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Synopsis

  • Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical
  • Contains the most pertinent international regulatory guidance documents for nonclinical evaluation
  • Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars"
  • A multi-authored book with chapters written by qualified experts in their respective fields

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