table of contents
Chapter 1 General introduction 7
Chapter 2 The ability of animal studies to detect serious post marketing
adverse events is limited 17
Chapter 3 A retrospective evaluation of non-clinical studies predicting new
serious post marketing adverse events of biopharmaceuticals 29
Chapter 4 The value of non-human primates in the development
of monoclonal antibodies 39
Chapter 5 Immunogenicity of MABS in non-human primates during
non-clinical safety assessment 53
Chapter 6 Contribution of animal studies to evaluate the similarity
of biosimilars to reference products 67
Chapter 7 Measures of biosimilarity in monoclonal antibodies in oncology:
the case of Bevacizumab 83
Chapter 8 Discussion and perspectives 101
Chapter 9 Summary 119
Chapter 10 Nederlandse samenvatting 127
Appendix Glossary 137
List of co-authors 141
List of publications 143
Dankwoord 147
About the author 151