Titlebook: Global Approach in Safety Testing; ICH Guidelines Expla Jan Willem van der Laan,Joseph J. DeGeorge Book 2013 American Association of Pharma

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ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals: A Perspective from Regulators on the

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Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: ICH M3 an

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AAPS Advances in the Pharmaceutical Sciences Series386019.jpg

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978-1-4899-9407-3American Association of Pharmaceutical Scientists 2013

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Confidential

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Book 2013esting, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been

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