Bioequivalence Evidence You Can Submit With Confidence
IQA designs, executes, and analyzes BA/BE studies with the statistical rigor regulators expect — supporting generic approvals, formulation bridging, and product comparability claims.
Bioavailability and bioequivalence (BA/BE) studies sit at the center of generic drug approval, formulation changes, and product line extensions. A single misstep in design or analysis can mean a failed study, a regulatory deficiency letter, or a costly repeat — which is why rigor at every stage matters.
IQA's Clinical Pharmacology team combines study design expertise, validated NCA and statistical workflows, and deep familiarity with FDA and EMA bioequivalence guidance to deliver evidence that stands up to regulatory scrutiny the first time.
Study Design
- Design crossover, parallel, and replicate studies tailored to product pharmacokinetic profiles and regulatory pathways, including highly variable drug considerations.
Sample Size & Power Calculations
- Determine statistically defensible sample sizes that balance study costs against the risk of inconclusive bioequivalence results.
Noncompartmental Analysis (NCA)
- Derive Cmax, AUC, Tmax, and half-life using validated Phoenix WinNonlin workflows aligned with regulatory-standard methodologies.
Statistical Bioequivalence Assessment
- Perform 90% confidence interval analysis, average bioequivalence (ABE), and scaled average bioequivalence (SABE) for highly variable drugs using log-transformed analysis aligned with FDA and EMA expectations.
Regulatory Strategy & Submission Support
- Prepare study reports and statistical analysis plans to support ANDA, NDA, and other regulatory submissions.
Fasting & Fed Studies, Food-Effect Assessments
- Design and conduct fasting and fed studies to characterize the impact of meals on drug absorption and bioavailability.
How We Work
Study Design
Define the appropriate study design, target population, and sampling schedule based on your product and regulatory requirements.
Data Collection
Coordinate sample collection, bioanalytical data management, and concentration-time data flow.
NCA
Derive PK parameters including Cmax, AUC, Tmax, and half-life using validated Phoenix WinNonlin workflows.
Statistical Assessment
Perform confidence interval analysis and equivalence testing appropriate to your product variability profile.
Regulatory Package
Deliver submission-ready study reports, statistical analysis plans, and supporting documentation for regulatory submissions.
Regulatory-Grade Rigor
Every study design and statistical analysis is built to withstand FDA and EMA regulatory scrutiny, ensuring compliance from the outset rather than making adjustments after the fact.
Validated Infrastructure
Phoenix WinNonlin and supporting statistical tools are documented and validated (IQ/OQ/PQ or equivalent), ensuring accurate analyses and audit-ready submission packages.
Statistical Depth for Complex Cases
Expertise in highly variable drugs, narrow therapeutic index products, and replicate study designs beyond standard two-way crossover approaches.
Integrated Pharmacology Expertise
Backed by IQA’s broader Clinical & Quantitative Pharmacology team, BA/BE findings integrate seamlessly with population PK, IVIVC, and MIDD analyses to support your development program.
Frequently Asked Questions
Have a BA/BE study to design or analyze?
Talk to our team about your product's bioequivalence strategy — from first design conversation through submission-ready reporting.