Stability Analysis

A key component of pharmaceutical product development is to determine product stability and shelf life. The basic statistical assumptions, tests and life predictions methods will be presented with examples. Determination of whether to pool data, use a common slope or fit the data individually will be presented. Sample size selection and stability estimation in compliance with FDA guidance is discussed.

Course Objectives

1. Design and analyze stability studies.
2. Determine the appropriate fitting method for any stability data set.
3. Determine shelf life.
4. Select appropriate analysis technique based on type of data.
5. Use and interpret the stability script and associated report.

Attendees

This course is required for all scientists, engineers and quality professionals who actively work on all aspects of discovery, product and process development where the goal is to characterize, optimize and improve product and process performance.

Prerequisites

There is no prerequisite for this course.

Section 1: Stability Definition and Introduction

FDA guidelines

Section 2: Stability Study Design

Sample size
Test conditions

Section 3: Stability Data Analysis and Life Prediction

Extendibility and Confidence Intervals
Shelf Life Determination
All batches pooled
All batches with individual fits
Common slope
Common Intercept

Section 4: Stress Testing