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Observation and Mitigation of Leachables from Non-Product Contact Materials in Electromechanical Delivery Devices for Biotechnology Products.
Liu, Jian; Ronk, Michael; Luo, Yanxin; Wypych, Jette; Zhang, Zhongqi; Perez-Pacheco, Joel; Jin, Ellen; Shah, Bhavana; Richardson, Jason; Li, Kim; Semin, David; Nashed-Samuel, Yasser.
Affiliation
  • Liu J; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: jialiu@amgen.com.
  • Ronk M; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Luo Y; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Wypych J; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Zhang Z; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Perez-Pacheco J; Device Technologies, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Jin E; Device Technologies, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Shah B; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Richardson J; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Li K; Environment, Health, Safety and Sustainability, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Semin D; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Nashed-Samuel Y; Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: snashed@amgen.com.
J Pharm Sci ; 110(12): 3794-3802, 2021 12.
Article in En | MEDLINE | ID: mdl-34390741
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Full text: 1 Database: MEDLINE Main subject: Quality of Life / Pharmaceutical Preparations Type of study: Guideline Limits: Humans Language: En Journal: J Pharm Sci Year: 2021 Type: Article
Fulltext
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Full text: 1 Database: MEDLINE Main subject: Quality of Life / Pharmaceutical Preparations Type of study: Guideline Limits: Humans Language: En Journal: J Pharm Sci Year: 2021 Type: Article