Analytical Procedure Validation for I 6.1.3.3 Complementary Medicines I 6.2.7.8 I 6.2.10.2 I A1.2.4 App 3 II 5.1.3.3 II 5.2.7.7 II 5.2.10.2 IV 19.5 Note for Guidance on the I 7.5.1.3 Investigation of Bioavailability and Bioequivalence* *Contains an Australian specific notation Note for Guidance on Evaluation of I 6.2.10.2 Stability Data (ICH Topic Q1E) II 5.2.10.2 III 4.3.2 Note for Guidance on Specifications: I 6 Test Procedures for Herbal Drugs, II 5 Herbal Drug Preparations and Herbal Medicinal Products III 4 IV 19 substance guidelines Referenced in the ARGCM Guideline name Guideline identifier Part Section Note for Guidance on Stability Data I 6.2.10.2 Package for Registration in Climatic Zones III and IV (ICH Topic Q1 F) Adopted by the – TGA with annotation Note for Guidance on Impurities: I 6.2.7.3 Testing Impurities in New Drug Substances (ICH Topic Q3A(R))
Analytical Procedure Validation for Complementary Medicines I 6.1.3.3 I 6.2.7.8 I 6.2.10.2 I App 3 A1.2.4 II 5.1.3.3 II 5.2.7.7 II 5.2.10.2 IV 19.5 Note for Guidance on the Investigation of Bioavailability and Bioequivalence* *Contains an Australian specific notation I 7.5.1.3 Note for Guidance on Evaluation of Stability Data (ICH Topic Q1E) I 6.2.10.2 II 5.2.10.2 III 4.3.2 Note for Guidance on Specifications: Test Procedures for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products I 6 II 5 III 4 IV 19 substance guidelines Guideline name Guideline identifier Referenced in the ARGCM Part Section Note for Guidance on Stability Data Package for Registration in Climatic Zones III and IV (ICH Topic Q1 F) – Adopted by the TGA with annotation I 6.2.10.2 Note for Guidance on Impurities: Testing Impurities in New Drug Substances (ICH Topic Q3A(R)) I 6.2.7.3
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