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Omission of USP Biological Reactivity Tests, In Vivo 〈88〉—Replacing 〈88〉 with an Expanded Biological Reactivity Tests, In Vitro 〈87〉 and a Risk-Based Evaluation Framework

Desmond G. Hunt, Douglas E. Kiehl, Michael Eakins, Renaud Janssen

Correspondence should be addressed to: Desmond G. Hunt, Senior Principal Scientist, US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; email: dgh@usp.org.

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