Quality means fitness for intended use. Pharmaceutical quality refers to product free of contamination and reproducibly delivers the therapeutic benefit promised in the label to the consumer. The Quality of the pharmaceutical product can be evaluated by in vivo or in vitro performance tests. Quality by design assures in vitro product performance and In vitro product performance provides assurance of in vivo product performance. “Hence Quality by design relate to Product Performance”.
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Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications
Author-Mr. UMESH PATIL. Pursuing Master of Pharmacy (PHARMACEUTICS), KLE Society’s College of Pharmacy, Hubli. Karnataka.