IN VITRO STATISTICAL SERVICES

Elevate Your Research with VitelyBio’s In Vitro Statistical Services

At VitelyBio, we specialize in providing comprehensive in vitro statistical services designed to support your research and development needs. Our services are tailored to ensure precision, reliability, and compliance with regulatory standards, making us the ideal partner for your scientific endeavors.

What Are In Vitro Statistical Services?

In vitro statistical services involve the application of statistical methods to analyze data obtained from laboratory experiments conducted outside of living organisms. These services are crucial for:

Dissolution Profile Comparisons:

In vitro statistical services involve the application of statistical methods to analyze data obtained from laboratory experiments conducted outside of living organisms. These services are crucial for:

Equilibrium and Kinetic Studies:

Analyzing the equilibrium and kinetic properties of various compounds.

Population Bioequivalence:

Assessing bioequivalence for different formulations based on specific guidelines.

In Vitro Release and Permeation Tests:

Conducting tests to evaluate the release and permeation characteristics of drugs.

Stability Data Analysis:

Conducting tests to evaluate the release and permeation characteristics of drugs.

We Offer Detailed Statistical Services for the following:

Model Independent Approach Using a Similarity Factor (f2):

This method helps in comparing dissolution profiles effectively.

Multivariate Statistical Distance (MSD):

A robust approach for dissolution profile comparisons.

In Vitro Equilibrium and Kinetic Studies

Essential for understanding the behavior of compounds under various conditions.

Bootstrap f2

An advanced statistical method for dissolution profile analysis.

Population Bioequivalence:

Conducted based on specific PSG requirements for various formulations:

  • 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):

Evaluates the release characteristics of drugs.

In Vitro Permeation Test (IVPT):

Assesses the permeation properties of drugs through biological membranes.

Cut-point and Sensitivity Analysis:

Critical for determining the sensitivity and specificity of assays.

Stability Data Analysis:

Performed in accordance with FDA guidance “Q1E Evaluation of Stability Data”.

Comparative Nasogastric (NG) Tube Studies:

Evaluates the compatibility of formulations with NG tubes.