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Once an API is developed, it undergoes rigorous testing to ensure its safety and efficacy. This includes preclinical studies, often conducted in vitro (in test tubes) and in vivo (in live organisms), followed by multiple phases of clinical trials with human subjects. Each phase aims to assess different aspects, such as dosage safety, effectiveness, and adverse effects. This stringency is crucial, as even small changes in the API's chemistry can significantly affect the drug's performance and safety profile.


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The regulatory bodies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), play a crucial role in this process. They evaluate the data submitted by pharmaceutical companies, including the formulation, manufacturing process, and clinical trial outcomes. This thorough review ensures that only safe and effective medications reach the market.


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