منابع مشابه
Compassionate use of cell products
Investigational medicinal products are available to patients through two pathways. The first is by participating in a clinical trial, the second as part of a compassionate use program, which is the use of an investigational medicinal product outside a clinical trial in patients with serious or life-threatening diseases for which no other treatment is available or expected to be effective. Usual...
متن کاملEthics review in compassionate use
BACKGROUND Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use basis may be performed in Japan and China. However, there are important differences between relevant regulations in individual countries, particula...
متن کاملCompassionate use of orphan drugs
BACKGROUND EU regulation 726/2004 authorises manufacturers to provide drugs to patients on a temporary basis when marketing authorisation sought centrally for the entire EU is still pending. Individual Member States retain the right to approve and implement such 'compassionate use' programmes which companies will usually provide for free. Nevertheless some companies have opted not to partake in...
متن کاملCompassionate use programs in Italy: ethical guidelines
BACKGROUND This article proposes a retrospective analysis of a compassionate use (CU), using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee (EC) following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific e...
متن کاملEverolimus for Compassionate Use in Multiple Basal Cell Carcinomas
Everolimus is an inhibitor of the mammalian target of rapamycin (mTOR) and has been shown to have antineoplastic activity in addition to its use as an immunosuppressive agent for the prevention of organ transplant rejection. We report the use of everolimus for the compassionate treatment of four elderly, nontransplant patients presenting with multiple basal cell carcinomas (BCC). All patients h...
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ژورنال
عنوان ژورنال: Journal of Vascular Nursing
سال: 2020
ISSN: 1062-0303
DOI: 10.1016/j.jvn.2020.11.001