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International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines.
Keire, David A; Bream, Robert; Wollein, Uwe; Schmaler-Ripcke, Jeannette; Burchardt, Annette; Conti, Massimiliano; Zmyslowski, Adam; Keizers, Peter; Morin, Justin; Poh, Jalene; George, Mark; Wierer, Michael.
Affiliation
  • Keire DA; Office of Testing and Research, Office of Pharmaceutical Quality, Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO, 63110, USA. David.Keire@fda.hhs.gov.
  • Bream R; European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
  • Wollein U; Bayerisches Landesamt Für Gesundheit Und Lebensmittelsicherheit, LGL, Veterinärstr. 2, 85764, Oberschleissheim, Germany.
  • Schmaler-Ripcke J; Chemisches und Veterinäruntersuchungsamt Karlsruhe, CVUA Karlsruhe, Weißenburger Str. 3, 76187, Karlsruhe, Germany.
  • Burchardt A; Institute for Pharmaceutical and Applied Analytics - InphA GmbH, Emil-Sommer-Strasse 7, 28329, Bremen, Germany.
  • Conti M; Schweizerisches Heilmittelinstitut (Biol. & Pharm.), OMCL Swissmedic, Hallerstrasse 7, 3012, Bern, Switzerland.
  • Zmyslowski A; National Medicines Institute, NIL, 30/34 Chelmska Street, 00-725, Warsaw, Poland.
  • Keizers P; Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3721 MA, Bilthoven, The Netherlands.
  • Morin J; Health Canada, 2301 Midland Avenue, Room 200-59, Toronto, M1P 4R7, Canada.
  • Poh J; Health Sciences Authority, 11 Outram Road, Bukit Merah, 169078, Singapore.
  • George M; TGA Laboratories, 136 Narrabundah Lane, Symonston, A.C.T, 2606, Australia.
  • Wierer M; European Directorate for the Quality of Medicines & HealthCare, 7 Allée Kastner CS 30026, 67081, Strasbourg, France.
AAPS J ; 24(3): 56, 2022 04 21.
Article in En | MEDLINE | ID: mdl-35449372
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Metformin / Nitrosamines Limits: Humans Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2022 Document type: Article Affiliation country: Country of publication:
Fulltext
Add to My VHL
Print
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Metformin / Nitrosamines Limits: Humans Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2022 Document type: Article Affiliation country: Country of publication: