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  • This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics:

    Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development;
    Explains scientific and philosophical bases for evaluation of specific concerns - including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity;
    Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars;
    Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation;
    Adds almost 20% new and thoroughly updates existing content from the last edition. 895 p.




Authors expertises affiliations

  • Shayne Cox Gad, B.S. Chemistry and Biology, Ph.D. in Pharmacology/Toxicology. Gad Consulting Services, Raleigh, NC (USA).
  • Publisher : Wiley-Blackwell
  • Publication date (print) : 2016-12
  • ISBN (print) : 978-1-119-09739-6
  • ISBN (ebook) : 978-1-119-09741-9

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