Pharmacokinetic (PK) and toxicokinetic (TK) studies evaluate how a compound behaves in the body over time. Both use principles of absorption, distribution, metabolism, and excretion (ADME) of a drug: pharmacokinetics considers what the body does to the drug; toxicokinetic studies consider what the body does to the drug at higher doses (systemic exposure) to support safety evaluation.
Together, PK/TK analysis provides critical insights for determining dosing strategies, evaluating drug exposure, and generating the data required for regulatory submissions throughout the drug development lifecycle.
PK/TK analysis supports the following goals:
Alturas Analytics delivers pharmacokinetic and toxicokinetic services that assist small-molecule and biologic development pipelines. Our study support includes:
Our integrated workflow ensures consistent communication, robust data handling, and reliable timelines. By pairing our bioanalytical and PK/TK services, your samples are seamlessly analyzed and reported by a collaborative team of experts.
Our combined PK team has over two decades of experience.
At Alturas, we foster a collaborative environment with our sponsors to ensure your data stands up to regulatory inspection.
Alturas Analytics provides comprehensive pharmacokinetic and toxicokinetic (PK/TK) analysis services to support both preclinical and clinical drug development programs. Our scientists transform bioanalytical concentration data into meaningful PK/TK parameters that guide decision-making across the drug development lifecycle, from early discovery through regulatory submission.
Both PK and TK analysis characterize drug ADME (absorption, distribution, metabolism, and excretion); PK considers what the body does to the drug, while TK analysis evaluates systemic exposure by applying pharmacokinetic principles to toxicology studies to support safety assessment. Together, these analyses provide a complete understanding of drug exposure, enabling informed decisions around dosing strategies, safety margins, and regulatory readiness.
Alturas delivers PK/TK analysis as a standalone service or as part of an integrated bioanalytical workflow for both small and large molecules. Using validated WinNonlin® software and supported by our in-house Quality Assurance Unit, we ensure all analyses meet regulatory expectations. When combined with bioanalytical services, this integrated approach improves data consistency, streamlines communication, and accelerates timelines for audited, submission-ready reporting.
Our PK/TK capabilities include:
Through this combined PK/TK expertise, Alturas helps sponsors generate reliable, regulatory-ready data that supports confident decision-making and successful progression through development milestones.
Toxicokinetic (TK) analysis evaluates systemic drug exposure during toxicology studies and helps determine the relationship between dose levels and observed safety findings. These insights are critical for understanding how exposure correlates with toxicity and for establishing safe dose ranges during drug development.
Alturas Analytics conducts GLP-compliant TK analysis of samples and/or data collected from both rodent and non-rodent species, supporting regulated safety and toxicology studies. By generating reliable exposure data across study conditions, our TK services help sponsors assess safety margins, interpret toxicology results, and support regulatory submissions.
Through integration with bioanalytical testing and pharmacokinetic analysis, Alturas ensures consistent, high-quality data that supports confident decision-making in both preclinical and regulatory environments.
Alturas Analytics supports a wide range of pharmacokinetic and toxicokinetic (PK/TK) study designs across both preclinical and clinical development. PK/TK analysis can be performed as a standalone service or integrated with bioanalytical testing, utilizing non-compartmental analysis (NCA) to evaluate both regulated and non-regulated study formats.
Our team works closely with sponsors to design studies that generate reliable exposure and safety data aligned with development and regulatory objectives.
A typical PK/TK project at Alturas Analytics follows a structured, collaborative workflow designed to ensure data quality, regulatory alignment, and efficient study execution:
This integrated workflow ensures clear communication, consistent data handling, and reliable results throughout the study lifecycle.
The PK/TK services at Alturas Analytics maintain regulatory standards for submitting documentation to the U.S. FDA, EMA, and other relevant global regulatory authorities.
Alturas supports regulated studies through:
Additional support includes:
For clinical studies, SDTM (study data tabulation model) PC and PP domains may be provided to support regulatory submissions. The standard for exchange of nonclinical data (SEND), including pharmacokinetic concentration (PC) and pharmacokinetic parameter (PP) domains, is available for integration into complete nonclinical submission packages.
Working with a CRO requires evaluation of multiple aspects, including identifying project requirements and operational details. The same principles of open communication and on-time delivery that define our LC-MS, LC-HRMS, and GC-MS bioanalytical services apply to every experience. Our PK experts work on the same site as our bioanalytical laboratory scientists. Alturas Analytics maintains a zero-silo culture with open lines of communication so that we maintain direct availability for you and respond to all questions during your study.
The Alturas PK team will guide you through each stage of your study.
Yes. Regulated PK and TK analysis performed at Alturas meets all 21 CFR Part 58 GLP requirements to assure the quality and integerity of the data and reports produced. We ensure complete documentation, quality assurance oversight, and are always audit ready.
The laboratory performs drug concentration analysis of plasma, serum, urine, whole blood, cerebrospinal fluid (CSF), bile, saliva and tissue homogenates in both research and clinical environments. Talk to one of our bioanalytical experts if you have other matrices of interest.
We offer standalone PK analysis services, utilizing concentration datasets generated by external vendors. There is no limitation on matrices for these concentration datasets.
While we do not perform metabolite identification analysis, our laboratory establishes and verifies LC-MS/MS techniques to quantify parent compounds together with their metabolites at levels suitable for metabolic characterization. Our PK team routinely handles such studies, aiding in identify disproportionate drug metabolite(s).
Project approval determines the start time of new studies because method development requires 2–4 weeks after approval. If you are providing bioanalytical data from an outside laboratory, PK/TK analysis will typically begin within a week of a signed quote and receipt of data. Expedited PK/TK services are available upon request.
How prepared are you to move your program forward and how trustworthy is your PK/TK data?
Schedule a consultation to discuss your study objectives with one of our a senior scientists!
Sara is the Senior Pharmacokineticist at Alturas Analytics, Inc. Sara has over 20 years of experience in the biotechnology and pharmaceutical industry after graduating with a B.S. in Genetics and Cell Biology.
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