A dosage form that is a solid or semisolid material containing the API that is inserted into the body. The insertion process is invasive, and the material is intended to reside at the site for a period consistent with the design release kinetics or profile of the API(s).
Glossary
Implant
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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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