Stability-Related Dissolution for Oral Solid Drug Products: A Digital Tool Overview and Credibility Assessment (Copy)

• Course summary

  This course introduces an approach to simulate the impact of long-term storage on the dissolution performance of solid-oral drug products. You will learn how this digital predictive model can inform the risk of long-term stability-related dissolution change.

• Course outline

  The course contains the following sections:

  • Question of Interest

  • Context of Use

  • Model Overview

  • Model Risk Assessment

  • Three Different Ways to Model Dissolution

  • Modelling Decay

  • Modelling Temperature and Relative Humidity with a Modified Arrhenius Equation

  • Returning to the Dissolution Model

  • Recap

• Learning outcomes

  The main objectives of the course are to:

  • Understand three different approaches for modelling dissolution profiles (Weibull, Logistic, and Gompertz equations)

  • Understand how to model decay of these dissolution profiles using the acceleration factor model

  • Understand how to model the effects of temperature and relative humidity for these dissolution profiles

  • Give the learner sufficient domain knowledge to investigate the performance of this digital tool using the Digital CMC Sandbox developed by the Digital CMC CERSI

• Who will benefit

  Pharmaceutical professionals, regulatory affairs professionals, regulators and researchers who want to understand the concepts and methods underlying this digital predictive tool.

This course is delivered by CMAC’s Digital CMC CERSI team.

Available now

Format: E-learning

Free for all CMAC members

Approx 2 hours

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