The Process and Challenges of Deriving Exposure-Based Limits for Components and Impurities Present in Pharmaceutical Drug Products With Case Studies for an Excipient, a Genotoxic Impurity, and an Immunomodulator

Welsh B.; Kimzey A.; Lansita J.

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The Process and Challenges of Deriving Exposure-Based Limits for Components and Impurities Present in Pharmaceutical Drug Products With Case Studies for an Excipient, a Genotoxic Impurity, and an Immunomodulator

机译：衍生基于曝光的曝光范围的曝光范围和药物药品中的杂质的限制，其具有赋形剂，遗传毒性杂质和免疫调节剂的案例研究

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来源
《International journal of toxicology》 |2018年第1期|共1页
作者
Welsh B.; Kimzey A.; Lansita J.;
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ToxStrategies Inc Katy TX USA;

ToxStrategies Inc Katy TX USA;

ToxStrategies Inc Katy TX USA;

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原文格式 PDF
正文语种 eng
中图分类毒物学（毒理学）;
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1. The Process and Challenges of Deriving Exposure-Based Limits for Components and Impurities Present in Pharmaceutical Drug Products With Case Studies for an Excipient, a Genotoxic Impurity, and an Immunomodulator [J] . Welsh B., Kimzey A., Lansita J. International journal of toxicology . 2018,第1期

机译：衍生基于曝光的曝光范围的曝光范围和药物药品中的杂质的限制，其具有赋形剂，遗传毒性杂质和免疫调节剂的案例研究
2. Risk Assessment of Genotoxic Impurities in Marketed Compounds Administered over a Short-Term Duration: Applications to Oncology Products and Implications for Impurity Control Limits [J] . Courtney M. Callis, Joel P. Bercu, Keith M. DeVries Organic process research & development . 2010,第4期

机译：短期内施用的市售化合物中遗传毒性杂质的风险评估：肿瘤产品的应用及其对杂质控制限值的影响
3. A perspective on testing of existing pharmaceutical excipients for genotoxic impurities. [J] . Brusick DJ Regulatory Toxicology and Pharmacology: RTP . 2009,第2期

机译：关于测试现有药物赋形剂中遗传毒性杂质的观点。
4. Ion Mobility Spectrometry (IMS) for Trace Analysis of Potential Genotoxic Impurity (PGI) in Pharmaceutical Products [C] . Yaning Ma American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics . 2010

机译：离子迁移光谱法（IMS）用于药品中潜在遗传毒性杂质（PGI）的痕量分析
5. Implementation into DIVIMP of a drift-kinetic model derived from the Fokker-Planck equation to examine the parallel-to-B velocity component of impurity ions in divertor-tokamak plasmas. [D] . Schwanke, Peter. 2001

机译：从Fokker-Planck方程导出的漂移动力学模型在DIVIMP中的实现，以检查偏滤托卡马克等离子体中杂质离子的平行于B速度分量。
6. Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape [O] . Karen M. Alsante, Kim C. Huynh-Ba, Steven W. Baertschi, 2014

机译：产品开发的最新趋势以及活性药物成分（API）和药物产品中杂质的监管问题。第2部分：药品中杂质的安全注意事项和杂质状况调查
7. INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINES ON THE LIMITS OF GENOTOXIC IMPURITIES IN DRUG PRODUCT [O] . Malik Ajay, Thukral Kapil, Kumar Tarun, 2012

机译：关于药物产品中遗传毒性限值协调的国际会议指南

The Process and Challenges of Deriving Exposure-Based Limits for Components and Impurities Present in Pharmaceutical Drug Products With Case Studies for an Excipient, a Genotoxic Impurity, and an Immunomodulator

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