Assay validation
Validated methods for parent drugs and relevant metabolites in the selected biological matrix.
← Bioanalysis ServicesGeneric & Hybrid Programs
Bioequivalence Studies
Analytical and pharmacokinetic support for bioequivalence programs, including validated assays, sample analysis, statistical evaluation, and study-ready reporting.
Validated AssaysPK Parameters90% CIRegulatory Reports
From concentration data to equivalence conclusions.
rebirthBiology links bioanalytical execution with PK/statistical interpretation so sponsors can evaluate test and reference products with confidence.
Clinical sample analysis
Batch analysis with calibration, QC review, repeat management, and sample accountability.
PK calculations
Cmax, Tmax, AUC, half-life, and other non-compartmental parameters as required.
Statistical evaluation
Geometric mean ratios, confidence intervals, and tabular outputs for BE interpretation.
Why Choose
BE programs need disciplined interfaces.
Bioanalysis + PK
Data flow is controlled from sample result through statistical table.
Regulatory format
Reports are structured for generic, hybrid, and comparative development dossiers.
Timeline focus
Repeat rules, run review, and deliverable milestones are aligned before samples arrive.
Design the analytical backbone for your BE study.
Send the protocol synopsis, analyte list, matrix, expected range, and reporting needs.
Discuss Bioequivalence