ICH指导原则共180条
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Sterility Test General Chapter
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Stability Testing _ Photostability Testing of New Drug Substances and Products
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Stability Testing of New Drug Substances and Products
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Stability Testing for New Dosage Forms
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Specifications _ Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products_ Chemical Substances
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Residue on Ignition_Sulphated Ash General Chapter
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Questions and Answers_ Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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Questions & Answers_ Selection and Justification of Starting Materials for the Manufacture of Drug Substances
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Quality Risk Management
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Quality of Biotechnological Products_ Stability Testing of Biotechnological_Biological Products
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Quality of Biotechnological Products_ Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
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Q8_Q9_Q10 Questions and Answers
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Polyacrylamide Gel Electrophoresis General Chapter
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Pharmaceutical Quality System
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Pharmaceutical Development
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Microbiological Examination of Non-Sterile Products_ Tests for Specified Micro-Organisms General Chapter
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Microbiological Examination of Non-Sterile Products_ Microbial Enumeration Tests General Chapter
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Microbiological Examination of Non-Sterile Products_ Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
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Impurities_ Guideline for Residual Solvents