Article | February 3, 2023

Mechanistic Vs Statistical Models: Using Mathematical Models To Improve Process Development

Source: Cytiva

Mathematical models are recommended by the ICH Q8(2) guidelines on pharmaceutical development to generate enhanced process understanding and meet Quality-by-Design (QbD) guidelines. Mathematical models can be built using two fundamentally different paradigms: statistics or mechanistically. Discover the differences between statistical and mechanistic models along with the benefits of each. Additionally, learn how these mathematical models can be used to improve process development, build a digital twin, and more.

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