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PK /PD & Clinical Pharmacology

This service suite forms the core of quantitatively evaluating a drug’s fate in the body, playing a pivotal role in determining the optimal dose, effective regimen, and safety profile of a novel therapeutic. We meticulously track and analyze drug concentration changes in blood and tissues over time to extract critical pharmacokinetic parameters. This data is not only essential for establishing fundamental pharmacological principles but also provides the scientific foundation for designing clinical trialsdetermining human doses, and understanding the concentration-effect relationship (PK/PD). These services are specifically designed for new chemical entities, nano-formulations, peptides, proteins, and monoclonal antibodies.

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    Veterinary Industry Innovation

    1

    Core PK/TK Assessment Framework

    This fundamental assessment is the first systematic study to understand a drug’s fate in the body, with the goal of determining the initial exposure profile and drug elimination parameters. Conducted in the early drug discovery and preclinical stages on selected candidates, it provides the scientific basis for dose selection in efficacy and toxicity studies. Its output is a set of key quantitative values that describe the drug’s behavior and enable the prediction of initial human doses.

    Single-Dose PK

    • 6–10 timepoints
    • Whole blood collection → plasma separation
    • ELISA or LC–MS/MS analysis
    • Complete PK profiling: Cmax, Tmax, AUC, t½, Clearance

    Multi-Dose / Steady-State PK

    • PK Day 1 + PK Final
    • Accumulation analysis
    • Steady-state exposure metrics
    • Multi-dose elimination curves
    Veterinary Industry Innovation

    2

    PK Sampling Timepoint Design & Optimization

    The objective of precise PK sampling timepoint design is to fully capture the drug’s concentration-time profile in the body, enabling the reliable calculation of all key pharmacokinetic parameters. This service is essential for drug discovery researchers and preclinical teams who require efficient study design and generation of robust data for critical decision-making, such as dose selection. The deliverable is an optimized, customized sampling schedule tailored to the specific characteristics of your compound (e.g., half-life). It ensures that data collected on Day 1 (PK Day 1) fully characterizes initial absorption and distribution, and data at the study termination (PK Final) reliably assesses drug accumulation or steady-state changes. A standard multi-phase sampling schedule typically covers these critical time points:

    • PK Day 1: Pharmacokinetic assessment following the first administered dose.
    • PK Final (End of Study): Pharmacokinetic assessment at the conclusion of the dosing regimen.
    • PK sampling schedule with multi-phase coverage:

    • 0 min (Baseline)
    • 5 h (Rapid Absorption)
    • 1 h (Peak Absorption)
    • 2 h (Distribution)
    • 4 h (Transition)
    • 8 h (Initial Elimination)
    • 24 h (Elimination)

    Additional points depending on drug half-life

    Veterinary Industry Innovation

    3

    Bioanalytical Platforms & Methods

    Modality-Specific Detection Platforms

    Our analytical core deploys platform-specific, gold-standard techniques to deliver accurate and reliable quantification of your therapeutic agent, regardless of its molecular class. For proteins, peptides, and biologics, such as GLP-1 analogs, growth hormone, insulin, and monoclonal antibodies (mAbs).

    1. we utilize highly specific Enzyme-Linked Immunosorbent Assay (ELISA) methods optimized for complex plasma matrices.
    2. For small molecule drugs and metabolites, we employ state-of-the-art Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), offering unparalleled sensitivity (reaching pg/mL levels), selectivity, and a broad dynamic range to characterize even the most challenging compounds.

    This dual-platform expertise ensures that your PK data is built on a foundation of analytical rigor, meeting the highest standards for preclinical and translational research.

    Veterinary Industry Innovation

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    Primary PK Objectives

    These five key parameters form the backbone of every pharmacokinetic study, providing the fundamental data needed to understand a drug’s behavior in the body. Their accurate calculation is essential for defining the complete exposure profile and predicting a drug’s performance in later development stages. Together, they deliver a comprehensive quantitative drug profile used directly in preclinical reports, regulatory filings (e.g., IND), clinical trial design, and strategic development decisions, serving as the critical bridge between lab observations and predictions of human performance.

    1. Cmax (Peak Concentration):The highest drug level in blood, indicating peak exposure intensity for assessing efficacy and toxicity risk.
    2. Tmax (Time to Peak):Time to reach Cmax, reflecting absorption speed and critical for optimizing formulation and dosing schedule.
    3. AUC (Total Exposure):The total drug exposure over time, the gold standard for calculating bioavailability, clearance, and exposure-response relationships.
    4. t½ (Half-Life):Time for drug concentration to halve, determining dosing frequency, time to steady-state, and drug accumulation potential.
    5. Clearance:Volume of blood cleared of drug per unit time, measuring the body’s elimination efficiency and essential for human dose prediction and safety assessment.
    Veterinary Industry Innovation

    5

    PK–PD Modeling & Simulation

    The Quantitative Engine for Rational Dosing

    This advanced service establishes the critical, predictive link between a drug’s exposure (PK) and its biological effect (PD). We build sophisticated mathematical models that integrate time-course concentration data with biomarker or therapeutic response data, creating a quantitative framework that describes how the drug’s effect depends on its concentration in the body. This transforms raw data into a powerful predictive tool, allowing us to simulate how changes in dose, regimen, or patient population will impact efficacy and safety outcomes. The result enables truly data-driven development decisions, optimal dosing strategies, and de-risked clinical trial design.

     Key Applications & Strategic Value:

    • Optimal Dose & Regimen Selection: Identifies the dose that maximizes therapeutic effect while minimizing risk, moving beyond trial-and-error.
    • Prediction of Human Efficacy: Uses preclinical PK-PD relationships to simulate and predict effective dosing in human trials, de-risking early clinical development.
    • Clinical Trial Design Optimization: Informs efficient trial protocols by predicting the most informative dosing groups and sampling timepoints.
    • Mechanism Understanding: Helps differentiate between direct drug effects and adaptive biological responses.
    Veterinary Industry Innovation

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    Biodistribution & Tissue Mapping Studies

    This service maps precisely where a drug travels in the body, determining if it reaches its target effectively and if it accumulates in unsafe levels in other organs. This insight is crucial for designing targeted therapies, assessing tissue-specific safety, and validating the drug’s mechanism of action. We use advanced methods to create a quantitative map of drug distribution.

    These studies form the essential link between blood concentration data and effects in specific tissues, making them indispensable for the smarter, safer development of drugs in oncology, nanomedicine, and targeted therapy.

    Advanced Method Categories:

    1. Quantitative Tissue Distribution Analysis via LC-MS/MS
      The gold-standard method for precise measurement of drug or metabolite concentration in homogenized tissues (e.g., liver, kidney, tumor).
    2. Visual Tracking via Fluorescence-Based Methods
      For drugs or nanocarriers with fluorescent labels, this method enables direct imaging and visualization of drug accumulation at the tissue or even cellular level. It is invaluable for time-course studies and proving target tissue delivery.
    3. Elemental Tracking of Nanoformulations via ICP-MS
      The method of choice for nanoparticles containing specific metallic elements (e.g., gold, silver, iron) or nanocarriers loaded with metal-based drugs. Inductively Coupled Plasma Mass Spectrometry (ICP-MS) detects even trace amounts of an element in tissues with unmatched sensitivity.