Скачать или смотреть Pharmaceutical Drug product Development & Optimization (QbD Vs QbT) Part 02

In the Pharmaceutical field, ‘quality’ represents an acceptably low risk of failing to achieve the desired clinical attributes. The suitability of either a drug substance or a drug product for its intended use. This term includes such attributes as identity, strength, and purity
A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. QbD requires the product and process performance characteristics to be designed scientifically to meet specific objectives, but not to be empirically derived from performance of test batches as it is done for QbT.
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