Chapter 17: Exploring Stability Studies with JMP

Overview.. 397

The Problem: Transdermal Patch Stability. 397

Summarizing Stability Data. 398

Adding Initial Results and Formatting for Stability Studies. 401

Running Stability Analysis. 406

Stability—Linear Model Diagnostics. 412

Using Stability Estimates to Calculate Internal Limits. 414

Practical Conclusions. 417

Exercises. 417

Overview

Pharmaceutical products have rigorous requirements. The product must resist environmental exposure so that all critical quality attributes (CQAs) meet specifications through the expiration date. Maintaining a stabile formulation can be one of the most challenging aspects of drug development since many drug substances are sensitive to exposure to light, temperature, ...

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