BE & PK
Bioequivalence & Pharmacokinetic
Operated by Research Unit 08
Institutional Narrative & Focus
The Bioequivalence & Pharmacokinetics Unit supports pharmaceutical development through rigorous study design, bioanalytical quantification, and statistical evaluation of drug exposure. The unit designs and executes bioequivalence and pharmacokinetic protocols, from sample collection and processing through validated HPLC and LC-MS/MS assays. Core deliverables include Cmax, Tmax, AUC, half-life, and elimination-rate analysis, comparative bioavailability assessment, IVIVC, and biodistribution studies — including tissue accumulation and nanoparticle distribution. Preclinical PK programmes and formal bioequivalence statistics help partners generate regulatory-ready evidence of product performance and safety.
Scope of Services
Our specific testing configurations, validated chemical assays, and molecular panels:
- Bioequivalence Study Design & Protocol Development
- Pharmacokinetic (PK) Study Design
- Pharmacokinetic Sample Collection & Processing
- Bioanalytical Method Development
- Bioanalytical Method Validation
- Drug Quantification using HPLC/LC-MS/MS
- Pharmacokinetic Parameter Analysis
- Cmax, Tmax, AUC, t½, and Kel Analysis
- Comparative Bioavailability Assessment
- In Vitro–In Vivo Correlation (IVIVC)
- Biodistribution Study Design
- Tissue Distribution & Drug Accumulation Analysis
- Nanoparticle Biodistribution Studies
- Preclinical Pharmacokinetic Studies
- Statistical Analysis & Bioequivalence Evaluation
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