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Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 11: Capillary Electrophoresis General Chapter
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Q4B Annex 9: Tablet Friability General Chapter
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Q4B Annex 8: Sterility Test General Chapter
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Q4B Annex 7 (R2): Dissolution Test General Chapter
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Q4B Annex 5: Disintegration Test General Chapter
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S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology
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S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
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S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
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Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations
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