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The clinical evaluation of a drug in human beings is a critical component of drug development and regulatory affairs, designed to ensure the safety, efficacy, and quality of a pharmaceutical product before it reaches the market. This evaluation is structured in a series of phases, each with specific objectives, methodologies, and regulatory requirements. Clinical trials in humans are generally divided into four main phases: Phase I, Phase II, Phase III, and Phase IV. Phase I trials are the first stage of testing a new drug in human subjects, typically involving a small group of healthy volunteers, usually between 20 to 100 participants. The primary objective of Phase I is to assess the safety profile of the drug, including tolerability, pharmacokinetics (absorption, distribution, metabolism, and excretion), and pharmacodynamics (the drug's effects on the ______ ____ __________ _______ ____ _____ _____ ___ _________.
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