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• W1566932442 abstract "Drug development is a complex process that includes drug discovery/product development, pre-clinical research (in vitro/in vivo) and clinical trials. The new chemical entities, which show promising pharmacodynamic activity in in vitro experiments on particular biological targets, thought to play critical pathophysiological roles in specific diseases, emerge from the process of drug discovery and are candidates to undergo safety and toxicity tests, as well as pharmacokinetic and metabolism evaluations in in vivo preclinical models. Moreover, pre-clinical investigations are focused on determining the dose and administration schedule to be used in the first human clinical trial (first-in-man or first human dosing). Clinical drug development is currently arranged into four phases, with phase I traditionally representing the very early stage of drug development in humans. Phase I is conducted to establish safety and tolerability, to evaluate pharmacokinetics and to obtain preliminary data on pharmacodynamics. Phase I begins with the first administration of a new compound in humans (Pocock, 1983). Based on differences in the experimental design, various types of phase I trials can be distinguished: (1) Single ascending dose studies, in which small groups of subjects receive a single dose of the test drug, afterward they are observed and examined for a given period of time. If subjects do not experience any remarkable adverse effect, and pharmacokinetic data are roughly consistent with pre-specified safety values, the dose is escalated up, and a new group of subjects is then given a higher dose (Buoen et al., 2005). This stepping-up dose is continued until the pre-calculated pharmacokinetic safety levels are achieved, or intolerable side effects occur, indicating the point at which the drug appears to have reached the maximum tolerated dose (Friedman et al., 1996). The first dose to be tested in phase I is estimated as a fraction of the so called “no adverse effect dose”, which is the highest dose found not to harm animals under appropriate toxicity/safety testing. (2) Multiple ascending dose studies, characterized by an experimental design similar to single ascending dose studies, with the exception that, at each step, a small group of subjects undergoes repeated administration of the same dose of the test drug. Such studies can be conducted to better understand the pharmacokinetics and pharmacodynamics of the new drug at the steady state. (3) Short trials, designed to investigate variations in the absorption of the new drug following its oral administration in the presence of food." @default.
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• W1566932442 date "2011-12-07" @default.
• W1566932442 modified "2023-10-16" @default.
• W1566932442 title "Drug Experimentation in Healthy Volunteers" @default.
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• W1566932442 doi "https://doi.org/10.5772/27919" @default.
• W1566932442 hasPublicationYear "2011" @default.
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