Design of Experiments in Pharmaceutical Development
- Авторы: Dhoot A.1, Fernandes G.1, Naha A.1, Rathnanand M.1, Kumar L.1
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Учреждения:
- Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
- Выпуск: Том 53, № 8 (2019)
- Страницы: 730-735
- Раздел: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/245968
- DOI: https://doi.org/10.1007/s11094-019-02070-4
- ID: 245968
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Аннотация
In order to develop high-quality pharmaceutical products, a traditional approach based the univariate or trial and error method was used in the past that led to several problems like non-reproducible, high-cost, and time consuming methods. To overcome these drawbacks, a new concept of the Design of Experiment (DoE) was introduced. DoE is a statistical element of the Quality by Design (QbD) approach introduced by British statistician Sir Ronald Fisher in 1925. The basic objectives of DoE are screening, optimization, and robustness. It involves the execution of experimental design on the basis of suitable variables along with statistical evaluation of obtained responses and exploration of the design space using mathematical or graphical approach. The statistical evaluation empowers to build up the quality of finished products and helps to meet the increasing demands for product of superior quality and standards. This article mainly focuses on the applications of DoE in pharmaceutical product development along with its objectives, design, and selection criteria.
Об авторах
Abhishek Dhoot
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Email: lk.kundlas@gmail.com
Индия, Madhav Nagar 576104, Manipal, Udupi, Karnataka
Gasper Fernandes
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Email: lk.kundlas@gmail.com
Индия, Madhav Nagar 576104, Manipal, Udupi, Karnataka
Anup Naha
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Email: lk.kundlas@gmail.com
Индия, Madhav Nagar 576104, Manipal, Udupi, Karnataka
Mahalaxmi Rathnanand
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Email: lk.kundlas@gmail.com
Индия, Madhav Nagar 576104, Manipal, Udupi, Karnataka
Lalit Kumar
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education
Автор, ответственный за переписку.
Email: lk.kundlas@gmail.com
Индия, Madhav Nagar 576104, Manipal, Udupi, Karnataka