By Shayne Cox Gad

This useful consultant offers a street map for security evaluate as a vital part of the improvement of recent medicinal drugs and therapeutics.

•    Helps readers remedy medical, technical, and regulatory concerns in preclinical protection review and early scientific drug development
•    Explains medical and philosophical bases for assessment of particular issues – together with neighborhood tissue tolerance, aim organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity
•    Covers the advance of recent small and massive molecules, generics, 505(b)(2) course NDAs, and biosimilars
•    Revises fabric to mirror new drug items (small man made, huge proteins and cells, and tissues), harmonized worldwide and nationwide laws, and new applied sciences for protection evaluation
•    Adds virtually 20% new and punctiliously updates current content material from the final edition

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Drug Safety Evaluation (Pharmaceutical Development Series) by Shayne Cox Gad


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