An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment.

Autor: Boetzel R; Pfizer Inc., Sandwich CT13 9NJ, UK., Ceszlak A; Polpharma SA, Starogard Gdański 83-200, Poland., Day C; AstraZeneca, Macclesfield SK10 2NA, UK., Drumm P; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936., Gil Bejar J; B. Braun Melsungen AG, 34212 Melsungen, Germany., Glennon J; GlaxoSmithKline, Zebulon, North Carolina 27597., Harris L; Pfizer Inc., Sandwich CT13 9NJ, UK., Heghes CI; Lhasa Limited, Leeds LS11 5PS, UK., Horga R; Apotex Inc., Richmond Hill L4C 5H2, Canada., Jacobs PL; MSD, Oss 5342 CC, The Netherlands., Keurentjes WJTM; MSD, Oss 5342 CC, The Netherlands., King F; GlaxoSmithKline, Stevenage SG1 2NY, UK., Lee CW; Pfizer Inc., Groton, Connecticut 06340., Lewen N; Bristol-Myers Squibb, New Brunswick, New Jersey 08903., Marchant CA; Lhasa Limited, Leeds LS11 5PS, UK. Electronic address: carol.marchant@lhasalimited.org., Maris FA; MSD, Oss 5342 CC, The Netherlands., Nye W; Lhasa Limited, Leeds LS11 5PS, UK., Powell S; Pfizer Inc., Sandwich CT13 9NJ, UK., Rockstroh H; Hoffmann-La Roche AG, Basel CH-4070, Switzerland., Rutter L; GlaxoSmithKline, Ware SG12 0DP, UK., Schweitzer M; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936., Shannon E; Takeda Ireland Limited, Dublin 22, Ireland., Smallshaw L; UCB Biopharma SPRL, Braine-l'Alleud B-1420, Belgium., Teasdale A; AstraZeneca, Macclesfield SK10 2NA, UK., Thompson S; AstraZeneca, Macclesfield SK10 2NA, UK., Wilkinson D; Lhasa Limited, Leeds LS11 5PS, UK.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2018 Sep; Vol. 107 (9), pp. 2335-2340. Date of Electronic Publication: 2018 Apr 18.