Analysis of Stability Data
Short course
In Bedford
Description
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Type
Short course
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Location
Bedford
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Duration
1 Day
This course is designed to provide a thorough understanding of the statistical and graphical methods most commonly used for the analysis of data from stability studies and the estimation of shelf life (or retest period) for pharmaceutical and other products.
Facilities
Location
Start date
Start date
Reviews
Course programme
Practical exercises will make use of STATISTICA and each participant will receive a free one-month evaluation copy of the software if required. No previous knowledge of the statistical methods is assumed.
* Overview of statistical requirements in ICH guidelines
* Introduction to Linear Regression
* Using linearising transformations
* Estimation of shelf life using confidence/prediction limits
* Single Factor, Multi-Batch Studies
* Introduction to General Linear Models
* Testing for Poolability of batches
* Introduction to Multi-factor Studies (Bracketing & Matrixing Designs)
This one-day course can be delivered on-site for groups of participants and a two-day version can be arranged to include more advanced topics and/or analysis examples using your own study data.
Analysis of Stability Data