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  • John Reichard, Martin A. Maier, +6 authors Patricia A Weideman
  • Medicine
  • Regulatory toxicology and pharmacology : RTP
  • 2016 (First Publication: 15 August 2016)
  • The purpose of this paper is to describe the use of toxicokinetic (TK) and toxicodynamic (TD) data in setting acceptable daily exposure (ADE) values and occupational exposure limits (OELs). Use of TKExpand
  • Edward V. Sargent, Andreas Flueckiger, +4 authors Patricia A Weideman
  • Medicine
  • Regulatory toxicology and pharmacology : RTP
  • 2016 (First Publication: 15 August 2016)
  • Cross-contamination in multi-product pharmaceutical manufacturing facilities can impact both product safety and quality. This issue has been recognized by regulators and industry for some time,Expand
  • Eileen Hayes, Robert A. Jolly, +10 authors Patricia A Weideman
  • Medicine
  • Regulatory toxicology and pharmacology : RTP
  • 2016 (First Publication: 15 August 2016)
  • A European Union (EU) regulatory guideline came into effect for all new pharmaceutical products on June 1st, 2015, and for all existing pharmaceutical products on December 1st, 2015. This guidelineExpand
  • Lynne T Haber, Reena Sandhu, Angela Li-Muller, Asish Mohapatra, Sanya Petrovic, M. E. Bette Meek
  • Medicine, Chemistry
  • Journal of applied toxicology : JAT
  • 2016 (First Publication: 1 September 2016)
  • Durations of exposure to chemicals, whether for single, repeated or intermittent periods, may vary from those upon which most guidance values are normally based. Because it is presently not feasibleExpand