services with experience over 16 years. Our capabilities helped us to deliver more than 65 IDD projects. We design customized protocols and perform assays based on client or project requirements. The DMPK facility spanning an area of 10,000 sq.ft. in Bangalore and Hyderabad locations consists of state-of-the-art in vitro ADME and tissue culture labs, AAALAC accredited animal facility for in vivo PK studies in rats, mice & dogs and GLP & Non-GLP bioanalytical labs with high-end LC-MS/MS instruments.

In vitro ADME capable of high-throughput screening with best in industry turnaround times. In vivo PK studies with various established surgical models. Experience in DMPK studies and bioanalysis of small molecules, PROTACs, therapeutic peptides and biomarkers. Automated compound management and data handling systems.

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DMPK Studies

  • Physicochemical parameters
  • Metabolism studies
  • Permeability
  • Distribution
  • Drug-drug interactions
  • Pharmacokinetics
  • Bioanalysis

Physicochemical Parameters

  • Kinetic, high-throughput and thermodynamic solubility at different pH, SIF and SGF
  • Chemical stability at various pH, SIF and SGF
  • Log D, Chrom Log D

Metabolism Studies

  • Clearance in microsomes, hepatocytes, S9
  • Phase I and II metabolism, glucuronidation, glutathione, sulfation
  • Stability in plasma, blood
  • CYP phenotyping
  • Metabolite identification

Permeability

  • Caco-2 bi-directional permeability and efflux ratio
  • MDCK (native), MDCK-MDR1, MDCK-BCRP
  • PAMPA

Distribution

  • Plasma protein and in vitro tissue 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, micro sampling, 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 rats

Bioanalysis

  • In vitro DMPK assays - 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

 

Why Aurigene Pharmaceutical Services?

Turnaround time: In vitro Assays: 5 working days. In vivo PK Studies: 7 working days

Quality & accuracy

Customized protocols

Compound management and data automation

Broad panel of in vitro ADME & in vivo PK study designs

Bioanalysis of small molecules, therapeutic peptides, biomarkers and complex molecules. Delivered 200+ GLP studies

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Frequently asked questions

Why is ADME important?

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.

What is ADME testing?

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.

What is the ADME process?

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.

What is DMPK in drug discovery?

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

What is the purpose of a PK study?

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.

What is the difference between PK and PD?

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

What are the recommended storage conditions for Oligonucleotides?

For a period of 6 weeks, Oligos can be stored in T10E1 buffer at 37°C and for the long term, Oligonucleotides can be dried down and stored with or without TE buffer at -20°C.

What is pharmacodynamics of a drug?

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

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