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Qualification of impurities based on metabolite data.
Weidolf, Lars; Andersson, Thomas; Bercu, Joel P; Brink, Andreas; Glowienke, Susanne; Harvey, James; Hayes, Martin A; Jacques, Pascale; Lu, Chuang; Manevski, Nenad; Muster, Wolfgang; Nudelman, Raphael; Ogilvie, Ron; Ottosson, Jenny; Teasdale, Andrew; Trela, Bruce.
Affiliation
  • Weidolf L; DMPK, Research and Early Development Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. Electronic address: Lars.Weidolf@astrazeneca.com.
  • Andersson T; Pharmaceutical Technology and Development, AstraZeneca, SE-43183, Mölndal, Sweden. Electronic address: Thomas.Andersson@astrazeneca.com.
  • Bercu JP; Gilead Sciences, Nonclinical Safety and Pathobiology, 333 Lakeside Drive, Foster City, CA, USA. Electronic address: Joel.Bercu@gilead.com.
  • Brink A; Pharmaceutical Sciences, Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070, Basel, Switzerland. Electronic address: Andreas.Brink@roche.com.
  • Glowienke S; NIBR Pre-clinical Safety, Novartis AG, Klybeckstrasse, 4057, Basel, Switzerland. Electronic address: Susanne.Glowienke@novartis.com.
  • Harvey J; GSK R&D, Park Road, Ware, Hertfordshire, SG120DP, United Kingdom. Electronic address: James.S.Harvey@gsk.com.
  • Hayes MA; Hit Discovery, Discovery Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. Electronic address: Martin.Hayes@astrazeneca.com.
  • Jacques P; UCB Pharma Sprl, Braine-l'Alleud, Belgium. Electronic address: Pascale.Jacques@ucb.com.
  • Lu C; DMPK, Sanofi, 153 Second Avenue, Waltham, MA, 02451, USA. Electronic address: Chuang.Lu@sanofi.com.
  • Manevski N; UCB Celltech, SL13WE, Slough, United Kingdom. Electronic address: Nenad.Manevski@ucb.com.
  • Muster W; Pharmaceutical Sciences, Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070, Basel, Switzerland. Electronic address: Wolfgang.Muster@roche.com.
  • Nudelman R; Chemical & Computational Toxicology, Teva Pharmaceutical Industries Ltd., Israel. Electronic address: Raphael.Nudelman@teva.co.il.
  • Ogilvie R; Global Regulatory CMC, Pfizer R&D, United Kingdom. Electronic address: Ron.Ogilvie@pfizer.com.
  • Ottosson J; Early Product Development, Pharmaceutical Sciences, R&D, AstraZeneca, Gothenburg, Sweden. Electronic address: Jenny.Ottosson@astrazeneca.com.
  • Teasdale A; Chemical Development, Pharmaceutical Technology & Development, AstraZeneca, Macclesfield Campus, SK102NA, United Kingdom. Electronic address: Andrew.Teasdale@astrazeneca.com.
  • Trela B; Preclinical Safety, AbbVie, North Chicago, IL, 60064, USA. Electronic address: Bruce.A.Trela@abbvie.com.
Regul Toxicol Pharmacol ; 110: 104524, 2020 Feb.
Article in En | MEDLINE | ID: mdl-31734179
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pharmaceutical Preparations / Drug Contamination Limits: Animals / Humans Language: En Journal: Regul Toxicol Pharmacol Year: 2020 Document type: Article
Fulltext
Print
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pharmaceutical Preparations / Drug Contamination Limits: Animals / Humans Language: En Journal: Regul Toxicol Pharmacol Year: 2020 Document type: Article