Bioavailability and Bioequivalence (BA/BE)

We run BA/BE studies that generic manufacturers need to show their formulations perform the same way as reference products in humans.

Overview

BA/BE studies are the backbone of generic drug approval. You dose healthy volunteers with test and reference products, collect blood samples at scheduled timepoints, measure drug concentrations in plasma, and calculate whether the two formulations are bioequivalent. We handle the entire process from protocol writing to final study report.

What We Do

Single-dose and steady-state crossover designs with appropriate washout periods

Food-effect studies comparing pharmacokinetics under fed and fasting conditions

Calculating AUC, Cmax, and Tmax from concentration-time data

Statistical analysis using 90% confidence intervals for bioequivalence assessment

Preparing study reports formatted for ANDA submissions to regulatory agencies

Why Work With Us

We are 80 Bedded facility with Four LCMS with 21 CFR 11 compliance

Our clinical facility is equipped for overnight confinement and controlled meal administration

In-house bioanalytical lab means faster turnaround on sample analysis

Related Services

Bioanalytical

Drug concentration analysis using LC-MS/MS

Clinical Development Services

Phase I-IV trial management

Regulatory Services

CDSCO, USFDA, and global submissions

Bio Statistical Services

Study design and statistical analysis

Ready to Get Started?

Let's discuss how we can support your bioavailability and bioequivalence (ba/be) needs.