By Shayne Cox Gad
• 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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Extra info for Drug Safety Evaluation (Pharmaceutical Development Series)
Drug Safety Evaluation (Pharmaceutical Development Series) by Shayne Cox Gad