Analytical methods are required to be developed at different stages of the pharmaceutical product life cycle. These activities if properly not streamlined based on the knowledge of science and process understanding may lead to a very costly and time consuming procedure. Pharmaceutical industries are striving for new pol which can be added or replace the existing elements of quality and risk management system. expert Joseph M. Juran first outlined the concept of Quality by Design. (QbD).
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Mahapatra et al. (2020) studied this question.
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