Pharmacokinetic and Toxicokinetic (PK/TK) Services for Drug Development

PK/TK studies function as essential elements for evaluating drug safety and efficacy across the stages of drug development from discovery to post-marketing clinical trials.

PK/TK analysis supports the following goals:

• Drug distribution to tissues
• Dose proportionality
• Assessment of drug exposure in naïve animals or in animal models
• Changes in exposure with concomitant drugs

End-to-End PK/TK Study Support

Alturas Analytics delivers pharmacokinetic and toxicokinetic services that assist small-molecule and biologic development pipelines. Our study support includes:

• Strategic guidance regarding study design for exploratory and regulatory submissions
• Dose proportionality, exposure assessment, anti-drug antibody assessments incorporated into PK conclusions

Our integrated workflow ensures consistent communication, robust data handling, and reliable timelines. By pairing our bioanalytical and PK services, your samples are seamlessly analyzed and reported by a team of experts.

Specialized Expertise for Drug Metabolism and Exposure Analysis

Our combined PK team has experience exceeding two decades.

• First-in-human (FIH), single ascending dose (SAD), and multiple ascending dose (MAD) studies
• GLP-compliant TK studies in rodent and non-rodent species
• PK support for discovery, preclinical, and clinical programs

At Alturas, we foster a collaborative environment with our sponsors to ensure your data stands up to regulatory inspection.

Alturas Analytics PK/TK Services

Alturas Analytics provides PK/TK analysis in conjunction with our bioanalytical services, or as an independent service for small and large molecules. Using validated WinNonlin®, we produce PK/TK parameters and maintain regulatory compliance through our in-house Quality Assurance Unit. When bioanalytical services merge with PK/TK services, we are able to deliver a complete GLP-compliant analytical package of unmatched integrity, shortening the turnaround time required for audited draft report delivery.

Our team of PK experts will transform your data into meaningful conclusions so that you can develop strategic plans for your drug’s development lifecycle.

The following PK/TK services are provided by Alturas:

• Non-compartmental analysis
• Single/multi-dose study design
• Co-administered drug(s)
• Parent and metabolite evaluation
• Submission-ready reports (eCTD compliant)
• Templated reports with option to customize
• Quality control review of PK analysis and reports
• Audited draft reports for regulated studies
• SDTM/SEND datasets and supporting documentation for integration with final CDISC submission packages

Study Types and Support for Preclinical and Clinical Trials

The PK analysis at Alturas Analytics functions as a standalone service or as part of our bioanalytical services. The analysis utilizes Non-compartmental Analysis (NCA) to evaluate various regulated and non-regulated study formats.

Preclinical Study Designs:

• Single/Multiple Dose for all routes of administration
• Cross-over (Latin Square Design)
• Oral formulation
• Safety and tolerability
• Special populations and animal models (e.g., transgenic mice)

Clinical Study Designs:

• Single Ascending Dose (SAD)
• Multiple Ascending Dose (MAD)
• Cross-over Design
• Dose-Proportionality

Regulatory Readiness and GLP Compliance

The PK/TK services at Alturas Analytics maintain regulatory standards for submitting documentation to FDA, EMA, and worldwide regulatory bodies. We offer:

• Guidance on study protocol design aligned with regulatory requirements including ICH, OECD, and GLP or GCP
• On-site sample life-cycle management ensures traceability of storage conditions for impact on PK analysis for clinical and non-clinical studies
• Data archiving and reporting
• Regulatory support throughout the IND, NDA, or BLA lifecycle

The Standard for Exchange of Nonclinical Data (SEND) with pharmacokinetic concentration (PC) and pharmacokinetic parameter (PP) domains are available for the in-life facility to integrate into the complete SEND package submission to regulatory authorities. For Clinical studies, SDTM PC and PP domains may be requested.

Direct Access to Alturas Analytics PK Experts

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 which define our LC-MS, HRMS, and GC-MS bioanalytical services apply to every experience. The PK experts at Alturas Analytics maintain direct availability to respond to all questions during your study while keeping communication open with bioanalytical laboratory scientists who work on site.

The Alturas PK team will guide you through each stage of your study.

• Open communication, including concerning study events that may impact data
• Acquisition of bioanalytical data
• Transformation of the data and data review
• Performance of noncompartmental analysis and post-hoc analysis
• Creation of relevant tables and figures
• Reporting for clinical and nonclinical studies

Why Sponsors Trust Alturas Analytics for PK/TK Studies

• Dedicated project coordinators and experienced principal investigators
• Transparent timelines and proactive communication
• Small-company agility with enterprise-grade infrastructure
• Seamless integration of services with method development and bioanalytical testing

Request a PK/TK Consultation

Are you prepared to move your program forward using trustworthy PK/TK data?

You can schedule a consultation to discuss your study objectives with a senior scientist.

Explore More

Bioanalytical Services

LC-MS/MS Services

Method Development and Validation

Presentation: Pharmacokinetic Analysis