Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

BA/BE Study Monitoring & PK Analysis

Auriga provides independent CRO monitoring of bioequivalence studies and PK analysis using Phoenix WinNonLin. We do not conduct BE studies. Sponsors engage Auriga to add an independent layer of CRO oversight on BE studies executed at partner clinical pharmacology units and bioanalytical labs.

Our scope covers protocol and SAP review, on-site monitoring of dosing and PK sample collection, bioanalytical method validation review, study sample analysis oversight, independent non-compartmental and compartmental PK analysis, bioequivalence statistics, and submission-ready reporting to CDSCO, FDA, and EMA standards.

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What's Included

Clinical Monitoring

✓ Protocol review and SAP input
✓ Site qualification and selection review
✓ On-site dosing & PK sample-collection monitoring
✓ 21 CFR Part 11 source data verification

Bioanalytical Oversight

✓ Method validation review (FDA 2018 / EMA / ICH M10)
✓ Study sample analysis monitoring
✓ ISR (incurred sample reanalysis) verification
✓ Audit trail and data integrity review

PK Analysis

✓ Phoenix WinNonLin — non-compartmental & compartmental
✓ Cmax, Tmax, AUC₀–t, AUC₀–∞, t½, Ke
✓ 90% CI on ratio of Cmax and AUC
✓ Independent dataset reconciliation

Reporting

✓ Independent monitoring report
✓ PK analysis report (CDSCO / FDA / EMA format)
✓ CDISC-aligned PK datasets
✓ Submission support for ANDA / NDA

FAQs

Does Auriga conduct bioequivalence (BE) studies?

No. Auriga Research does not conduct BE studies. We provide independent CRO monitoring of bioequivalence studies and pharmacokinetic analysis using Phoenix WinNonLin. Sponsors engage Auriga for protocol review, on-site monitoring of the clinical and bioanalytical phases at partner BE units, and independent PK analysis and reporting.

What does Auriga do as an independent BE monitor?

As an independent CRO monitor, Auriga reviews the BE study protocol and statistical analysis plan, conducts on-site monitoring at the clinical pharmacology unit during dosing and PK sample collection, verifies bioanalytical method validation and study sample analysis at the partner bioanalytical lab, and performs independent PK analysis using Phoenix WinNonLin. We report findings and observations directly to the sponsor.

What software does Auriga use for PK analysis?

Phoenix WinNonLin — the regulatory-standard non-compartmental and compartmental PK analysis software. We deliver fully validated PK datasets, computation of standard parameters (Cmax, Tmax, AUC, t½, Ke), bioequivalence statistics (90% confidence intervals on ratio of Cmax and AUC), and audit-traceable reports suitable for CDSCO, FDA, and EMA submissions.

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