Question

Give the main objectives of phase I and II of Clinical Trial.

06 Mar 2018
Answer :
Word Count : 334

Phase I and Phase II clinical trials are critical stages in the drug development process, focused on evaluating the safety and efficacy of experimental drugs. These trials serve distinct objectives:

Phase I Clinical Trials:

1. Safety Assessment: The primary goal of Phase I trials is to assess the safety of the investigational drug. Researchers determine the maximum tolerated dose (MTD) and observe any adverse effects. This phase typically involves a small number of healthy volunteers.

2. Pharmacokinetics: Phase I studies investigate how the drug is absorbed, distributed, metabolized, and excreted in the human body (pharmacokinetics). This information helps in determining dosing regimens for subsequent phases.

3. Preliminary Efficacy: Although not the main objective, Phase I trials may provide initial insights

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