From Animal Experiments to Clinical Dosing: Some Aspects of Preclinical Development of Antidepressants
In the preclinical evaluation of new drugs several questions must be answered before a drug can be released for administration to humans. Obviously, the first question is always: Does the drug possess the desired pharmacological activity at all? If such activity is identified, there are other important questions which may be answered only in more elaborate studies. During the various phases of preclinical evaluation of a new drug (Table 1) the potency and dose dependency of effects, general and specific toxicity, its relationship to the desired activity, and additional pharmacological effects and their relation to the main effect must be established. The findings generated in each phase of preclinical studies determined the decision as to further development of the drug for a particular indication. In other words, the pharmacological objectives of drug research in animals consist of the evaluation of the profile and mechanism of action and thus the prediction of the therapeutic properties, efficacy and side effect profile of a drug.
KeywordsSide Effect Profile Preclinical Evaluation Noradrenaline Uptake Behavioural Despair Antidepressant Potential
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