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Drug Safety Evaluation, Third Edition (Hardcover, 3rd Edition)
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Drug Safety Evaluation, Third Edition (Hardcover, 3rd Edition)
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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
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