PK Assay Analysis and Reports
Compartmental and Noncompartmental (NCA) Pharmacokinetic Analysis & Reports
BioAgilytix performs compartmental (model-dependent) and noncompartmental (NCA; model-independent) pharmacokinetic (PK) analysis for small molecules, biologics, and biosimilars throughout the drug development process. We use the latest validated version of Phoenix WinNonlin software. We prepare PK and toxicokinetic (TK) reports to support discovery, preclinical, GLP toxicology, and clinical studies. We conduct PK simulations to predict the plasma concentration profiles and PK parameters under various input conditions.
We also offer pharmacokinetic consulting, which includes assistance with PK study design, protocol development, and performing PK calculations.
Pharmacokinetic Analysis / Modeling
BioAgilytix is specialized in conducting pharmacokinetic (PK) data analysis for discovery, preclinical, and clinical studies for small molecules, biologics, and biosimilars throughout the drug development.
Assess bioequivalence, drug exposure, single ascending doses (SAD, Phase 1a) and multiple ascending doses (MAD, Phase 1b), drug-drug interactions (DDI), First-in-human (FIH) clinical trials, the effects of food, formulations, diseases, age, hepatic impairment, renal impairment, and other covariates on pharmacokinetics. Support Phase 1 / 2 PK, and drug recovery data and assessment of PK/PD relationships.
Toxicokinetic Data Analysis
Performs noncompartmental TK analysis (NCA) for GLP (i.e., regulated) toxicology studies such as single and repeated dose toxicity studies, safety pharmacology studies, chronic toxicity, carcinogenicity, genotoxicity, and reproductive, and developmental toxicity. Evaluate the extent of exposure, accumulation, PK linearity, sex-related exposure, dose-related exposure, and prepare regulatory compliant SEND PC and PP. We also provide TK assessment for the un-regulated studies (non-GLP compliant) during the initial discovery such as Go/No-Go decision, drug bioavailability, safety pharmacology, and general toxicology.
PK Simulations
Using 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 to 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 validated version of Phoenix WinNonlin to perform PK and TK calculations and create SEND data transfer files.