Initial Clinical Studies

Usually, the initial clinical goals are to study toler-ability and to provide initial pharmacokinetic assessments. These studies may only involve single doses of the drug administered to normal volunteers. Such a clinical study would require a restricted set of toxicity studies to support the safe use of the drug in this situation. On the other hand, some companies achieve economies by having the initial toxicology program be sufficient to support not only initial clinical studies but also Phase II. The toxicology studies may then involve repeated doses over a period of weeks. Thus, the initial clinical studies must be determined before the non-clinical program can be designed.

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