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Observation and Mitigation of Lamellar Silica Particles Formed in Pharmaceutical Products Packaged in Glass Vials.
Nashed-Samuel, Yasser; Gastwirt, Jeremy; Kotia, Ruchi B; Moore, Stephanie; Masatani, Peter; Torraca, Gianpiero; Goss, Monica; Dolan, David G; Akers, Michael; Padala, Chakradhar; Wypych, Jette; Semin, David J.
Afiliação
  • Nashed-Samuel Y; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States. Electronic address: snashed@amgen.com.
  • Gastwirt J; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Kotia RB; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Moore S; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Masatani P; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Torraca G; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Goss M; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Dolan DG; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Akers M; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Padala C; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Wypych J; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
  • Semin DJ; Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
J Pharm Sci ; 111(12): 3275-3286, 2022 12.
Article em En | MEDLINE | ID: mdl-36116524

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dióxido de Silício / Embalagem de Medicamentos Tipo de estudo: Prognostic_studies Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dióxido de Silício / Embalagem de Medicamentos Tipo de estudo: Prognostic_studies Idioma: En Ano de publicação: 2022 Tipo de documento: Article