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In Vivo DMPK Service

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Creative Bioarray provides in vivo drug metabolism and pharmacokinetic (DMPK) services to support your drug development studies of in vivo absorption, distribution, metabolism, and excretion of drug candidates. Our in vivo DMPK services cover a comprehensive range of different animal studies in several species.

Creative Bioarray’s scientific team provides expertise in DMPK studies at all stages of R&D. We have extensive experience in designing, performing, and interpreting the results of DMPK studies in multiple species. Study design and selection of the appropriate models are often customized according to the objectives of each project. All studies could be performed under strict guidelines by highly trained and experienced scientists. Our mission is to meet our clients’ goal with superior quality and service.

Animal Species

  • Mouse
  • Rat
  • Hamster
  • Guinea Pig
  • Rabbit
  • Mini Pig
  • Beagle
  • Cynomolgus Monkey
In-Vivo-DMPK Service

In Vivo Services

In Vivo< Services

  • Pharmacokinetic and Toxicokinetic studies
  • PK and TK studies involve the application of animals that have been properly catheterized for drug administration and sample collection, specific surgical operations such as portal vein cannulation. bile duct intubation, Intraduodenally administration, etc. PK and TK study samples include blood, bile, urine, or other body fluids, as well as tissues and tumor specimens that have special bioanalytical necessity. Analysis of pharmacokinetic samples is typically performed using LC-MS/MS.

  • PK/PD Biomarker Analysis
  • In the new era of personalized medicine, well-defined biomarkers are critical factors and are used to predict the prognosis of individual patients and their response to the treatments. It is important to find the right biomarker for the right target in the right tissue for the right patient treated with the right treatment. To monitor the efficacy of drug candidates by PK/PD, we monitor specific biomarkers according to the requirements of the clients or the published data, to determine drug ADME properties.

  • Bioavailability and Bioequivalence
  • Bioavailability is referred to as the rate and extent to which a therapeutically active drug ingredient is absorbed into the systemic circulation and becomes available at the site of action, while bioequivalence means the similarity of drug products regarding their bioavailabilities. BA and BE studies are recommended by FDA for drug products in INDs, NDAs, and NDA supplements. Our team could assist with the study design, protocol development, pharmacokinetic and statistical data assessment, study result report, and raw data preservation.

  • Bioanalytical Package
  • Our bioanalytical package involves the determination of drug concentrations in biological specimens derived from PK/PD studies. The techniques used include LC-MS/MS and ELISA assays. All assays follow SOPs in which both QC/QA and GLP-compliance are implemented. Our dedicated staff with strong scientific and regulatory knowledge will ensure to provide high quality of services for our clients.

  • Mass Balance, Excretion and Expired Air Collection
  • Excretion mass balance studies can provide basic information on the elimination rates and pathways of candidate compounds. These related studies are one of the most important portions of regulatory submissions. We perform various mass balance studies in various species include mice, rats, and dogs.

  • Administration Routes and Biofluid Sampling
  • All routes of administration are feasible:

    Oral, Intravenous, Subcutaneous, Intramuscular, Trans dermal Intraperitoneal, Oropharyngeal, Intratracheal, Intranasal, Continuous infusion, Intravitreal, Ocular, Intrathecal, Portal vein (via access ports), Intraduodenal, Inhalation

  • Placental Transfer and Milk Secretion
  • Quantitative Tissue Distribution
  • Tissue distribution studies in animal models help determine the distribution and accumulation of the compounds or metabolites, especially in relation to potential sites of action. Our quantitative whole-body autoradiography (QWBA) capabilities enable rapid quantitation of tissue distribution in a variety of animal models.

  • Target Tissue Exposure
  • Creative Bioarray improves the evaluation of drug exposure in specific tissue. With a combination of quantitative mass spectrometry imaging technology and histology techniques, we localize and quantify the concentration of active compounds at cellular level. With ICP MS imaging, we detect elements, small molecules or peptides and quantify them.

  • Metabolite Profiling and Identification
  • Metabolite identification studies are often conducted using bioanalytical instruments such as LC-MS/MS and NMR. The purpose of this assay is to determine the metabolic pathway of the drug candidate. These studies are usually performed concurrently with mass balance excretion studies, and the source of the sample is typically plasma, urine or bile from mice, rats, dogs, monkeys or humans.

  • Blood-Brain-Barrier Assay
  • Blood-brain barrier is a highly selective semipermeable border that protects the brain microenvironment from toxins and pathogens in the circulation and maintains brain homeostasis. The principal sites of the barrier are endothelial cells of the brain capillaries whose barrier function results from tight intercellular junctions and efflux transporters expressed on the plasma membrane. This function is regulated by pericytes and astrocytes that form the neurovascular unit (NVU) together.

  • In Vivo Toxicity Study
  • Creative Bioarray specializes in rodent preclinical toxicology studies, directed towards preliminary screening and safety profiling of test articles. Combined with our in vitro cell-based toxicity studies, we could better identify and evaluate the toxicity of drug candidates in multiple organ systems.

With all of our in vivo services, we ensure continuous communications during the studies and will keep you informed of any progress or discoveries as well as questions and concerns. This ensures flexible study strategies and saves time and money by avoiding fruitless attempts. If you have any special needs or questions regarding our services, please feel free to contact us at info@creative-bioarray.com or 1-631-626-9181 to get support from our experienced experts. We look forward to working with you in the future.


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CONTACT US USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-626-9181
Fax: 1-631-614-7828
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Europe
Tel: 44-207-097-1828
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