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>> Literature
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Q4B Annex 7 (R2) Dissolution Test General Chapter
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Q4B Annex 9 (R1) Tablet Friability General Chapter
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Q4B Annex 10 (R1) Polyacrylamide Gel Electrophoresis General Chapter
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Q4B Annex 11 Capillary Electrophoresis General Chapter
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Q4B Annex 12 Analytical Sieving General Chapter
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Q4B Annex 13 Bulk Density and Tapped Density of Powders General Chapter
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Q4B Annex 14 Bacterial Endotoxins Test General Chapter
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Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
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Q4B Frequently Asked Questions
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Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
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Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
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Q5C Stability Testing of Biotechnological/Biological Products
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Derivation and Characterisation of Cell Substrates Used for Production of BiotechnologicalBiologica
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Comparability of BiotechnologicalBiological Products Subject to Changes in their Manufacturing Proce
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Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Produc
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Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
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Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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Q7 Questions and Answers
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Q8(R2) Pharmaceutical Development
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Q9（R1）Quality Risk Management
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