期刊
JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY
卷 30, 期 1, 页码 1-13出版社
MARY ANN LIEBERT, INC
DOI: 10.1089/jamp.2016.1326
关键词
apps; device; DPI; generic inhaler; human factors; instructions for use; MDI; patient; regulatory; smart technology; telehealth
资金
- ISAM
- IPAC-RS
This article reports on discussions at the 2015 workshop cosponsored by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) and the International Society for Aerosols in Medicine (ISAM), entitled Regulatory and Patient Considerations for Inhalation Device Design, Development and Use. Key topics addressed at the workshop and presented here include patient-focused device design for orally inhaled products (OIPs), instructions for use (IFU), human factors, regulatory considerations in the United States and Europe, development of generic inhalers, quality-by-design, and change management of OIP devices. Workshop participants also identified several areas for further consideration and emphasized the need for increased focus on the patient to create therapeutic products (inclusive of device design, IFU, education, training) that support adherence with an individual patient's treatment regimen. Advances in patient-centric product development will require engagement and collaboration by industry, regulators, patients, physicians, and other stakeholders. The article includes summaries of presented talks as well as of panel and audience discussions.
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