Clinical experimentation occurs in four stages. The determination of the human dosage range based on responses in healthy subjects is a goal of phase _____ of human clinical experimentation.

Question

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Phase I trials are primarily designed to assess safety. The objectives of phase I are to determine the human dosage range based on response in healthy human subjects and to identify the pharmacokinetics (i.e., absorption, distribution, metabolism/biotransformation, excretion/elimination) of the drug. Progression to the next phase occurs if no serious adverse effects are demonstrated, the drug is eliminated in a reasonable amount of time, and the dose range is below that known to induce pathology in animals.

Clinical Experimentation Occurs in Four Stages