Pharmacokinetics (PK)
Understanding Pharmacokinetics (PK) and why DMPK in NHP matters
Pharmacokinetics (PK) is the quantitative study of how a drug is absorbed, distributed, metabolized, and excreted by the body. It involves applying mathematical principles to describe the time-dependent changes in drug concentration within an organism. PK studies are crucial for determining the mechanisms of a drug's absorption, biodistribution, metabolism, and elimination. These studies are integral to drug development as they provide essential data for evaluating preclinical pharmacology and safety.
Biologics deliver great benefits to patients with chronic and/or severe diseases thanks to their strong specificity to the therapeutic target. As a result of this specificity, non-human primates (NHP) are often the only preclinical species in which therapeutic antibodies cross-react with the target. PK data generated in NHPs are integrated with in vitro information to predict the concentration/effect relationship in human, and therefore translate the doses to be tested in first-in-human trials. The similarities in the systems defining the pharmacokinetics and pharmacodynamics (PKPD) of biologics in NHP and human greatly enhanced potential of the preclinical investigations.
What Specialty Values Prisys Could Offer in NHP PK/PD?
Choose Prisys Biotech for reliable, accurate, and comprehensive in vivo PK studies that support your drug development needs.
Integrated In Vivo PK Approaches
- Our seamless integration within discovery research provides flexibility and efficiency for diverse in vivo profiling demands.
Expertise in DMPK
- We offer a thorough understanding of drug metabolism and pharmacokinetics, supporting early-stage drug development.
PK studies in various animal species
- Non-human primates(Cynomolgus macaques)
- Dogs / Mini pigs
Organ-targeted Drug Delivery Platform, for the enhancement of local concentration of targeted therapeutics in NHP
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Airway exposure and intratracheal delivery: check more detail at link (Biosafety Research )
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BBB-bypassing and Precise brain administration: check more detail at link (iMRI Brain Delivery )
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Minimal-invasive organ perfusion under Digital Subtraction Angiography (DSA): check more detail at link (Clinical Imaging )
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Other specialized dosing routes: intrathecal, intra-ocular, imager-facilitated, microscopic
Extensive experiences and expertise in handling comprehensive in-life NHP Biofluids/tissues sampling
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Ultrasound-guided tissue biopsy: Liver, Kidney
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Endoscopic Biopsy: BALF, Intestine/stomach mucosal
Minimal-invasive: skin, muscle, adipose
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Catheterized biofluids: CSF, Endovascular blood (e.g. from hepatic arteries)
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Wedge-biopsy by sterile surgery: liver, kidney, lung, spleen
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Brian soft tissue biopsy: via iMRI Brain Navigation
Diverse Analytical Experiments
- Drug Metabolism: LC-MS, Radio-isotope labeling
- Immunogenicity: Flow cytometry, ADA, ELISpot
- Biomarkers: Blood/urine tests, ELISA, qPCR
- Pathology Lab: Histopathology, IHC
Kidney biopsy and IHF forC3 in IgAN Model
Prisys Biotech is dedicated to supporting your drug development journey with reliable and efficient PK study services. Reach out to us today to learn more about how we can assist you in achieving your research goals.
What is Pharmacokinetics (PK)?
Pharmacokinetics (PK) focuses on understanding how a drug interacts with a living organism. Specifically, it examines the processes of absorption, distribution, metabolism, and excretion (ADME) of drugs. In vivo PK studies are essential for ensuring that drug candidates possess suitable pharmacokinetic properties that can be evaluated in preclinical studies. These studies provide valuable information, including human equivalent doses (HED), no effect levels (NOEL), and pharmacokinetic/pharmacodynamic (PK/PD) drivers. Key PK parameters such as area under the curve (AUC), clearance, half-life, volume of distribution, maximum concentration (Cmax), and minimum concentration (Cmin) are determined through these studies.
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