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Understanding Design of Experiments (DOE)

Design of Experiments (DOE) is a systematic method used to study the relationships between multiple input and output variables, playing a crucial role in quality by design (QbD) for pharmaceutical manufacturing. It provides a statistical framework for validating processes, identifying key factors, and analyzing interactions, while factorial designs offer advantages such as efficiency and the ability to evaluate multiple factors simultaneously. However, challenges include increased complexity and difficulty in interpretation as the number of factors grows.

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95 views10 pages

Understanding Design of Experiments (DOE)

Design of Experiments (DOE) is a systematic method used to study the relationships between multiple input and output variables, playing a crucial role in quality by design (QbD) for pharmaceutical manufacturing. It provides a statistical framework for validating processes, identifying key factors, and analyzing interactions, while factorial designs offer advantages such as efficiency and the ability to evaluate multiple factors simultaneously. However, challenges include increased complexity and difficulty in interpretation as the number of factors grows.

Uploaded by

justinsanjay11
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Design of experiments (DOE) is a systematic, efficient method that enables scientist to study the

relationship between multiple input variables (factors) and output variables (responses).

(DOE) is a statistical and mathematical tool to perform the experiments in a systematic way and
analyze the data efficiently.

The development of a design space involves full understanding of the statistical relationships
between the input variables (e.g. raw material and active pharmaceutical ingredient attributes),
manufacturing process parameters, and output response variables represented by finished drug
product.

Among various mathematical modeling approaches, Design of Experiments (DoE) is extensively


used for the implementation of QbD in both research and industrial settings. In QbD, product and
process understanding is the key enabler of assuring quality in the final product.

Used as one of the statistical tools for validation, design of experiments can help identify which
factors need to be controlled in order for a system or product to pass the ruggedness test. Design of
experiments (DOE) has become an essential tool for the validation of medical manufacturing
processes.
•
Factors
Factors may be qualitative and quantitative. Qualitative relates to alphabetical value
or quantitative relates to numerical value.
Levels
(i) Low
(ii) Intermediate
(iii) High

Simultaneously coding takes place for levels


(i) Low = (-)
(ii) Intermediate = (0)
(iii) High = (+1)
•
•
•

Runs Factors Interaction


A B AB
1 -1 -1 +1
2 +1 -1 -1
3 -1 +1 -1
4 +1 +1 +1

Treatment Replicate Total


Combination
I II III
A Low, B Low 19 18 21 58
A High, B Low 23 25 22 70
A Low, B High 26 23 21 70
A High, B High 31 37 32 100
•

Runs Factors Interaction


A B C AB AC BC ABC
1 -1 -1 -1 +1 +1 +1 -1
2 +1 -1 -1 -1 -1 +1 +1
3 -1 +1 -1 -1 +1 -1 +1
4 +1 +1 -1 +1 -1 -1 -1
5 -1 -1 +1 +1 -1 -1 +1
6 +1 -1 +1 -1 +1 -1 -1
7 -1 +1 +1 -1 -1 +1 -1
8 +1 +1 +1 +1 +1 +1 +1
•
Advantages of Factorial Design
It is easier to study the combined effect of two or more factors simultaneously
and analyze their interrelationship.
It has wide range of factors combination are used.
It saves time.
It permits the evaluation of interaction effects.
Factorial design allow the effects of a factor to be estimated at several levels of
other factors.
The factorial design simplifying the process and making research cheaper,
allows many levels of analysis. As well as highlighting the relationships
between variables.
Factorial designs are more efficient than other experiments. They provide
more information at similar or lower cost.
Disadvantages of Factorial Design

Size of experiments will increase if the number of factors increases.

When a large number of treatment combinations are included in an


experiment, its execution as well as statistical analysis may become difficult.

Difficult to interpret the large size of the factorial experiment especially


when the interaction between factors are exit.

Increase in factor size leads to increase in block size which increases the
chances of error or loss precision.

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