Pharmacokinetic Analysis & Reports

Compartmental and Noncompartmental Pharmacokinetic Analysis & Reports

BioAgilytix performs compartmental (model-dependent) or noncompartmental (model-independent) pharmacokinetic analysis, using validated Phoenix WinNonlin software. We produce pharmacokinetic and toxicokinetic reports to support discovery, preclinical, GLP toxicology, and clinical studies. We conduct PK simulations to predict the plasma concentration profile of a drug under various input conditions.

We also offer pharmacokinetic consulting, which includes assistance with PK study design, protocol development, and performing PK calculations for our clients.

Pharmacokinetic Data Analysis / PK Modeling

BioAgilytix specializes in conducting pharmacokinetic (PK) data analysis for discovery, preclinical, and clinical studies. We perform both compartmental (model-dependent) and noncompartmental (model-independent) analyses, using validated Phoenix WinNonlin software. We rapidly assess bioequivalence, drug exposure, DDI (drug-drug interactions), food effects on pharmacokinetics, and drug recovery data. We will also provide assessments of PK/PD relationships.

Toxicokinetic Data Analysis

For GLP toxicology studies, we perform noncompartmental analysis to establish exposure, accumulation, linearity of PK parameters, differences in sex-related exposure, and a comparison of dose-related exposure.

PK Simulations

We can use existing PK data to predict the plasma concentration profile of a drug under various input conditions. This information allows you to preview the potential effect of various routes of administration, multiple dosing regimens, and variable infusion schedules and can provide valuable insight into the design of preclinical and clinical studies.

Consulting

Our scientists have decades of drug discovery and development experience and will provide you with the advice and support necessary to help advance your pharmacokinetics programs. BioAgilytix can help design appropriate studies for pharmacokinetic analysis, perform pharmacokinetic calculations, and incorporate bioanalytical data into regulatory submissions.

Validated Software for Pharmacokinetic Analysis

BioAgilytix uses the latest version of Phoenix WinNonlin to perform PK and TK calculations, in addition to creating SEND data transfer files.

Featured Case Study

Customizing Specimen Collection Kits

Learn how customizing specimen collection kits for specific clinical trial sampling requirements streamlined our client’s Phase I study and helped ensure that all specimens collected were stabilized, properly labeled, and provided accurate pharmacokinetic data.

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