Structured content and data management-enhancing acceleration in drug development through efficiency in data exchange.

Beierle, Jill; Algorri, Marquerita; Cortés, Marisol; Cauchon, Nina S; Lennard, Andrew; Kirwan, J Paul; Oghamian, Shirley; Abernathy, Michael J

Beierle, Jill; Algorri, Marquerita; Cortés, Marisol; Cauchon, Nina S; Lennard, Andrew; Kirwan, J Paul; Oghamian, Shirley; Abernathy, Michael J.

Afiliación

Beierle J; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA.
Algorri M; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA.
Cortés M; Department of Physiology, Johns Hopkins University School of Medicine, Baltimore, MD 21205 USA.
Cauchon NS; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA.
Lennard A; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA.
Kirwan JP; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA.
Oghamian S; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA.
Abernathy MJ; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA.

AAPS Open ; 9(1): 11, 2023.

Article en En | MEDLINE | ID: mdl-37193559

Palabras clave

Acceleration pathway; Automation; Chemistry manufacturing and controls; Cloud-based systems; Regulatory science; Stability; Standards; Structure; Structured content data management

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Texto completo: 1 Bases de datos: MEDLINE Idioma: En Revista: AAPS Open Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo

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XML

PubMed Links

Buscar en Google

Texto completo: 1 Bases de datos: MEDLINE Idioma: En Revista: AAPS Open Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos