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

Online training course
Written By Steven Scott

  • 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.

  • 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

  • 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

  • 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

Register your interest:

Steven Scott

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