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Title:           Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
Subject:         BioDrugs, https://doi.org/10.1007/s40259-023-00631-4
Author:          Nadine Kirsch-Stefan 
Creator:         Springer
CreationDate:    Wed Oct 11 13:24:41 2023 CEST
ModDate:         Fri Oct 13 15:13:30 2023 CEST
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     Item: 
      Title: Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
      Children: 
       Item: 
        Title: Abstract
        Children: 
         Item: 
          Title: Background 
         Item: 
          Title: Objective 
         Item: 
          Title: Methods 
         Item: 
          Title: Results 
         Item: 
          Title: Conclusion 
       Item: 
        Title: 1 Introduction
       Item: 
        Title: 2 Methods
        Children: 
         Item: 
          Title: 2.1 Analysis of MAA Outcome
         Item: 
          Title: 2.2 Analysis of First Regulatory Assessment Reports
         Item: 
          Title: 2.3 Evaluation of Analytical and Clinical Biosimilarity for Rituximab and Trastuzumab Biosimilars
       Item: 
        Title: 3 Results
        Children: 
         Item: 
          Title: 3.1 MAA Evidence and Results
         Item: 
          Title: 3.2 Analysis of First Regulatory Assessment Reports
         Item: 
          Title: 3.3 Evaluation of Analytical Biosimilarity and Clinical Comparability for Rituximab and Trastuzumab Biosimilars
          Children: 
           Item: 
            Title: 3.3.1 Comparison of Analytical Biosimilarity Across Products
           Item: 
            Title: 3.3.2 Comparison of Analytical Biosimilarity for Withdrawn Products
         Item: 
          Title: 3.4 Results of Clinical Comparability Studies
          Children: 
           Item: 
            Title: 3.4.1 PK Studies
            Children: 
             Item: 
              Title: 3.4.1.1 Rituximab 
             Item: 
              Title: 3.4.1.2 Trastuzumab 
             Item: 
              Title: 3.4.1.3 Population PK 
           Item: 
            Title: 3.4.2 Clinical Efficacy Studies
            Children: 
             Item: 
              Title: 3.4.2.1 Rituximab 
             Item: 
              Title: 3.4.2.2 Trastuzumab 
             Item: 
              Title: 3.4.2.3 Safety and Immunogenicity 
       Item: 
        Title: 4 Discussion
        Children: 
         Item: 
          Title: 4.1 Discussion of MAA Evidence and Results
         Item: 
          Title: 4.2 Discussion of Analysis of First Regulatory Assessment Reports
         Item: 
          Title: 4.3 Discussion of Analysis of Analytical Biosimilarity for Rituximab and Trastuzumab Biosimilars
         Item: 
          Title: 4.4 Discussion of Analysis of Clinical Comparability for Rituximab and Trastuzumab Biosimilars Including Withdrawn Biosimilar Candidates
         Item: 
          Title: 4.5 General Discussion on Current Flexibility in Clinical Trial Requirements
         Item: 
          Title: 4.6 Limitation of the Study
       Item: 
        Title: 5 Conclusions of Our Study
       Item: 
        Title: Anchor 36
       Item: 
        Title: Acknowledgements 
       Item: 
        Title: References
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    Title: Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
    Author: Nadine Kirsch-Stefan 
    Subject: BioDrugs, https://doi.org/10.1007/s40259-023-00631-4
    Creator: Springer
    CreationDate: Wed Oct 11 13:54:41 CEST 2023
    ModDate: Fri Oct 13 15:43:30 CEST 2023
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