Q1a(R2)_2003_新原料药与新制剂稳定性设计研究(中英文).docVIP

专业技术资料整理分享 WORD格式可编辑 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1A(R2) Current Step 4 version dated 6 February 2003 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the Eu