David J. Snodin, Ph.D.

Xiphora Biopharma Consulting

Articles by David J. Snodin, Ph.D.

  • Genotoxic/Mutagenic Impurities Part 3: CMC (Chemistry, Manufacturing and Controls) Overview

    Tuesday, May 21, 2013
    This third article in a series on genotoxic/mutagenic impurities (GTIs) will discuss the challenges facing synthetic and analytical chemists as they endeavor to identify and ultimately control levels of these GTIs or PGIs (potentially genotoxic ...
  • Genotoxic Impurities Part 2: Toxicological Overview

    Sunday, September 16, 2012
    This second article on genotoxic / mutagenic impurities (GTIs) will focus on toxicological aspects and discuss in more detail some of the themes mentioned in the first part of the series [1]. The current [2,3] and evolving guidance [4] is based on a ...
  • Genotoxic Impurities Part 1: General Overview

    Friday, May 25, 2012
    This series of articles is intended to provide a general overview of the issues surrounding genotoxic impurities (GTIs) and their potential resolution. Part 1 will focus on general and regulatory aspects, part 2 will review toxicological issues, ...
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