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In Vivo Pharmacokinetic Assays

In Vivo Pharmacokinetic Assays

Medicilon has significant experience in pharmacokinetics research. We offer a broad spectrum of high quality services involving all small molecule and large molecule (protein and antibody) candidate types, with service contents including in vitro ADME, in vivo pharmacokinetic and bioanalysis assessments. The test subjects involved include non-human primates, dogs, rats/mice, rabbits and guinea pigs.
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Medicilon icon-diamond.pngServices
  • Multi-cycle cross BE/prescription screeningTissue distribution/blood-brain barrier permeability Kp,uu (in vivo fraction)Excretion studies/in vivo metabolite identificationIn vivo drug interactionsPK/PD in tumor-bearing rats125I/14C/3H labeled isotope drug PK/tissue distribution/material balanceLarge animal monkey/canine ultrasound-guided liver biopsyLarge animal monkey/canine muscle biopsyRapid screening or IND support
Medicilon icon-diamond.pngSpecies
  • Mouseratguinea pigrabbitdogmini-pigcrab-eating macaque
Medicilon icon-diamond.pngAdministration Routes
  • Intravenoussubcutaneoustransdermalintramuscularintraperitonealoralsublingualnasalintravitrealintrathecal drug deliveryCassette administration
Medicilon icon-diamond.pngSampling
  • continuous microblood collection
Medicilon icon-diamond.pngSurgical Models
  • Intravenous cannulationinfusion pumpbile duct cannulation
Feature Platforms
  • The Pharmacokinetics Research of Nucleic Acid Drugs.webp

    The Pharmacokinetics Research of Nucleic Acid Drugs

    The Medicilon Liver Biopsy Guided By B-ultrasound In Cynomolgus Monkeys Platform can avoid the large blood vessels and gallbladder and has the advantages of less trauma, safe and simple puncture operation, accurate positioning, and better postoperative recovery.

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  • Pharmacokinetic Study of Cell & Gene Therapy Drugs.webp

    Pharmacokinetic Study of Cell & Gene Therapy Drugs

    The pharmacokinetc research studies sample in vivo behaviors, such as distribution, proliferation and survival time. We also track transgenic product expressed and secreted outside of the immune cells to assess its local and/or systemic exposure characteristics.

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  • The Pharmacokinetics Research of ADC Drug
    Due to molecular complexity, the PK characteristics of an ADC must be evaluated by multiple analytes. Therefore, the difficulty of analysis is increased. In in vivo assays for ADC, we have established a variety of quality testing methods for ADC component analytes. By analyzing plasma/serum samples collected from animals, we provide our clients with reliable and quality PK data.
    DeterminandDescriptionTypical analysis method
    Conjugated AntibodyAntibody conjugated to at least one drugLBA
    Total AntibodyFully conjugated, partially conjugated and unconjugated antibodiesLBA
    Small MoleculesFree or diluted drug micromolecules and their metabolitesLC-MS/MS
    ADAAntibodies that can specifically bind ADC molecules and their partial structuresLBA
Medicilon has introduced an animal in vivo PET/CT/MR molecular imaging syste. enabling complex physiological and metabolic processes in organisms to be observed. PET analysis with radio-tracer label can ensure quantitative evaluation of the pharmacokinetics and metabolism of a drug. Combined with efficacy data including ethology performance, it is possible to establish the dose-efficacy relationship and determine the dose while tracking the regional distribution of drugs in target tissues.
Medicilon icon-notebook.pngEvaluation performance
  • Our Preclinical Pharmacokinetics Department can complete approximately 1,000 single pharmacokinetic researches in vivo and 200 complete pharmacokinetic researches in accordance with the filing every year.The candidate categories we test include micromolecule drugs, bio-tech-based drugs and natural product drugs.The contents involved in evaluation include but are not limited to haemodynamics, tissue distribution, excretion  and material balance.Medicilon have a research license for radioisotopes (125I, 14 C, 3H). The license is for material balance and tissue distribution researches.
Medicilon icon-bulb.pngSoftware
  • WinNolin and WastonLim are used for calculation and processing of pharmacokinetic research data and management of analytical laboratory.
Service Cases

Medicilon Assistant| Jimincare's lgE Antibody Drug JYB1904 has been Approved for Clinical Trials.webp

Medicilon Assistant| Jimincare's lgE Antibody Drug JYB1904 has been Approved for Clinical Trials

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      Medicilon Assist| Sinovent's New Class 1 Anti-tumor Drug XNW14010 has been Approved for Clinical Trials.webp

Medicilon Assist| Sinovent's New Class 1 Anti-tumor Drug XNW14010 has been Approved for Clinical Trials

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 Medicilon Assists CGeneTech's Oral Hypoglycemic DPP-4 Inhibitor, New Drug Application (NDA) Accepted.webp

Medicilon Assists CGeneTech's Oral Hypoglycemic DPP-4 Inhibitor, New Drug Application (NDA) Accepted

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For more service cases, please contact us:

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Learn more about "In Vivo Pharmacokinetic Assays"
FAQ
  • What is Caco-2 Cell Model?

    The Caco-2 cell line is a human colon adenocarcinoma epithelial cell that can differentiate itself into a monolayer similar to a mature human small intestinal epithelial cell.


  • What are the Ideal DMPK Properties?

    (1) Complete absorption (passive absorption is better), bioavailability > 50% and small variation;

    (2) AUC is proportional to dose, and PK/PD correlation is clear;

    (3) Quickly reach the target organ and do not accumulate outside the target organ;

    (4) PPB<90%, not affected by concentration and time;

    (5) Plasma clearance CL<30%Qn, cleared through various routes;

    (6) Age, race, gender, disease state, etc. have little effect on CL;

    (7) metabolite quantity is low and no reactive metabolites are produced;

    (8) Does not inhibit or induce major drug metabolizing enzymes and transporters, and is not affected by food; 

    (9) T1/2>6hr in human body, which can reduce the dosing frequency and improve the compliance.

  • What is the Explanation for the Clearance (CL) > Hepatic Blood Flow (Qh) in the In Vivo PK Test in Animals?

    (1) The liver is the main organ of drug metabolism, but not the only way of drug elimination. There is also renal elimination, etc.

    (2) The drug is unstable in the blood, and the clearance of the drug does not have a hepatic effect.

    (3) In some cases, when the drug concentration in red blood cells is much higher than that in plasma, the calculation of proper clearance cannot be approximated by the drug concentration in plasma.

    (4) In individual cases, metabolism or uptake by the lungs occupies a significant role.


  • What Should Explain Bioavailability F > 100% in Animals' In Vivo PK Test?

    (1) Dose deviation due to administration error.

    (2) Nonlinear pharmacokinetics (Nonlinear PK).

    (3) High bioavailability and individual variability in the DMPK properties of the drug, with IV and PO, given to different groups of animals.

    (4) Overestimation of PO AUC or underestimation of IV AUC due to unreasonable sampling points.

    (5) IV samples were left for extended periods, and compounds were unstable in plasma.

    (6) When administered as a racemate, the faster-clearing enantiomer is converted to the slower-clearing enantiomer in the GI tract.


Relevant laboratories
  • Pharmacokinetics
  • Immunoassay Platform
  • Pharmacokinetic Instruments
  • isotope
  • Electrochemiluminescence instrument
  • high-speed centrifuge
  • Shimadzu UV Analyzer
  • Clinical testing equipment
  • Pharmacokinetics refrigerator
  • tissue embedding machine
  • LC-MS-MS
  • Tissue Dehydrator
  • Ultrasonic Disintegrator
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