Pharmacokinetics / Toxicokinetics (PK/TK) Study Analysis

For researchers driving new drug development, thorough pharmacokinetic services (PK) and toxicokinetic services (TK) analysis is essential for understanding compound behavior and meeting regulatory requirements. An experienced PK/TK study partner provides comprehensive analytical support, allowing you to concentrate on core research while they navigate the complexities.

Whether ranking lead candidates, assessing bioavailability, examining tissue distribution, or modeling pharmacodynamics, an experienced strategic PK/TK study partner can guide your compound through nonclinical and clinical phases. Specialized expertise in analytical techniques like LC-MS/MS, LBA and Q-PCR, combined with a diverse range of animal models including disease state and surgical models, ensures you obtain high-quality, comprehensive PK/TK study analysis insights to drive your drug development program forward successfully.

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How Modern CROs Accelerate Your Drug Development
Are you facing delays, bottlenecks, or rising costs in your drug development process? In this webinar, you will learn how leading CROs overcome these challenges with innovative strategies. Gain insights that can directly impact your timelines, reduce risks, and streamline your path to approval.
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In Vivo PK/TK Studies

Researcher views data on computer At Charles River, our comprehensive knowledge and expertise on in vivo PK studies empower successful drug development. Our knowledgeable team conducts rigorous in vivo studies to provide the critical insights you need to optimize safety, efficacy, and regulatory compliance. From rank-ordering compounds to evaluating drug-drug interactions, we offer a comprehensive suite of tailored PK/TK services. Leveraging state-of-the-art analytics and specialized models, we explore crucial ADME parameters and deliver the robust data required to advance your molecules through preclinical to clinical stages. Our wide range of In Vivo ADME studies cover important aspects such as:

  • Blood brain barrier
  • Toxicokinetics
  • Anti-drug antibodies
  • Pharmacodynamic and pharmacokinetic/pharmacodynamics modeling
  • Input into study design, including preclinical-to-clinical consideration

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PK/TK Study Administration Routes and Collection

Researcher collects sample We take a meticulous approach to your PK studies. Our specialized administration routes and sampling protocols are essential for obtaining reliable, time-course data to power your drug development programs. With tailored methodologies spanning single agents to cassette dosing, and routes from oral to subcutaneous, we deliver the solutions you need to optimize results. Leveraging our expert-designed solutions, you can be confident in the quality and insights driving your molecule forward. Our capabilities include:

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Bioanalytical Strategies Unlocked: Innovative Approaches to PK, Immunogenicity, and Biomarkers
In this webinar, our scientific experts will walk you through real-world case studies that illustrate how innovative bioanalytical approaches can help you overcome common hurdles in pharmacokinetics (PK), immunogenicity, and biomarker applications.
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Disease State and Surgical Models in PK/TK Studies

Scientists performing surgery in surgery room Disease State and Surgical models are critical for evaluating valuable insights into drug interactions, effects, and disease etiology in a controlled, realistic setting. Our advanced techniques enable precise administration and data collection, ensuring high-quality PK/TK studies. Our diverse range of disease state portfolios and surgical models provide you with the tools you need to accurately assess the impact of drugs on physiological systems. By employing these sophisticated methods, we replicate conditions that closely resemble clinical settings, enhancing the reliability and validity of our research findings.

PK Study Analysis and Support at Your Fingertips

With unparalleled PK/TK analysis expertise and specialized capabilities, Charles River is uniquely positioned to power your drug development by accessing your study insights in real-time data with Apollo™. When you partner with us, you gain a trusted, experienced guide through the complexities of PK/TK analysis. Our specialized team of scientists are esteemed subject matter experts, leveraging advanced analytical techniques, and tailored in vivo study designs to uncover the critical insights you require.

Whether you're navigating the intricacies of bioavailability and dose proportionality or exploring the challenges of drug-drug interactions and tissue distribution, we have the expertise to chart the optimal path forward. Reach out to our PK/TK study specialists today and let us demonstrate how our comprehensive capabilities can accelerate your drug’s development and drive it closer to the finish line.

Speak with PK/TK Experts

Human antibodies, immunoglobulin proteins, Immune system. 3D rendering

A Strategic Approach to Nonclinical Anti-Drug Antibody Assessment
Katherine Malone, Associate Director of Research, presents a leaner strategic approach to anti-drug antibody (ADA) assessments to support nonclinical toxicology studies.
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Frequently Asked Questions (FAQs) About Pharmacokinetics and Toxicokinetics (PK/TK) Services

  • What is the difference between pharmacodynamics and pharmacokinetics?

    While pharmacodynamics is the study of how drugs interact with the body and produce a response, pharmacokinetics focuses on how the body affects the drug - specifically, how it is absorbed, distributed, metabolized, and eliminated. In simpler terms, pharmacodynamics looks at what a drug does to the body, while pharmacokinetics looks at what the body does to a drug. Our PK/TK Analysis service combines both aspects, providing comprehensive data on how a drug moves through and interacts with the body, ultimately helping scientists design more effective and safe treatments for various diseases. With our experienced team and cutting-edge technology, we are able to conduct studies that examine multiple parameters in support of regulatory submissions. We utilize various analytical techniques such as radioassay, LC-MS/MS, HPLC, CE, Ligand Binding Assays, and more to provide accurate and reliable results. Additionally, our service also offers toxicokinetic assessments that can be conducted alongside ongoing toxicology studies for a more complete understanding of a compound's effects on the body.

  • How can PK/TK analysis services support regulatory submissions?

    We understand the importance of thorough and accurate data in order to support regulatory submissions. That's why our experienced scientists are dedicated to designing and conducting PK studies that examine multiple parameters using a range of analytical techniques, such as radioassay, LC-MS/MS, HPLC, CE, Ligand Binding Assays, and more. We also offer toxicokinetic assessments that can be conducted concurrently or in parallel with ongoing toxicology studies. This comprehensive approach ensures that your data is robust and meets all necessary regulatory standards, giving you peace of mind and confidence in your submissions. Our PK/TK analysis services are tailored to meet the specific needs of each project and provide reliable results for successful regulatory approvals.

  • What are the four categories of pharmacokinetics?

    The four main categories of pharmacokinetics, also known as PK, are absorption, distribution, metabolism, and elimination. These key parameters are crucial to understand how a drug is absorbed into the body, how it is distributed throughout the body, how it is metabolized or broken down by the body's enzymes, and how it is eliminated or removed from the body through urine or feces.

  • What analytical capabilities are available to support PK/TK?

    By conducting PK studies using various analytical techniques our experienced scientists at Charles River can provide valuable PK/TK study data on these parameters for regulatory submissions. Additionally, our team also offers toxicokinetic services to examine how a drug interacts with and affects the body's toxicology in parallel with ongoing toxicology studies. With our advanced methods and thorough analyses, you can trust us to provide accurate and comprehensive PK/TK services for your research needs.

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