DESIGN OF EXPERIMENTS (DOE) IN PHARMACEUTICS: A COMPREHENSIVE REVIEW

Planning experiments in a methodical way helps scientists create and enhance drug formulas and production techniques in a scientific way. By studying different factors together, DOE can identify important materials, processes, and qualities that affect how well a drug works. DOE makes things more efficient by cutting down on the number of experiments needed and by finding hidden relationships between different factors, which is better than older, less efficient methods. This review covers key DOE techniques such as factorial designs, Response Surface Methodology (RSM), mixture designs, and optimal designs, which are used in different types of drug delivery systems like oral, transdermal, and injectable forms. It also looks into Quality by Design (QbD) from a regulatory perspective, including how Bayesian and adaptive designs, alongside machine learning, are used. The article concludes by pointing out successful methods and current trends in making reliable, affordable, and legally approved medicines.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-10-16
DOI
https://doi.org/10.5281/zenodo.17368649
Primary Topic
Statistical Methods in Clinical Trials
Type
article
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article

DESIGN OF EXPERIMENTS (DOE) IN PHARMACEUTICS: A COMPREHENSIVE REVIEW

Zenodo (CERN European Organization for Nuclear Research)
Statistical Methods in Clinical Trials
article

DESIGN OF EXPERIMENTS (DOE) IN PHARMACEUTICS: A COMPREHENSIVE REVIEW

article en

Abstract

Planning experiments in a methodical way helps scientists create and enhance drug formulas and production techniques in a scientific way. By studying different factors together, DOE can identify important materials, processes, and qualities that affect how well a drug works. DOE makes things more efficient by cutting down on the number of experiments needed and by finding hidden relationships between different factors, which is better than older, less efficient methods. This review covers key DOE techniques such as factorial designs, Response Surface Methodology (RSM), mixture designs, and optimal designs, which are used in different types of drug delivery systems like oral, transdermal, and injectable forms. It also looks into Quality by Design (QbD) from a regulatory perspective, including how Bayesian and adaptive designs, alongside machine learning, are used. The article concludes by pointing out successful methods and current trends in making reliable, affordable, and legally approved medicines.

Zenodo (CERN European Organization for Nuclear Research)
National Archives and Records Administration (US)
Openalex Percentile: Top 38%
Statistical Methods in Clinical Trials
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