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A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies.
Barber, Chris; Antonucci, Vincent; Baumann, Jens-Christoph; Brown, Roland; Covey-Crump, Elizabeth; Elder, David; Elliott, Eric; Fennell, Jared W; Gallou, Fabrice; Ide, Nathan D; Jordine, Guido; Kallemeyn, Jeffrey M; Lauwers, Dirk; Looker, Adam R; Lovelle, Lucie E; McLaughlin, Mark; Molzahn, Robert; Ott, Martin; Schils, Didier; Oestrich, Rolf Schulte; Stevenson, Neil; Talavera, Pere; Teasdale, Andrew; Urquhart, Michael W; Varie, David L; Welch, Dennie.
Afiliación
  • Barber C; Lhasa Limited, Leeds, UK. Electronic address: chris.barber@lhasalimited.org.
  • Antonucci V; Merck Sharp & Dohme, Rahway, NJ, USA.
  • Baumann JC; F. Hoffmann-La Roche Ltd., Basel, Switzerland.
  • Brown R; Pfizer, Sandwich, UK.
  • Covey-Crump E; Lhasa Limited, Leeds, UK.
  • Elder D; Consultant, Hertford, Hertfordshire, UK.
  • Elliott E; Takeda Pharmaceuticals, Cambridge, MA, USA.
  • Fennell JW; Eli Lilly and Co., Indianapolis, IN, USA.
  • Gallou F; Novartis, Basel, Switzerland.
  • Ide ND; AbbVie, North Chicago, IL, USA.
  • Jordine G; Novartis, Basel, Switzerland.
  • Kallemeyn JM; AbbVie, North Chicago, IL, USA.
  • Lauwers D; Janssen Pharmaceutica NV, Beerse, Belgium.
  • Looker AR; Vertex Pharmaceuticals, Boston, MA, USA.
  • Lovelle LE; Novartis, Basel, Switzerland.
  • McLaughlin M; Merck Sharp & Dohme, Rahway, NJ, USA.
  • Molzahn R; Excella GmbH & Co. KG, Feucht, Germany.
  • Ott M; Lhasa Limited, Leeds, UK.
  • Schils D; Galapagos NV, Mechelen, Belgium.
  • Oestrich RS; F. Hoffmann-La Roche Ltd., Basel, Switzerland.
  • Stevenson N; GlaxoSmithKline, Stevenage, Hertfordshire, UK.
  • Talavera P; Esteve Química, Barcelona, Spain.
  • Teasdale A; AstraZeneca, Macclesfield, Cheshire, UK.
  • Urquhart MW; GlaxoSmithKline, Stevenage, Hertfordshire, UK.
  • Varie DL; Eli Lilly and Co., Indianapolis, IN, USA.
  • Welch D; AbbVie, North Chicago, IL, USA.
Regul Toxicol Pharmacol ; 90: 22-28, 2017 Nov.
Article en En | MEDLINE | ID: mdl-28822875
ABSTRACT
The ICH M7 Option 4 control of (potentially) mutagenic impurities is based on the use of scientific principles in lieu of routine analytical testing. This approach can reduce the burden of analytical testing without compromising patient safety, provided a scientifically rigorous approach is taken which is backed up by sufficient theoretical and/or analytical data. This paper introduces a consortium-led initiative and offers a proposal on the supporting evidence that could be presented in regulatory submissions.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Contaminación de Medicamentos / Tecnología Farmacéutica / Pruebas de Mutagenicidad / Mutágenos Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Regul Toxicol Pharmacol Año: 2017 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Contaminación de Medicamentos / Tecnología Farmacéutica / Pruebas de Mutagenicidad / Mutágenos Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Regul Toxicol Pharmacol Año: 2017 Tipo del documento: Article