F Welcome to Educe Global Inc.
 
 
     
        
Software Products
DissoXpress©
IvivcXpress©
PK-Xpress©
QbD-Xpert©
Consultancy
Article on QbD
 
 
 
 Products & Services
      
   
QbD-Xpert©  
   

The software to support your entire QbD steps during R&D stage considering Focus Areas, Risk Matrix, Scoring and predetermined in vitro or in vivo endpoints based on clinical considerations for design space.

 
Salient Features:
Process Block Diagram & Input/Output Diagrams
Material Attribute and Process Parameter Brainstorming with output stored as Ishikawa (Fishbone) Diagrams
Quality Target Product Profile (QTPP) creation templates
Critical Quality attributes for individual or groups of process steps with severity scoring
Formulation and Initial Process Risk Assessment Tool (Preliminary Hazard Analysis)
Process Risk Assessment tools (Cause & Effect matrix and FMEA) with Justifications
Optional Decision Confidence Scoring for Risk Assessments
Ability to link every decision taken in a risk assessment to the output
Multiple outputs from Risk Assessments including Pareto plots and Heat-map charts
Multiple Risk Assessments per step with automatic "What's changed" view
Design of Experiments (DOE) - two level factorial screening and response surface designs using Plackett-Burman & Central
   
 
Composite Design & D-optimal Models:
DOE output options include half normal plots, 2D contour and 3D surface plots
Prediction of plasma concentration time profile from in vitro dissolution to define the design space

 

  
 
HOME  |  ABOUT US  |  OUR TEAM   |  CONTACT US  | 
Copyright © 2012. All Rights Reserved. Developed by Technosys