Chapter 6: Justifying Multivariate Experimental Designs to Leadership

Overview.. 127

The Problems: Developmental Experiments Lack Structure. 128

Why Not One Factor at a Time?. 128

Data Visualization to Justify Multivariate Experiments. 135

Using the Dynamic Model Profiler to Estimate Process Performance. 140

Practical Conclusions. 143

Exercises. 143

 

Overview

Development of new products and processes is the life blood of a healthy organization. The pharmaceutical industry has gone through a revival since guidelines promoting Quality by Design (QbD) were published by the International Council on Harmonisation (ICH), a consortium of regulatory bodies from around the world. ICH E8 and ICH E9 guidelines were published to promote risk-based development ...

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