PL
EN
The aim of the course is to familiarise participants with the guidelines for stability studies with particular emphasis on the application of statistical methods of data analysis used in formal stability studies according to ICH Q1E and to identify atypical trends during an ongoing stability programme. The course combines a knowledge of specific pharmaceutical industry issues with an understanding of data analysis methods. Statistical methods will be initially discussed theoretically and then developed through exercises. After the course, participants will be able to propose appropriate techniques for visualisation and statistical evaluation of data in stability studies.
For whom?
For anyone involved in conducting and evaluating formal stability studies for registration dossier submission as well as evaluating stability data during an ongoing stability programme to identify atypical trends. You are welcome if you still know nothing about data analysis and statistics used in product stability evaluation. If you already know something, but need to brush up on your knowledge and move on to practice. Or if you are already familiar with statistics, but need a tool with which you can perform your analyses quickly and easily. This course is a foundation on which you can further build your data analysis knowledge and skills.
What will you gain?
- You will learn or systematise the basic concepts of statistical data analysis
- You will go through the steps of statistical evaluation of stability data
- You will become familiar with numerical and graphical methods of data analysis
- You will learn about selected issues of assessing product stability and identifying atypical trends
- You will get practical tips on how to avoid errors in data analysis and its interpretation
- You will gain a basis for the development of analytical skills
