Statistical methods in evaluation and monitoring of product stability

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.

Who should attend?

• 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 learn?

• 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

Training programme:

1. Introduction
   • What are the basic regulations governing stability testing
   • What factors influence the stability of a medicinal product
   • Which product parameters should be subject to stability studies
   • What are the types of stability studies
   • What are the principles for applying clustering/matrixing in stability studies
   • What are the advantages and disadvantages of clustering / matrixing in stability studies
   • When statistical analysis of stability data is required
   • Which parameters are subject to statistical evaluation
   • How to justify deviation from statistical evaluation
   • Which statistical methods to use in determining the shelflife
   • What are the basic regulations for a ongoing stability study programme
   • What is an atypical trend in continuous stability studies
2. Evaluation of stability studies acc. to ICH Q1E
   • How to choose a statistical model
   • How to verify if a model is statistically significant
   • How to verify if the chosen model is adequate
   • What if the selected model is incorrect
   • How to determine the shelflife / retest period based on the selected model
   • What is the difference between a confidence interval and a prediction interval
   • How to determine the probability of an OOS result
   • What are the rules for evaluating stability studies for multiple batches
   • When can data from multiple batches be combined to estimate a shelflife
   • What is the procedure for analysis of covariance for multiple series
   • What are the stability models resulting from the analysis of covariance for multiple series
   • How to choose an appropriate stability model based on the analysis of covariance
3. Ongoing stability study programme acc. to Ch.6 GMP
   • What is a statistically significant trend
   • What are the types of atypical trends in stability studies
   • What is the difference between OOS/OOT/OOE results in stability studies
   • What if an atypical trend in stability studies occurs
   • What methods should be used to assess atypical trends in stability studies

Training hours: 8:15 AM – 3:30 PM

The training includes:

• comprehensive training materials
• certificate of completion
• coffee breaks and lunch (for on-site training)

Training types:

• online or on-site
• the format is indicated with the training date

For online trainings:

• live sessions via MS Teams
• real-time interaction with the instructor

Prerequisites:

• computer skills in a Windows environment

Price: 620 EUR net

Price for academic Statistica users with an active StatSoft Polska support agreement (-15%)*: 527 EUR net