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Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over in vivo release testing of vaccines.
Hoefnagel, Marcel H N; Stickings, Paul; Smith, Dean; Jungbäck, Carmen; Van Molle, Wim; Tesolin, Lorenzo.
Affiliation
  • Hoefnagel MHN; Quality Department, CBG-MEB (Medicines Evaluation Board), Utrecht, The Netherlands.
  • Stickings P; Medicines and Healthcare products Regulatory Agency, Hertfordshire, UK.
  • Smith D; Bacterial and combination vaccines division, Health Canada, Ontario, Canada.
  • Jungbäck C; International Association for Biological Standardization for Europe (IABS), Lyon, France.
  • Van Molle W; Quality of Vaccines and Blood Products, Sciensano, Brussels, Belgium.
  • Tesolin L; Quality of Vaccines and Blood Products, Sciensano, Brussels, Belgium.
Expert Rev Vaccines ; 22(1): 369-377, 2023.
Article in En | MEDLINE | ID: mdl-37010241
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Vaccines Language: En Journal: Expert Rev Vaccines Journal subject: ALERGIA E IMUNOLOGIA Year: 2023 Type: Article Affiliation country: Netherlands
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Vaccines Language: En Journal: Expert Rev Vaccines Journal subject: ALERGIA E IMUNOLOGIA Year: 2023 Type: Article Affiliation country: Netherlands