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Shelf-Life & Stability Studies – Design & Analysis

Shelf-Life & Stability Studies – Design & Analysis

In this course, a variety of case studies will be used to present the most important aspects to consider for a sound determination of product shelf-life or stability. Starting from the assessment of the differences between shelf-life and stability studies, participants will learn for each type of study how to design efficient experiments to accurately determine the failure time of products. The issues discussed include the timepoint selection, how to handle destructive testing, the experiment size and the choice of samples.

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 analyse life data are covered and illustrated. The principle of accelerated shelf-life testing (ASLT) along with the conditions for a successful use will be discussed.

 

  • 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 Design
  •  Analysis of Stability Studies
    • Analysing 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
This module is intended for people who want to improve the way to design and analyse 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.
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

Recommended Duration: 1 day(s)

Course Materials:

TBD

Case Studies:

N/A

This Session Has 13 Reviews

  1. 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

  2. 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 .

  3. 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

  4. 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!

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. The most valuable point emphasized in this workshop was the need to establish a valid, measurable criterion for product stability 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.

  10. 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!

  11. 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.

  12. 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!

  13. 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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