Abstract
The development of a guideline for nonclinical testing strategies for anticancer drugs and biologicals was initiated by the International Conference on Harmonisation (ICH) in 2007. The rationale for developing this guideline was that separate regional guidelines were being or had been developed. By nature, ICH guidelines tend to describe regulatory recommendations rather than the underlying rationale of the recommendations. The purpose of this chapter is not to discuss the document per se but to describe the perspective of regulators on some of the topics discussed during the deliberations in developing the ICH S9 guideline, focusing on major changes to drug development compared to past practices, and to illustrate the principles underlying the recommendations and alternative views that were considered.
This article reflects the personal opinions of the authors and does not necessarily reflect the Âorganizations they represent.
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Acknowledgments
The authors wish to thank and acknowledge the helpful discussions, hard work, and contributions of the members of the ICH S9 EWG in the development of the guidance. These members did not participate in the writing of this article: Mikael Andersson, Marco Bughera, Osamu Fueki, James Green, Shuichi Kai, Daniel Lapadula, Tatiana Lejen, Helen Mao, Dai Nakae, Takahiro Nakazawa, Chihiro Nishimura, Anne Pilaro, Vijayapal Reddy, Fumio Sagami, Hermann Schweinfurth, Mercedes Serabian, Beat Schmid, and Ulla Wändel-Liminga.
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Leighton, J.K., Olejniczak, K., Onodera, H. (2013). ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals: A Perspective from Regulators on the Development of the Guideline. In: van der Laan, J., DeGeorge, J. (eds) Global Approach in Safety Testing. AAPS Advances in the Pharmaceutical Sciences Series, vol 5. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-5950-7_13
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DOI: https://doi.org/10.1007/978-1-4614-5950-7_13
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