Scientific Standards
ValidationFrameworks
Six validation frameworks underpin every PRU study.
Bioanalytical
LC-MS/MS Method Validation
Selectivity, sensitivity, matrix effects, recovery, precision, accuracy, stability, and dilution integrity per FDA/EMA/ICH M10.
Analytical
HPLC Analytical Validation
Specificity, linearity, range, accuracy, precision, LOD, LOQ, and robustness per ICH Q2(R1).
Microbiological
Microbiological Assay Validation
Antimicrobial potency testing per Ph.Eur., USP, and WHO methods with full precision and accuracy profiling.
Stability
Stability Testing Protocols
ICH Q1A–Q1F long-term, intermediate, and accelerated stability studies with photostability and stress testing.
In-Vitro
Dissolution Method Development
USP Apparatus I/II/IV, BCS-based dissolution correlation, and biorelevant media method development.
Pharmacokinetic
PK Analysis & Modeling
Non-compartmental and compartmental PK analysis, WinNonlin/Phoenix, and population PK modeling.