ICH Step 4 Guidelines |
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ICH Harmonised Tripartite Guideline for Good Clinical Practice (with EC Directive)
ISBN 1-874409-74-9 |
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ICH Harmonised Tripartite Guideline for Good Clinical Practice
ISBN 1-874409-47-1 |
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ICH Harmonised Tripartite Guideline for General Considerations for Clinical Trials
ISBN 1-874409-91-9 |
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ICH Harmonised Tripartite Guideline for Data Elements for Transmission of Individual Case Safety Reports
ISBN 1-874409-02-1 |
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ICH Harmonised Tripartite Guideline for Statistical Principles for Clinical Trials
ISBN 1-874409-07-2 |
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Russian Translation of ICH GCP Guidelines
This booklet is a translation of the ICH GCP guidelines, which provides a model for the EU, Japan and USA on how to achieve mutual acceptance of clinical trial data by regulatory bodies. ISBN 1-874409-73-0 |