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Design and Analysis of a Biosimilar Bridging Study with a Prediction Interval-Based Consistency Test.
Pan, Zhiying; Huang, Wenying; Pan, Jianhong; Koch, Gary.
Affiliation
  • Pan Z; Amgen Inc, 1 Amgen Center Dr, Thousand Oaks, CA, 91320, USA. jpan@amgen.com.
  • Huang W; FlashSync Corporation, San Diego, CA, USA.
  • Pan J; Office of Biostatistics and Clinical Pharmacology, Center for Drug Evaluation, NMPA, Beijing, China.
  • Koch G; Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
Ther Innov Regul Sci ; 55(4): 765-772, 2021 07.
Article in En | MEDLINE | ID: mdl-33797059
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biosimilar Pharmaceuticals Type of study: Guideline / Prognostic_studies / Risk_factors_studies Language: En Journal: Ther Innov Regul Sci Year: 2021 Document type: Article Affiliation country: Country of publication:
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biosimilar Pharmaceuticals Type of study: Guideline / Prognostic_studies / Risk_factors_studies Language: En Journal: Ther Innov Regul Sci Year: 2021 Document type: Article Affiliation country: Country of publication: