Q1d 新原料药及其制剂的稳定性试验中扩号法和矩阵化设计的应用.pdf

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products Step 2 9 November 2000 1 2 3 This draft guidance, when finalized, will represent the Food and Drug Administrations (FDAs) current 4 5 thinking on this topic. It does not create or confer any rights for or on any person and does not operate 6 to bind FDA or the public. An alternative approach may be used if such approach satisfies the 7 requirements of the applicable statutes and regulations. 8 9 INTRODUCTION 10 11 1.1 Objectives of the Guideline 12 13 The objective of this guideline is to provide harmonised guidance on the application of bracketing 14 and matrixing for stability studies conducted in accordance with principles outlined in the ICH 15 Q1A Harmonised Tripartite guideline covering Stability Testing of New Drug Substances and 16 Products (hereafter referred to as the parent guideline). 17 18 1.2 Background 19 20 Q1A notes that the use of matrixing and bracketing can be applied, if justified, to the testing of 21 new drug substances and products, but provides no further guidance on the subject. 22 23 1.3 Scope of the guideline 24 25 This document is an annex to the parent guideline and addresses recommendations for 26 bracketing and matrixing study designs . Specific principles are provided in this guideline for 27 situations in which bracketing or matrixing can be applied without further justification. In other 28 circumstances, bracketing or matr