Advancing Drug Development with PK/TK Parameter Assessment
Global full bioanalytical and PK/TK support for
all stages of drug development.
Expert support for your pre-clinical GLP
and clinical studies
Regulatory-aligned solutions for seamless drug development.
Resolian’s team of pharmacokineticists has many years of experience carrying out pharmacokinetic (PK) and toxicokinetic (TK) analysis for all stages of drug development, providing you with expertise, flexibility and quality.
Reach out to us directly to learn more about Resolian’s Statistical PK Analysis services.
Our Expertise
- Non-compartmental analysis using industry standard Phoenix WinNonlin
- Supporting all phases of development from discovery, GLP pre-clinical to clinical and bioequivalence
- Final PK/TK Reports: regulatory ready
TFLs and interpretation - Interim Safety Review Reports to support Single Ascending Dose and
Multiple Ascending Dose studies - Dedicated eCTD publishing team
CDISC-compliant SEND and SDTM datasets
Your partner
- Dedicated in-house team of PK/TK specialists
- Trusted globally by leading biopharma companies
- Fast turnaround, cost-efficient, and highly customized solutions
- Expert advice and interpretation
- Standalone service on data from any lab
- Consultative approach with personalised support for your studies
- Seamless collaboration with bioanalytical scientific teams
- Extensive experience with FDA, EMA, and ICH (M3 & S3A) guidelines
Support for Pre-Clinical and Clinical Studies
Resolian uses industry-standard Phoenix WinNonlin for non-compartmental analysis, giving you access to a complete bioanalytical and pharmacokinetic/toxicokinetic (PK/TK) service to support your pre-clinical GLP toxicology and clinical studies.
Comprehensive standard operating procedures (SOPs), validated software systems and full QA facilities ensure regulatory compliance.
Planning
Pharmacokinetic parameters, methods of calculation and specific reporting requirements are set out in a detailed GLP phase plan or analytical project plan. Plans for regulated studies are audited by Resolian’s Quality Assurance department.
Reporting
Resolian’s reports contain high-quality tables, figures and listings along with interpretation and conclusions to aid in decision-making. Resolian also offers fast-turnaround interim reporting in support of dose escalation decisions for first-in-human studies.
Standalone Service
Resolian offers a standalone service performing PK/TK analysis on data generated outside of Resolian.
Data Management
Resolian can provide data in bespoke formats to meet your exact reporting needs. Resolian’s dedicated Data Management team provides data transfers and reporting to Clinical Data Interchange Standards Consortium (CDISC) specifications for the Exchange of Nonclinical Data (SEND) and Human Clinical Data (SDTM).
