Precise PK Parameters, Every Time
IQA delivers validated noncompartmental analysis — the foundation for bioequivalence assessment, dose justification, and regulatory submissions across every phase of development.
Our Approach
Noncompartmental analysis (NCA) is the starting point for nearly every pharmacokinetic evaluation — from first-in-human studies to bioequivalence assessments to population PK modeling inputs. Getting it right matters: parameter estimates derived here often feed directly into dosing decisions, regulatory submissions, and downstream modeling work.
IQA's Clinical Pharmacology team performs NCA using validated, industry-standard workflows in Phoenix WinNonlin, ensuring parameter estimates are accurate, reproducible, and audit-ready.
What We Offer
Standard PK Parameter Derivation
- Calculate Cmax, Tmax, AUC (0-t, 0-∞, 0-24h), half-life, clearance, and volume of distribution using regulatory-standard methodologies.
Single- and Multiple-Dose Analysis
- Perform NCA across single-dose, steady-state, and multiple-dose study designs to characterize pharmacokinetic profiles.
Sparse Sampling Support
- Estimate PK parameters from limited per-subject sampling, supporting pediatric, oncology, and other vulnerable population trials.
Data Handling & BLQ Management
- Apply defensible below-limit-of-quantification (BLQ) data handling strategies in accordance with accepted regulatory conventions.
Regulatory-Ready Reporting
- Generate clear, submission-ready tables, listings, and figures (TLFs) summarizing PK parameters for clinical study reports and regulatory submissions.
Integration With Downstream Analyses
- Connect NCA outputs directly with bioavailability/bioequivalence (BA/BE) assessments and population PK modeling to support integrated development programs.
Data Receipt - Collect and format
Concentration-time data are received, organized, and formatted for pharmacokinetic analysis.
QC & Cleaning - Verify data
Check data completeness, consistency, and quality, including appropriate handling of below-limit-of-quantification (BLQ) values.
NCA - Derive PK parameters
Calculate pharmacokinetic parameters using validated Phoenix WinNonlin workflows and regulatory-standard methodologies.
QC Review - Independently verify
Conduct an independent review of PK parameter outputs against source data to ensure accuracy and avoid single-reviewer dependency.
Reporting - Deliver final outputs
Generate submission-ready tables, listings, and figures to support clinical study reports and regulatory packages.
Scientific Depth, Practical Delivery
Our team combines academic rigor with CRO-speed delivery.
Regulatory Fluency
We build every analysis with submission-readiness in mind, aligned to FDA and EMA expectations from day one.
Validated, Audit-Ready Infrastructure
Our modeling environment (NONMEM, R) is documented and validated to regulatory standards, so your submission stands up to scrutiny.
A Partner, Not Just a Vendor
We integrate early - ideally at protocol design - so quantitative thinking shapes your program from the start, not just the data analysis at the end.
Frequently Asked Questions
Need PK parameters you can trust?
Talk to our team about your study's NCA needs — from single studies to ongoing program support.