The Complete Stability Testing :
Strategies, Requirements, Basic Principles, Performance,
Documents
Istanbul 15.-16. January 2004 Dr. Wolfgang Grimm
Kılavuzlar ve Diğer Dokümanlar
“The Complete Stability Testing”
1. Guidelines for Stability
Testing
1.1
Stability
Testing of New Drug Substances and Products, ICH Q1A(R2)
1.2
Photostability
Testing of New Substances and Products, ICH Q1B
1.3
Stability
Testing, Requirements for New Dosage Forms, ICH Q1C
1.3.1
Bracketing and Matrixing Designs
for Stability Testing of New Drug Substances and Products, ICH Q1D
1.5 Evaluation
of stability Data ICH Q1E
1.6 Stability
Data Package for Registration in Climatic Zones III and IV, ICH Q1F
1.7 Validation
of Analytical Methods Definitions and Terminology, ICH Q2A
1.8 Validation
of Analytical Procedures Methodology, ICH Q2B
1.9 Impurities
in New Drug Substances, ICH Q3A(R)
1.10 Impurities
in New Drug Products, ICH Q3B( R)
1.11 Impurities
Residual Solvents, ICH Q3C
1.12 Specifications,
Test Procedure sand Acceptance Criteria for New Drug Substances and New Drug
Products; Chemical Substances, ICH Q6A
1.13. Common
Technical Document for Registration of Pharmaceuticals for human use,
Organization CTD, ICH M 4, Quality, M4Q
1.14 Stability
Testing for a Type II Variation to the Marketing Authorization in the EU, CPMP/QWP/576/9
1.15 Stability Testing of Existing Active Substances and Related
Finished Products CPMP/QMP/122/02 (Revision of CPMP/QWP/556/96)
4. Documents
4.2 Validation
Report
4.3 Stability Report: Stability Profile of Drug Substance
4.4 Stability Report for Clinical Samples
4.4.1 Phase
I
4.4.2 Phase II
4.4.3 Phase III
4.5 Stability Report: Stability Profile of Drug Product
4.7 Stability Report Drug Product for Registration