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Testing for carcinogenicity is a key toxicological test that supports marketing authorization and an important part of nonclinical safety studies for pharmaceuticals. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) S1B “Testing for carcinogenicity of pharmaceuticals” provides recommendations on approaches for evaluating the carcinogenic potential of pharmaceuticals which can include the conduct of a 2-year rat carcinogenicity study. With the application of the ICH S1B (R1) “Addendum to testing for carcinogenicity for pharmaceuticals” in China, sponsors are allowed to use the weight of evidence (WoE) method rather than the conventional 2-year rat carcinogenicity study, a more scientific and comprehensive assessment of the carcinogenic potential of certain molecules specified in ICH S1A “Guideline on the need for carcinogenicity studies of pharmaceuticals”. This addendum identifies key factors supporting WoE assessment and emphasizes the importance of survey investigative studies and emerging technology in assessing human carcinogenic risks. This article discusses the background information on the development of ICH S1B (R1), main technical issues, and follow-up work, in order to facilitate the understanding and implementation of this guideline.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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