BOC Sciences provides comprehensive pharmacokinetic testing solutions to support pharmaceutical drug development and discovery. Utilizing advanced technologies, we perform detailed ADME (Absorption, Distribution, Metabolism, Excretion) profiling to help optimize drug formulations and predict pharmacokinetic behavior in biological systems. Our services deliver precise and reliable data that support critical decisions across the development pipeline. With expertise in workflow customization and platforms such as LC-MS/MS, combined with robust in vitro models, we generate rapid and actionable insights tailored to your project needs. From early-stage research through to final formulation studies, we streamline the development process and enhance decision-making efficiency.
Pharmacokinetic testing plays a vital role in new drug development by providing essential insights into how a compound behaves within the body. It informs key aspects such as formulation optimization, dosing strategies, and identification of potential safety or efficacy concerns at an early stage. PK testing also enables the prediction of in vivo behavior based on preclinical data, supporting effective study design and compound selection. Detecting challenges such as poor bioavailability or rapid clearance early in the process allows for timely adjustments, ultimately helping to improve development outcomes and reduce risk across the drug pipeline.
Our experienced PK team designs customized studies, providing expert support across drug classes to ensure robust and reliable data generation.
Equipped with LC-MS/MS, HPLC, GC-MS, and flow cytometry, we offer high-sensitivity, precise, and reproducible analysis for complex pharmacokinetic evaluations.
We support diverse drug modalities including small molecules, biologics, vaccines, gene therapies, and inhalation drugs, meeting varied project demands.
Our full-scale platforms include Caco-2, liver microsomes, and GLP-compliant animal studies for accurate ADME profiling across all development stages.
We tailor administration routes, species selection, and sampling schedules, ensuring project-specific pharmacokinetic testing with scientific rigor.
From method development to data interpretation, we deliver integrated PK solutions that accelerate timelines and streamline drug development workflows.
BOC Sciences provides essential PK and ADME testing services to support early-stage drug development. Our validated in vivo and in vitro assays deliver critical insights into the ADME properties of drug candidates, helping to optimize dosing strategies and predict drug behavior in humans. These services are particularly suitable for small molecule inhibitors, biologics, vaccines, and other traditional drug types, enabling accurate pharmacokinetic profiling and facilitating effective therapeutic development.
Quantifies the fraction of the administered drug reaching systemic circulation, essential for evaluating oral dosage forms and guiding formulation development.
Measures the time at which the drug reaches peak plasma concentration, indicating the rate of absorption and supporting pharmacodynamic modeling.
Reflects the highest observed plasma drug concentration post-administration, contributing to assessments of exposure and potential therapeutic or toxic effects.
Provides a theoretical volume that a drug would occupy if evenly distributed, used to infer tissue penetration and guide safety margin estimation.
Profiles primary and secondary metabolites using LC-MS/MS or radiolabeled approaches to support structural elucidation, MIST evaluation, and cross-species comparison.
Assesses intrinsic clearance using liver microsomes or hepatocytes from human and preclinical species, aiding in prediction of metabolic liability and systemic clearance.
Determines the volume of plasma cleared of drug per unit time, serving as a core parameter in pharmacokinetic modeling and dose prediction.
Estimates the time required for plasma concentration to decrease by 50%, critical for defining dosing intervals and assessing accumulation risk.
At BOC Sciences, we provide a wide array of advanced in vitro and in vivo models to support comprehensive pharmacokinetic (PK) testing and drug development. Our robust platform includes classic cell lines, stem cells, organoid models, and disease-specific animal models, all designed to predict human drug behavior, metabolism, and toxicity more accurately. With standardized systems and professional techniques, we assist our clients in everything from mechanism studies to efficacy evaluations, ensuring efficient and reliable support for the entire drug development process.
| Model Type | Representative Examples |
| Cell Models | Caco-2 cells simulate intestinal absorption, HepG2 and primary hepatocytes assess drug metabolism and hepatotoxicity, MDCK cells evaluate drug transport. |
| Artificial Membrane Permeability Models | PAMPA predicts passive drug diffusion, organ chips (liver, intestinal) mimic human organ responses for drug metabolism and absorption. |
| In Vitro Metabolic Systems | Liver microsomes and recombinant enzymes like CYP3A4, CYP2D6 assess drug metabolism, stability, and metabolic pathways. |
| Model Type | Representative Examples |
| Rodent Models | Mice and rats used to study oral bioavailability, tissue distribution, and metabolic differences using gene-edited models like CYP450 knockouts. |
| Non-Rodent Models | Beagle dogs evaluate cardiovascular safety and human-like metabolism, including specific drug pathways like CYP2D6. |
| Zebrafish Models | Zebrafish models study developmental toxicity and visualize drug distribution using fluorescently labeled compounds. |
BOC Sciences is equipped with state-of-the-art instrumentation platforms that enable us to offer precise and reliable pharmacokinetic testing services. Our advanced technologies allow us to perform detailed analyses of drug concentrations, ADME properties, which are crucial for the development of novel therapeutic candidates. By utilizing cutting-edge platforms such as LC-MS/MS, HPLC, and GC-MS, we can ensure high sensitivity, reproducibility, and accuracy in our testing results. These technologies are designed to meet the needs of diverse drug types, including small molecules, biologics, and gene therapies. With a commitment to delivering comprehensive, high-quality data, BOC Sciences supports clients in optimizing their drug development processes and advancing therapeutic innovations.
