Transcription of Recommendations for the Assessment of Blend …
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Recommendations for the Assessment of Blend …
Recommendations for the Assessment of Blend and Content Uniformity: Modern Approaches to Sampling and Testing James K. Drennen, III. Unprecedented Change Technology Philosophy/Regulatory Methodology QbD approach Risk Assessment Design Space Efficient Calibration Calibration Management Automation and Control Performance based ( clinically relevant ) quality specifications and Quality Metrics 2. Regulatory Draft Guidance for industry, Powder Blends and Finished Dosage Units- Stratified In-Process Dosage Unit Sampling and Assessment . Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), October 2003; withdrawn.
Recommendations for the Assessment of Blend and Content Uniformity: Modern Approaches to Sampling and Testing James K. Drennen, III drennen@duq.edu
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