E-viri
Recenzirano
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Serrano, Philippe; Hartmann, Markus; Schmitt, Elmar; Franco, Pedro; Amexis, Georgios; Gross, Jan; Mayer‐Nicolai, Christine
Clinical pharmacology and therapeutics, March 2019, 2019-03-00, 20190301, Letnik: 105, Številka: 3Journal Article
Immune checkpoint inhibitors (ICI) have demonstrated meaningful patterns of clinical efficacy across various cancers. During their development, novel regulatory strategies and clinical design approaches were explored. This metrics‐based narrative review examines submission strategies and clinical evidence expectations of the US, European, and Japanese drug agencies, as well as their impact on approval and overall development times. Also discussed is the role of emerging clinical science and biomarker evaluation to get the first six ICI initially approved.
