European Pharmaceutical Review Issue 3 2019
In this issue we explore reasons behind critical key drug shortages in the EU, whether viability methods effectively detect all viable organisms and how companies can future-proof their digital technologies ahead of Brexit. Also included are articles on higher order protein structure, FMD compliance and Raman spectroscopy.
Included in this issue:
- REGULATORY INSIGHT
Tadalafil UKSC decision: evolution of the multi-factorial approach
Dr Matthew Royle and Taylor Wessing
Brexit-tech: overcoming post-brexit challenges by driving operational and cost efficiencies
Neal Singh, Icertis
- BIOPROCESSING & BIOPRODUCTION
Analytical methods used in obtaining higher order structure information from protein therapeutics
Ioannis A. Papayannopoulos and Shannon Renn-Bingham, Celldex Therapeutics, Inc.
- FORMULATION, DEVELOPMENT & DELIVERY
Capsosomes: the revolutionary enzyme carriers
Marc Baiget Francesch
- QA/QC AND ANALTICAL TECHNIQUES
Do viability methods detect all viable organisms?
Jeanne Moldenhauer, Excellent Pharma Consulting, Inc
- MANUFACTURING, PACKAGING & LOGISTICS
Manufacturing medical devices to ISO 13485:2016
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