ICH指导原则共180条
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Impurities in New Drug Substances
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Impurities in New Drug Products
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Guideline for Elemental Impurities
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Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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Frequently Asked Questions
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Evaluation of Stability Data
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Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
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Dissolution Test General Chapter
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Disintegration Test General Chapter
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Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological_Biological Entities)
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Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological_Biological Products
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Comparability of Biotechnological_Biological Products Subject to Changes in their Manufacturing Process
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Capillary Electrophoresis General Chapter
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Bulk Density and Tapped Density of Powders General Chapter
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Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
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Bacterial Endotoxins Test General Chapter
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Analytical Sieving General Chapter
有效性
非抗心律失常药物致QT_QTc间期延长及潜在心律失常作用的临床评价
有效性
药物进行人体临床试验和上市许可申请的非临床安全性研究指导原则