Level: Beginner
One of the areas emphasized when developing drugs using QbD (Quality by Design) is “Product & Process Understanding.” In particular, “Process Understanding” is a critical quality attribute (Critical Quality Attribute). This means securing the relationship between CQA) and process variables (Process Parameter, PP) as knowledge in the form of Y=f(X's), and this must be secured scientifically and logically through experimental data.
In this presentation, we will cover how to effectively and efficiently analyze data and draw conclusions using JMP to secure knowledge about the process. The detailed topics are as follows.
(1) Utilization of statistical hypothesis testing to confirm key process variables (CPP)
(2) Application of DOE for process characterization
(3) Utilization of DSD (Definitive Screening Design) for rapid process development
