SAS Institute Japan Corporation JMP Japan Division System Engineer Masahiro Makawa
In the formulation development guidelines (ICH - Q 8), the use of the experimental design method is mentioned as a method for practicing QbD (Quality by Design).In JMP, the experimental design method (including multivariate model fitting and design space construction) according to the contents of the guideline can be carried out by routine operation method, but in the process of analysis, features of data are summarized and graphed It is very important to grasp by grasping and to examine the analysis results in detail.
Recently I came across data that can realize these importance. This is the experimental data collected for formulation design of OD tablets at FG (Focus Group) for Pharmaceutical Prescription / Process Optimization Study of the Japan Pharmaceutical Society. The experiment was conducted based on the plan prepared by the experimental design method, and the data can be used for the following purposes.
- Screening factors that affect the quality characteristics of OD tablets, "collapse time".
- Using the screened factors, we apply the response surface model to three quality characteristics "Fast disintegration time (better)", "Hardness (better if higher)" and "Friability degree (better lower)", simultaneously Optimize.
Fortunately, I got permission to use this data from FG in this announcement.Therefore, by analyzing this data using JMP, we will explain the importance of "Determine data characteristics" and "Detailed consideration of report" described above.
