دورية أكاديمية
From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
| العنوان: | From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. |
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| المؤلفون: | Eichler HG; European Medicines Agency (EMA), London, UK., Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G |
| المصدر: | Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2015 Mar; Vol. 97 (3), pp. 234-46. Date of Electronic Publication: 2015 Feb 04. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2015- : Hoboken, NJ : Wiley Original Publication: St. Louis : C.V. Mosby |
| مواضيع طبية MeSH: | Licensure*, Drug Approval/*legislation & jurisprudence , Drug Approval/*methods , Drug Discovery/*legislation & jurisprudence, Humans |
| مستخلص: | The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients. (© 2015 American Society for Clinical Pharmacology and Therapeutics.) |
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| تواريخ الأحداث: | Date Created: 20150212 Date Completed: 20150416 Latest Revision: 20200225 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC6706805 |
| DOI: | 10.1002/cpt.59 |
| PMID: | 25669457 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1532-6535 |
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| DOI: | 10.1002/cpt.59 |