The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development.
第一作者:
Krista L,Dobo
第一单位:
Pfizer Global Research and Development, Worldwide Safety Sciences, Genetic Toxicology, Groton, CT, USA. krista.l.dobo@pfizer.com
作者:
医学主题词
药物污染(Drug Contamination);诱变力试验(Mutagenicity Tests);诱变剂(Mutagens);药用制剂(Pharmaceutical Preparations);危险性评估(Risk Assessment);构效关系(Structure-Activity Relationship)
DOI
10.1016/j.yrtph.2006.01.004
PMID
16464524
发布时间
2006-04-03
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