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Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals.
Horne, Stephen; Vera, Matthew D; Nagavelli, Laxma R; Sayeed, Vilayat A; Heckman, Laurel; Johnson, Deborah; Berger, Dan; Yip, Yean Yean; Krahn, Carolina Lopes; Sizukusa, Leticia Oyamada; Rocha, Nayrton Flavio Moura; Bream, Robert N; Ludwig, Joachim; Keire, David A; Condran, Gary.
Afiliação
  • Horne S; Health Canada, Ottawa, Ontario, Canada K1A 0K9. Electronic address: stephen.horne@hc-sc.gc.ca.
  • Vera MD; US Food and Drug Administration (US FDA), Silver Spring, MD, 20993, USA.
  • Nagavelli LR; US Food and Drug Administration (US FDA), Silver Spring, MD, 20993, USA.
  • Sayeed VA; US Food and Drug Administration (US FDA), Silver Spring, MD, 20993, USA.
  • Heckman L; US Food and Drug Administration (US FDA), Silver Spring, MD, 20993, USA.
  • Johnson D; US Food and Drug Administration (US FDA), Silver Spring, MD, 20993, USA.
  • Berger D; US Food and Drug Administration (US FDA), Silver Spring, MD, 20993, USA.
  • Yip YY; Health Sciences Authority (HSA), Singapore 138667.
  • Krahn CL; Agência Nacional de Vigilância Sanitária (ANVISA), Brasília/DF, Brazil.
  • Sizukusa LO; Agência Nacional de Vigilância Sanitária (ANVISA), Brasília/DF, Brazil.
  • Rocha NFM; Agência Nacional de Vigilância Sanitária (ANVISA), Brasília/DF, Brazil.
  • Bream RN; European Medicines Agency (EMA, EU), Amsterdam, the Netherlands.
  • Ludwig J; Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany.
  • Keire DA; US Food and Drug Administration (US FDA), St Louis, MO, 63110, USA.
  • Condran G; Health Canada, Ottawa, Ontario, Canada K1A 0K9.
J Pharm Sci ; 112(5): 1166-1182, 2023 05.
Article em En | MEDLINE | ID: mdl-36599405
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Nitrosaminas Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Nitrosaminas Idioma: En Ano de publicação: 2023 Tipo de documento: Article