SAS Institute Japan, Inc. JMP Japan Division Systems Engineer Naohiro Masukawa
The pharmaceutical development guideline (ICH-Q8) lists the use of experimental design as a method for implementing QbD (Quality by Design). In JMP, experimental design in accordance with the guideline (including fitting of multivariate models and construction of design space) can be performed using standard operations, but in the analysis process, it is very important to understand the characteristics of the data by summarizing and graphing them and to consider the analysis results in detail.
Recently, I came across some data that made me realize the importance of these factors. This data was collected from experiments conducted by the Pharmaceutical Sciences Society of Japan's Focus Group on Pharmaceutical Formulation and Process Optimization for the design of an OD tablet formulation. The experiments were conducted based on a plan created using experimental design, and the data can be used for the following purposes:
- Screening factors that affect "disintegration time," a quality characteristic of OD tablets.
- Using the screened factors, a response surface model is fitted to three quality attributes: disintegration time (faster is better), hardness (higher is better), and friability (lower is better), and these are optimized simultaneously.
Fortunately, FG gave me permission to use this data in this presentation. I will analyze the data using JMP and explain the importance of "understanding the characteristics of the data" and "detailed consideration of the report" mentioned above.
