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Title : Role of statistics in quality by design product development for pharmaceutical industry: a review
Authors : S. A. Kale, Dr. V. H. Bajaj
Abstract : Pharmaceutical industry is showing a positive approach towards Quality by Design (QbD) for discovery, development, and commercial manufacturing of biopharmaceutical products. Regulatory agencies are providing various guidelines for pharmaceutical industry to build quality, safety and efficacy into their new biopharmaceutical products. Such concept became known as Quality by Design. To assess the Quality by Design (QbD) product development till robust quality manufacturing, several statistical tools may used. This paper outlines the role of statistics in monitoring, evaluation, optimization and improvement of Quality by Design Product Development for Pharmaceutical Industry.

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