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Covance – Drug Metabolism and Pharmacokinetics (DMPK) Solutions

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About Covance – Drug Metabolism and Pharmacokinetics (DMPK) Solutions

Divison of: Covance

Characterize Your Drug Candidate’s ADME Properties

Get a complete range of ADME services to streamline your candidate optimization, early and late development program. With 1,000s of studies conducted annually, you have access to the broadest, deepest and most experienced group of dedicated DMPK scientists in the CRO industry to help you to meet the latest regulatory expectations and avoid delays in your development program.

  • In Vitro ADME Studies
  • Preclinical PK/PD Studies (including Fast PK)
  • Metabolite Profiling
  • In vivo ADME Studies
  • PK/PD Modeling

Our Services (19)


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IND-Enabling Studies

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In vivo Percutaneous Absorption Studies

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Toxicology

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In vitro Percutaneous Absorption Studies

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In vitro ADME/DMPK Studies

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  • Enzyme inhibition (e.g. CYP & UGT); determination of IC50, IC50 shift, and Ki, KI, Kinact, etc.
  • In vitro CYP induction assessment using human hepatocytes; enzyme activity and mRNA analysis; determine EC50, Emax
  • Ex vivo enzyme induction (rodent, canine, nonhuman primate)
  • Identification of enzymes involved in metabolism (e.g. CYP, UGT, AO MAO etc.) using selective inhibitors and recombinant enzymes
  • In vitro Met ID and metabolic stability; species comparison; microsomes, hepatocytes, or other matrices
  • In vitro and ex vivo plasma protein binding species comparison (equilibrium dialysis, ultrafiltration etc.)
  • In vitro and ex vivo blood cell partitioning
  • In vitro Caco-2 permeability, P-gp and BCRP assessment
  • In vitro drug-transporter interactions involving key human drug transporters as required by regulatory agencies
  • In vitro dermal absorption in human and animal skin
  • In vitro covalent binding and reactive intermediate assessment
  • Custom in vitro investigational experiments as requested

in vitro Toxicology

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In vivo PK/PD Studies

Price on request
  • Global capacity with harmonized processes to meet individual client needs

  • Large and small molecule experience

  • Definitive and HT screening pharmacokinetics and formulation testing in animal models (rodent, canine, nonhuman primate, rabbit, minipig, other species)

  • Fast PK – from powder (formulation) to PK report in 5 days or less

  • Quick start NHP PK using naïve or biologic-naïve/non-naïve animals (if available)

  • Colonies of non-naïve canines and NHP; client owned colonies also available

  • Calculation of PK parameters using Phoenix® WinNonlin®

  • Specialty surgical models available including, but not limited to:

    • Cannulation: jugular vein, portal vein, intestinal (multiple), pulmonary artery/vein
    • Bile duct cannulation
      • NHP: acute
      • Canine: acute and recirculating
      • Minipig: acute and recirculating
    • Serial survival (laparoscopic) liver biopsy: canine and NHP
    • Survival biopsy procedures: muscle, colon, skin
    • Serial survival CSF collection
    • Cisterna magna and lumbar catheterization for serial CSF collection in NHP
    • R&D services available for new model development
  • Excretion and mass balance

  • Placental and lacteal transfer (mouse, rat)

  • Distribution by quantitative whole-body autoradiography (QWBA) and excision (mouse, rat, rabbit, nonhuman primate)

  • Expired CO2 collections (mouse, rat, hamster)

  • Microautoradiography

  • Biliary excretion and enterohepatic cycling (mouse, rat, canine, minipig, rabbit, nonhuman primate)

  • Portal vein cannulation (rat, canine, nonhuman primate)

  • Dosimetry calculations for human radiolabeled studies meeting US and European regulations

  • Human metabolism and excretion (Phase I clinical study)

  • Studies with different isotopes (14C, 3H, 125I, 131I, 32P, 33P, 35S, others as requested)

  • Studies in many animal species [mouse, rat, hamster, guinea pig, ferret, rabbit, canine, nonhuman primate (cynomolgus and rhesus macaque), mini-pig]

  • Specialized routes of administration such as: intravenous infusion, dermal, ocular, intravitreal, sub-Tenon, inhalation, intravesicular

  • Ocular pharmacology, ADME and PK

  • Transgenic and tumor animal models available

  • ADME in livestock and avian species to support agrochemical and animal health product development

PK/PD Toxicology

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Metabolite Identification

Price on request
  • High resolution accurate mass determination – via Q Exactive™, OrbiTrap®, Ion mobility & QToF instrumentation
  • Radiolabeled and non-radiolabeled
  • NMR (access through partner)
  • Simultaneous collection of radio and MS profiles
  • Sciex 5500 QTRAP platform available if required
  • Dedicated team of Met ID scientists (PhD level) with extensive experience


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PBPK Modeling

In silico absorption, distribution, metabolism, and excretion
Price on request
  • Large and small molecule compartmental/noncompartmental analysis (Phoenix® WinNonlin®)
  • Bioavailability/bioequivalence/biosimilars
  • PK/PD modeling and simulation
  • Population pharmacokinetics (NONMEM®)
  • Prediction of human PK using allometric scaling and in vitro scale up
  • Physiologically Based PK Modelling (DDI prediction, mechanistic PK/PD, formulation optimization, FIH dose prediction)
  • Phase I and II clinical PK
  • Consulting services

PK/PD

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Toxicokinetic (TK) Modeling

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PK/PD Data Analysis

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Pharmacology & Toxicology

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Omics

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Metabolomics

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Biology

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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In vitro Disease Models

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In vitro Disease Models Services


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Cells and Tissues

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Cells and Tissues Services


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Animal Models and Studies

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Animal Models and Studies Services


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Drug Discovery & Development

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Drug Discovery & Development Services


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Pharmacology

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Pharmacology Services


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