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A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products.
Rhieu, Steve Y; Anderson, David D; Janoria, Kumar.
Affiliation
  • Rhieu SY; Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA. steve.rhieu@fda.hhs.gov.
  • Anderson DD; Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Janoria K; Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
AAPS J ; 22(5): 100, 2020 08 02.
Article in En | MEDLINE | ID: mdl-32743675
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Full text: 1 Database: MEDLINE Main subject: Drug Industry / Legislation, Drug Type of study: Prognostic_studies Language: En Year: 2020 Type: Article
Fulltext
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PubMed Links
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Full text: 1 Database: MEDLINE Main subject: Drug Industry / Legislation, Drug Type of study: Prognostic_studies Language: En Year: 2020 Type: Article