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• W2552775081 startingPage "7" @default.
• W2552775081 abstract "Abstract The development of a new drug is a complicated, long, and expensive process and confronts the experts in all disciplines involved with unexpected challenges during the complex process it takes to bring new medicines to the market. Historical examples are presented from medicines during different phases of drug development highlighting general or specific issues, which, in turn, may have led either to modifications of general requirements for the nonclinical characterization of new investigational drugs or to modifications of the requirements for risk management and mitigation in humans or to a combination of both. TGN1412 is used as an example demonstrating that life-threatening toxicities can be induced in humans with a biopharmaceutical if the nonclinical studies are not conducted using a pharmacological active species. Positive genotoxicity or carcinogenicity studies do not necessary indicate the end of the road for a new compound. With the detailed understanding of certain toxicities new disciplines and testing strategies developed (eg, reproductive toxicology testing following the thalidomide tragedy, cardiac safety pharmacology testing following identification of QT prolongation as cause of fatal arrhythmias). Nonclinical toxicology studies have been proven to be predictive for side effects in human and are used to guide monitoring in patients. However, there are still areas where toxicities occur unexpectedly in patients (eg, idiosyncratic liver injury, cardiotoxicity). Despite all efforts to predict possible side effects in humans based on nonclinical experiments the complete safety profile of a new prescription drug will only become evident once larger patient populations are exposed under marketing conditions. Rare events (1 in 100,000) are usually not discovered during clinical development and have resulted in drug withdrawals from the market. During all stages, from the identification of a target over the nonclinical and clinical testing through the postmarketing, potential obstacles are numerous and the unexpected has to be expected at each step on the way." @default.
• W2552775081 created "2016-11-30" @default.
• W2552775081 creator A5000825416 @default.
• W2552775081 creator A5003947485 @default.
• W2552775081 date "2017-01-01" @default.
• W2552775081 modified "2023-09-26" @default.
• W2552775081 title "Critical Aspects of Integrated Nonclinical Drug Development" @default.
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