Design & Analysis of Shelf-Life & Stability Studies

Design & Analysis of Shelf-Life & Stability Studies

Shelf-life data possess specific features so that their design and analysis require adapted statistical tools. Key elements in the study design are presented and survival techniques used to analyze life data are covered and illustrated.

Course Details

Learning Objectives

Learning Objectives:

Upon completion of this module, participants will have learned:

  • The tools available to define shelf-life in a specific context
  • The specific features of life data
  • The notion of competing risks and its impact on the results
  • What statistical analysis techniques adapted to life data are available
  • The modeling techniques especially designed for life data
  • How to interpret results and what the scope of the results are

Target Audience

Target Audience:

This module is intended for people who want to improve the way to design and analyze shelf-life and stability studies with the increased knowledge of the most recent tools in this field. It is also intended for people who need to evaluate the scope and validity of existing shelf-life and stability studies. Finally, people who want to compare their current practices with the regulatory requirements and recommendations will find the course very useful.

Prerequisite

Prerequisite:

This module introduces the important ideas in statistics and data analysis applied to the field of shelf-life and stability studies. It assumes that participants have no previous knowledge of statistics or that they have not used it for a long time.

Course Outline

Course Outline:
  • Introduction
  • Difference between Shelf-Life & Stability Studies
  • Introduction to Life Data
  • Defining the Event of Interest that Causes the Failure of the Product
  • Specific Features of Life Data and Impact on Statistical Analysis
  • Typical Layout of Results
  • Designing Efficient Studies
    • Impact of End of Study Time, Censoring, Competing Risks, Destructive & Non-destructive Testing, Sample Variability
    • Experimental Design:  Sample Selection, Sample Size & Statistical Power, Dynamic Designs
    • Analysis of Stability Studies
      • Analyzing Time to Event Data to Estimate Shelf-Life
      • Reasons Why Usual Analysis Methods Fail
      • Kaplan-Meier Non-Parametric Survival Curve Estimation
      • Parametric Survival Curve Estimation
      • Overview of Semi-Parametric Survival Curve Estimation
      • Why Accelerated Shelf-Life Testing (ASLT) Models?
      • Software

Practical Info

Practical Info:

Recommended Duration: 1 to 1.5 day

Course Materials:

  • Course notes on statistical techniques
  • Sample datasets
  • Course Reviews

    • posted by Jadwiga Mazur

      The course is excellent and Natalie is a top-notch teacher/trainer who presents all underlying statistical theories in a simple and easy to follow way. I learned a lot in a relatively short time and would recommend this course to everyone interested in this topic.

    • posted by Aneta Krzywak:

      The course was excellent and well presented. The information presented has helped me re-evaluate goals associated with the shelf life & stability studies carried out. Thanks Natalie!

    • posted by Line-Roy Arcand

      I have attended the one-day "Efficient Design and Analysis of Shelf-Life and Stability Studies" training session last fall. The course is well designed. It goes straight to the major topics and the trainer did a very good job answering our questions. I have no hesitation to recommend it!! Line Roy-Arcand, senior research manager, Premier Tech Biotechnologies.

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