Chapter 16: Using Statistics to Support Analytical Method Development
The Problem: A Robust Test Method Must Be Developed
Design Creation Using the Definitive Screening Design (DSD)
Making Estimates from the Model
Using Simulations to Estimate Practical Results
Overview
The United States Pharmacopeia (USP) has issued guidance regarding the use of statistics in support of analytical methods as one more leg of the Quality by Design (QbD) initiative. The proposed new General USP Chapter <1220> and the Analytical Procedure Lifecycle notes the goal to identify an analytical target profile (ATP). The ATP is being ...
Get Pharmaceutical Quality by Design Using JMP now with the O’Reilly learning platform.
O’Reilly members experience books, live events, courses curated by job role, and more from O’Reilly and nearly 200 top publishers.
