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Design of Experiments (DOE) Principles for Pharmaceutical Development

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This document discusses Quality by Design (QbD) principles and Design of Experiments (DOE) methodology. It explains that QbD aims to design quality into products and processes through an understanding of key factors and their interactions. DOE provides a systematic approach to determine these factors and optimize conditions through carefully designed experiments. Common DOE steps include screening experiments to identify important factors, followed by optimization experiments to determine optimal levels and robustness testing to ensure consistent performance under variations.

Health & MedicineTechnology
1 of 22
Design of Experiments (DOE) G.Gallo 11 marzo 2009
Concept of Quality by Design (QbD) ,[object Object],[object Object],[object Object],[object Object]
Process analytical technology ( PAT ) ,[object Object],[object Object],[object Object]
Different methods ,[object Object],[object Object],Changing a single factor a time doesn’t necessarily provide information about the optimum conditions in particular when there are interactions between factors. BUT
DOE ,[object Object],[object Object]
Where DOE is used? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The main questions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],DOE provides an organized approach where the experimenter is guided to perform a set of experiments, that are then evaluated in terms of a local regression model and interpreted to make decisions
Common steps in DOE
Screening ,[object Object],[object Object],[object Object],[object Object]
Definition of factors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Specification of responses ,[object Object],[object Object],[object Object]
N°Experiments X1 X2 X3 1 - - - 2 2 full factorial design 2 + - - replicate experiments 3 - + - 2 3 full factorial design 4 + + - 2 3-1 fractional factorial design 5 - - + 6 + - + 7 - + + 8 + + + 9 0 0 0 10 0 0 0 11 0 0 0
Example 1: Reduction of enamines to saturated amines by formic acid ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Example 1: (continued) ,[object Object],[object Object],[object Object]
Computation of effects - Least square analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Causes of poor models ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Optimization ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Response contour plot ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Robustness testing ,[object Object],[object Object],[object Object],[object Object]
Example 2: Quality documentation of a HPLC system ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Example 2: (continued) ,[object Object],[object Object],[object Object],[object Object]
Selection of the model and generation of design ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Bibliography ,[object Object],[object Object],[object Object],[object Object]

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Design of Experiments (DOE) Principles for Pharmaceutical Development

  • 1. Design of Experiments (DOE) G.Gallo 11 marzo 2009
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  • 11. N°Experiments X1 X2 X3 1 - - - 2 2 full factorial design 2 + - - replicate experiments 3 - + - 2 3 full factorial design 4 + + - 2 3-1 fractional factorial design 5 - - + 6 + - + 7 - + + 8 + + + 9 0 0 0 10 0 0 0 11 0 0 0
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