| LC-MS/MS System | GC-MS |
| HPLC | Flow Cytometry |
| Radioactive Isotope Labeling | Drug Dissolution Testing Equipment |
PK testing of vaccines focuses on delivery systems (e.g., lipid nanoparticles), immune response, antibody titers, and antigen persistence. It emphasizes the performance of delivery systems and immune reaction over traditional ADME properties.
Monoclonal antibody PK testing examines target-mediated drug disposition (TMDD), FcRn-mediated circulation, and the impact of anti-drug antibodies (ADAs) on drug clearance, along with tissue penetration and tumor distribution.
PK testing of inhalation formulations evaluates pulmonary deposition, first-pass metabolism, bioavailability, and consistency in dosing through various devices (e.g., DPIs, MDIs) to ensure optimal drug delivery and effectiveness.
PK testing for cell therapies focuses on cell survival, proliferation, and migration. It tracks distribution, immune-mediated clearance, and long-term effects using techniques like flow cytometry and qPCR to monitor therapeutic cell localization.
ADCs PK testing involves evaluating the antibody and toxin components separately, with an emphasis on tumor-to-plasma ratios, tissue penetration, drug release mechanisms, and potential systemic toxicity.
AAV PK testing includes assessing tissue distribution, particularly in the liver and neural tissues, tracking vector retention, and considering immune clearance effects, requiring long-term follow-up to monitor potential risks like vector integration.
PK testing for oligonucleotides involves evaluating stability, tissue distribution, and accumulation in organs like the liver and kidneys. Delivery systems, degradation, and metabolic pathways are key considerations in the testing process.
PK testing for lipid-based systems focuses on clearance, tissue accumulation, and targeting effects. It evaluates stability, drug release kinetics, and potential immunogenicity, ensuring effective delivery and minimal toxicity.
Study Design
Define the study objectives, animal models, dosage levels, administration routes, sampling time points, and biological matrices based on the drug's characteristics.
Dosing Administration
Administer the test compound via appropriate routes (e.g., oral, intravenous, subcutaneous) following the established protocol.
Sample Collection
Collect biological samples such as blood, plasma, urine, or tissues at predetermined intervals to capture drug concentration over time.
Bioanalytical Testing
Analyze the samples using validated platforms like LC-MS/MS or HPLC to quantify the drug and its metabolites with high accuracy and reproducibility.
Data Analysis and PK Parameter Calculation
Use pharmacokinetic software (e.g., WinNonlin) to derive key PK parameters such as Cmax, Tmax, AUC, and T1/2, and to generate concentration-time profiles.
Interpretation and Reporting
Interpret the results to understand the drug's in vivo behavior and compile comprehensive reports to support formulation development and further research decisions.
We offer PK testing services applicable to a wide range of drug types, covering compounds with diverse structural features and delivery mechanisms. With flexible study designs and versatile analytical platforms, we tailor testing strategies based on the specific characteristics of each compound. Our services help clients comprehensively evaluate the ADME profiles, providing strong data support for efficacy optimization and project advancement.
| Drug Type | Example |
| Small Molecule Inhibitors | Kinase inhibitors (e.g., for non-small cell lung cancer), chemotherapeutic agents (e.g., paclitaxel for breast cancer) |
| Vaccines | mRNA vaccines (e.g., COVID-19), adenoviral vector vaccines (e.g., Ebola virus vaccine) |
| Biologics | Monoclonal antibodies (e.g., adalimumab for rheumatoid arthritis), ADCs (e.g., for HER2-positive breast cancer) |
| Gene Therapies | AAV-based therapies (e.g., for spinal muscular atrophy), mRNA therapies (e.g., for rare genetic disorders) |
| Inhalation Formulations | Inhaled corticosteroids (e.g., for asthma), inhaled antibiotics (e.g., for cystic fibrosis infections) |
What is a PK test in drug development?
A PK (pharmacokinetic) test measures how a drug is absorbed, distributed, metabolized, and excreted (ADME) in the body. It helps evaluate drug exposure, bioavailability, and optimal dosing.
Why is pharmacokinetic testing important in early drug development?
PK testing provides critical data to predict human responses, optimize dosing regimens, identify safety concerns, and guide compound selection—helping reduce late-stage failures.
What types of drugs require PK testing?
Most drug types, including small molecules, monoclonal antibodies, vaccines, gene therapies, and inhalation formulations, require PK testing to assess in vivo behavior and therapeutic potential.
What methods are used in PK testing?
Common PK testing methods include in vivo animal studies, in vitro assays (e.g., microsomes, Caco-2 cells), and advanced analytical tools like LC-MS/MS, HPLC, and flow cytometry.
