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PubMed

The road to market implantable drug delivery systems: a review on US FDA's regulatory framework and quality control requirements.

PMID: 30084277 ·

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RevistaPharmaceutical development and technology
Ano
PMID30084277

Resumo

The scope of Implantable Drug Delivery Systems (IDDSs) comprehends a variety of sterile therapeutic implements placed inside the body to exert a certain therapeutic action for extended duration. They are classified under different categories from pharmaceutical science and regulatory perspectives. The novelty and variety of IDDSs prevent the application of a uniform regulation for all IDDS products; therefore, sponsors face regulatory challenges to register and market their products. This review

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