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After successful preclinical trials, the API enters clinical development, where it is tested in a series of progressively larger phases in human subjects. Each phase is designed to gather more data about the drug's safety and effectiveness. Depending on the results of these studies, the drug may eventually receive approval from regulatory bodies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), paving the way for commercial production.
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Quality control includes conducting comprehensive testing for identity, potency, purity, and microbial contamination
. Manufacturers must also maintain detailed records of production processes, process deviations, and corrective actions, ensuring that any issues can be tracked and resolved swiftly....