Abstract
The pharmaceutical drug products and process optimization with the help of traditional approaches are not new and for decades it has been performed with the help of one variable at a time (OVAT) approach. Although such shotgun approach has yielded the requirement and served the purpose to provide optimized solutions, yet achieving the true optimum is not guaranteed. Moreover, traditional approaches require extensive utilization of time, energy, and efforts to plug the errors and to rectify the problem. The approach of systematic optimization using design of experiments (DoE) principles is considered as highly satisfactory for providing the best solutions by establishing the relationship between the factors and responses. Such approach has yielded satisfactory outcomes with respect to its applicability for diverse pharmaceutical product and process optimization. The present chapter endeavors to provide an account on the basic principles and fundamentals of experimental design and their applications in drug product development.
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Beg, S., Swain, S. (2021). Introduction to the Experimental Designs: Basic Fundamentals. In: Beg, S. (eds) Design of Experiments for Pharmaceutical Product Development. Springer, Singapore. https://doi.org/10.1007/978-981-33-4717-5_1
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DOI: https://doi.org/10.1007/978-981-33-4717-5_1
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