Literature DB >> 24422687

First-in-human trials with therapeutic proteins: regulatory rethink?

Christian K Schneider1.   

Abstract

Entities:  

Year:  2008        PMID： 24422687     DOI： 10.1586/17512433.1.3.327

Source DB:  PubMed          Journal:  Expert Rev Clin Pharmacol        ISSN： 1751-2433            Impact factor:   5.045


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  2 in total

1.  Next generation and biosimilar monoclonal antibodies: essential considerations towards regulatory acceptance in Europe. February 3-4, 2011, Freiburg, Germany.

Authors:  Janice M Reichert
Journal:  MAbs       Date:  2011-05-01       Impact factor: 5.857

2.  First-in-human clinical trials with vaccines--what regulators want.

Authors:  Karen B Goetz; Michael Pfleiderer; Christian K Schneider
Journal:  Nat Biotechnol       Date:  2010-09       Impact factor: 54.908
  2 in total

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