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The book explores the application of ICH guidelines in pharmaceuticals, emphasizing Quality by Design (QbD) principles for ensuring product efficacy, quality, and safety. It details a spectroscopic method for analyzing netilmicin, showcasing a simple and cost-effective approach through UV spectroscopy. The study incorporates derivatization techniques and compares the accuracy and precision of the proposed methods against standard UV reference methods. An Ishikawa diagram illustrates the systematic approach taken in the research, highlighting the integration of scientific logic in quality assessment.
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Quality by design for pharmaceuticals, Anita Anand
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- Année de publication
- 2020
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