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Issue #4 2016 – Digital edition

24 August 2016  •  Author(s): European Pharmaceutical Review

In the digital version of Issue #4 2016:

  • European Pharmaceutical Review Issue #4 2016FOREWORD: EPR health-based exposure limits for cleaning qualification
    David P. Elder, JPAG chair and Consultant
  • REGULATORY INSIGHT: The legal framework applicable to biosimilars in the EU
    Hilary Jones, Bristows LLP
  • ENVIRONMENTAL MONITORING: IN-DEPTH FOCUS
    With articles from R. Vijayakumar, Majmaah University, Tim Sandle, Bio Products Laboratory and Anastasia Petropoulou, University Hospital Bristol’s NHS Foundation Trust
  • DRUG DELIVERY: Approaches in subcutaneous delivery of monoclonal antibodies
    Claus Geiger, Till Bussemer, Tanya Mezhebovsky and Bernardo Perez-Ramirez, Sanofi
  • MICROBIOLOGY SERIES: Current activities of the USP general chapters
    Radhakrishna Tirumalai, PhD, United States Pharmacopeial Convention
  • TRACK AND TRACE
    Including legal analysis from Kathleen M. Sanzo and Jacqueline Berman, Morgan, Lewis & Bockius LLP, and Jacob Gifford Head, Thomas More Chambers
  • SPECTROSCOPY: IN-DEPTH FOCUS
    With contributions from Koen De Smet, Tom Van Den Kerkhof and Anke Prudic, Janssen, and Daniel Markl, Michael T. Ruggiero, and J. Axel Zeitler, University of Cambridge
  • HPLC: Application of LCMS in small-molecule drug development
    Chunang (Christine) Gu, David Russell and Peter Yehl, Genentech
  • MASS SPECTROMETRY: Characterising therapeutic antibodies and ADCs using mass spectrometry
    Ioannis Papayannopoulos, Celldex Therapeutics

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