Following FDA approval and marketing, drug companies may conduct further studies on their products. These post-approval studies have several objectives, including comparing the drug with other drugs already in the market, monitoring the drug's long-term effectiveness, and determining additional potential uses for the drug.
Glossary
Phase IV
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Ampoule (Ampule)
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HME
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Validation
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APIs
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Toxicology
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GDUFA
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Inspections
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Capsules
Microcapsule
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Wurster Process
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