ROUTINE METHOD DEVELOPMENT: PERILS, PITFALLS AND TRIUMPHS

机译：常规方法开发：危险，陷阱和胜利

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Routine leachables or extractables methods may be developed for a variety of reasons: measurement of chemicals that may pose a safety concern, monitoring material consistency, etc. The decision to develop a routine method can be taken using a risk-based approach. Method development activities require careful consideration of the sample preparation and analytical techniques. The implementation of a three tiered DoE approach to method development can significantly improve the method development process. A few examples will be used to illustrate the challenges and opportunities associated with this approach to method development for different types of materials used in OINDP.

机译：可以出于各种原因开发常规浸出物或提取物方法：可以使用基于风险的方法来占据安全问题，监测材料一致性等化学品的测量。方法开发活动需要仔细考虑样品制备和分析技术。实施三层DOE方法的方法开发可以显着改善方法开发过程。一些例子将用于说明与oINDP中使用的不同类型材料的方法开发方法相关的挑战和机会。

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《Rapra International Conference on Extractables Leachables for Pharmaceutical Products》|2010年||共7页
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Cheryl L.M. Stults;
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中图分类合成树脂与塑料工业;
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ROUTINE METHOD DEVELOPMENT: PERILS, PITFALLS AND TRIUMPHS

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