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Pharmaceuticals / Quality

FDA Releases Guidance on Quality Considerations for Inhaled Drugs

April 23, 2018

The FDA published draft guidance on metered dose and dry powder inhalers highlighting considerations for critical quality attributes.

Sponsors should create a desired quality target product profile (QTPP) before development begins, the agency said, including elements such as strength, purity and stability, aerodynamic performance and the proposed dosage form and delivery system.

Early in the development process, applicants also should develop a list of potential critical quality attributes (CQAs) within appropriate limits, with each CQA relating to one or more elements of the QTPP. The list can be changed as the development progresses.

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