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

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