Transcription of GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8
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GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8 Current Step 4 version dated 17 July 1997 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 European Union, Japan and USA.
3.1.2 Quality of Investigational Medicinal Products Formulations used in clinical trials should be well characterised, including ... 3.1.3 Phases of Clinical Development Clinical drug development is often described as consisting of four temporal phases (Phase I-IV). It is important to recognise that the phase of development provides an
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