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- W1938851020 abstract "Abstract In the United States, biopharmaceutical products have been developed in accordance with ICH S6 since its publication in 1997. The ICH S6 document creates a case‐by‐case, science‐driven approach to biotechnology preclinical product development, providing information and for designing and conducting clinical trials. This article reviews specific sections and considerations of the ICH S6 document and discuss how this guidance has been implemented in the United States." @default.
- W1938851020 created "2016-06-24" @default.
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- W1938851020 date "2010-03-15" @default.
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- W1938851020 title "Implementation of ICH S6: US Perspective" @default.
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- W1938851020 doi "https://doi.org/10.1002/9780470571224.pse165" @default.
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