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Issue 6, 2018

Posted: 17 December 2018 | | No comments yet

In this issue: Navigating roadblocks to clinical success: decision-making from molecule to clinic, Raman spectroscopy for the qualitative analysis of falsified and substandard medicines, and an overview of risk assessments for elemental impurities: implementation of ICH Q3D guidelines.

Issue 6 2018 magazine

In this issue:

  • FOREWORD: Brexit and balance
    Dave Elder, JPAG member and David P Elder Consultancy
  • BIOPHARMA, PROCESSING & DEVELOPMENT: The data challenges of R&D and collaboration
    Unjulie Bhanot, Solutions Consultant at IDBS
  • REGULATORY INSIGHT: Clinically relevant dissolution specifications: selection and assessment using in vitro data
    Juliet Symonds, Chun-Hang Tang and Kevin Lief, GlaxoSmithKline
  • EXPERT VIEW: What ADC evolution means for manufacturing
    Jyothi Swamy and Lisa McDermott, Merck KGaA
  • FORMULATION, DEVELOPMENT & DELIVERY: Real-time PCR detection of Staphylococcus aureus in pharmaceutical products contaminated with mixed bacterial cultures
    Luis Jimenez, Arianna Pinto, Stephanie Perez, Sibora Peca, and Lisa Pincus Biology and Horticulture Department, Bergen Community College, Paramus, New Jersey
  • FREEZE DRYING: The obstacle to developing an optimum placebo formulation for pharmaceutical freeze drying
    Henning Gieseler and Julia Kosan, GILYOS GmbH
  • RAMAN: Recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines
    Laureen Coic, Pierre-Yves Sacre, Hermane Avohou, Riccardo Deidda, Charlotte De Bleye, Elodie Dumont, Roland Marini, Philippe Hubert and Eric Ziemons, University of Liege, Belgium

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