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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
    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
    Including legal analysis from Kathleen M. Sanzo and Jacqueline Berman, Morgan, Lewis & Bockius LLP, and Jacob Gifford Head, Thomas More Chambers
    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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