This article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
Elisabeth Corbett
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Elisabeth Corbett is associate director, Global Regulatory Sciences, CMC, Bristol-Myers Squibb.
Articles by Elisabeth Corbett
The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.
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