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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.



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 Michelle Stranges

      This was an excellent course and very relevant for an upcoming study. Natalie presented information in a clear, logical format that made it easy to understand

    • posted by Susan Kwan

      This course was excellent knowledge for any one trying to decipher and analyze the intricate experimental design necessary to develop and perform shelf-life. Natalie is an excellent instructor. She presented the information in a clear, concise way .

    • posted by Karen Gillis

      This course provided the insight that we needed to further develop our teams ability to design stability, and shelf life studies. Natalie's ability to adapt to our groups understanding was superb, her intuition kept the pace of the seminar going as well delivering information to keep all of our attention. Job well done! and Thank you

    • posted by Esther Lee

      An excellent overview of shelf-life and stability tests. Some contents discussed during the course made us think of different perspectives when designing for shelf-life determination. Michel and Natalie make a great team of instructors!

    • posted by Edward Oamen

      This course provided the insight that I would apply in the design of my future scientific researches and in the performance of the necessary stability studies. Ms. Natalie Rodrigue was an excellent instructor. She was very comfortable teaching the course and easy to listen to. She responded to the questions with good examples.

    • posted by Krish Ganesan

      This course provided the basic framework for doing stability testing & statistical principles behind the testing. After this course, I am more interested in learning further.

    • posted by Sylvia De Long

      This was an excellent easy to understand course. The instructor did a great job of explaining the material in a way that was helpful and direct. If you don't have an indepth statistics background - don't worry - you won't have any trouble understanding the material. I would recommend this class to anyone that is trying to put together a shelf-life or stability program in their company or for research.

    • posted by Ami Henriques

      This course provides and easy to understand overview of shelf-life and stability testing, specifically focusing on test design and analysis. The instructor, Natalie, presented the information clearly and focused any discussions on specific applications within each of the participants respective companies.

    • posted by Anna marin

      The most valuable point emphasized in this workshop was the need to establish a valid, measurable criterion for product stabitly so that the statistical tools and choice of tools can be used effectively and successfully. This key to successful shelf life testing was very well presented.

    • posted by Sanja Ilic

      The course was excellent and well presented. It provided me with the basic knowledge necessary to set up a sound shelf life study. With my limited stats background, I was still able to follow and participate. Sharing experience with other participants was very valuable. Thanks Natalie!

    Related Sessions

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