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Quality by Design in Formulation Development

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Introduction to Quality by Design (QbD)

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Abstract

Formulation development moved to Quality-by-Design in recent years under the aegis of the FDA. Quality-by-Design allow manufacturers to build the quality into the process instead of simply testing the final product and it also allow to manage small changes of the final formulation or dosage form without a complete redesign of the production line.

Quality-by-Design require the planning of experiments using Design-of-experiments in order to calculate the contribution of each factors and their interactions for the final products and what happened inside the space described by those experiments so that the outcome of every single variations will be known before doing the experiment itself. Besides Design-of-Experiments allows to include statistics inside the experiments rather than at end.

Quality-by-Design require planning, rigorous testing and, if possible, prior knowledge of the subject to better guide the process. All those procedures need to be thoroughly documented and subjected to continuous improvement and discussion.

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Authors and Affiliations

  1. Department of Pharmacy, National University of Singapore, Singapore, Singapore

    Camillo Benetti & Ayca Altay Benetti

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  1. Camillo Benetti
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  2. Ayca Altay Benetti
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Correspondence to Camillo Benetti .

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Editors and Affiliations

  1. Department of Pharmaceutical Sciences, Dr. H. S. Gour University, Sagar, Madhya Pradesh, India

    N. K. Jain

  2. University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, Punjab, India

    Neha Bajwa

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© 2024 The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.

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Benetti, C., Benetti, A.A. (2024). Quality by Design in Formulation Development. In: Jain, N.K., Bajwa, N. (eds) Introduction to Quality by Design (QbD). Springer, Singapore. https://doi.org/10.1007/978-981-99-8034-5_6

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