GPHA FALL TECHNICAL CONFERENCE NOV 2-5, 2015 BETHESDA, MD ICH

GPhA Fall Technical Conference Nov 2-5, 2015 Bethesda, MD ICH

  • Book type: PDF
  • Book size: n/a
  • Book Name: stephen-miller.pdf
  • Source: www.gphaonline.org

gpha fall technical conference nov 2-5, 2015 bethesda, md ich. 3 general principles •focus on dna-reactive impurities, i.e. mutagenic impurities typically positive in the bacterial mutagenicity assay •threshold of toxicological concern (ttc)
3 General Principles •Focus on DNA-reactive impurities, i.e. mutagenic impurities typically positive in the bacterial mutagenicity assay •Threshold of Toxicological Concern (TTC)

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