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Control of N-nitrosamine Impurities in Drug Products: Progressing the Current CPCA Framework and Supporting the Derivation of Robust Compound Specific Acceptable Intakes

David J. Ponting,Andreas Czich,Susan P. Felter,Susanne Glowienke,James S. Harvey,Raphael Nudelman,Joerg Schlingemann,Stephanie Simon,Graham F. Smith,Andrew Teasdale,Robert Thomas

REGULATORY TOXICOLOGY AND PHARMACOLOGY（2025）

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