Drug Safety Evaluation, 3rd Edition
Wiley | English | December 2016 | ISBN-10: 1119097398| 920 pages | PDF | 8.37 mb
by Shayne Cox Gad (Author)DescriptionThis practical guide presents a road map for safety assessmentas an integral part of the development of new drugs and therapeutics.Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and earlyclinical drug developmentExplains scientific andphilosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicityCovers the development of new small and large molecules, generics, 505(b)(2) route NDAs,and biosimilarsRevises material to reflect new drug products (small synthetic, large proteins and cells, andtissues), harmonized global and national regulations, and new technologies for safety evaluationAdds almost 20% newand thoroughly updates existing content from the last edition
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