IN VITRO
STATISTICAL SERVICES

The following Statistical Services are provided for

In Vitro dissolution profile comparisons

Model Independent Approach Using a Similarity Factor (The similarity factor f2)
Model Independent Multivariate Confidence Region Procedure using Multivariate Statistical Distance (MSD)
Bootstrap f2

In Vitro Equilibrium and Kinetic studies

Population Bioequivalence based on below PSG requirements:

Budesonide Suspension/Inhalation (for molecules : Doxorubicin, Enoxaparin, Triamcinolone, Loteprednol, Budesonide, Formoterol, Arformoterol, Ipratropium)
Albuterol sulfate Aerosol, metered; inhalation using 5 types of In Vitro studies (Single actuation content (SAC), Aerodynamic particle size distribution (APSD), Spray pattern, Plume geometry, Priming and repriming)
Fluticasone propionate Metered, spray; Nasal using 6 types of In Vitro studies (Single Actuation Content (SAC), Droplet Size Distribution by Laser Diffraction, Drug in Small Particles/Droplets, Spray Pattern, Plume Geometry, Priming and Repriming) (for molecules : Azelastine)
Cyclosporine Emulsion; ophthalmic using suggested approach the Earth Mover’s Distance (EMD) method
  • In Vitro Release Test (IVRT)
  • In Vitro Permeation Test (IVPT)
  • Cut-point and Sensitivity Analysis
  • Stability Data analysis based on FDA guidance “Q1E Evaluation of Stability Data”
  • In Vitro Comparative Nasogastric (NG) tube or feeding tube studies