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21 results
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Strategies That Delay Market Entry of Generic Drugs.
Vokinger KN, Kesselheim AS, Avorn J, Sarpatwari A. Vokinger KN, et al. JAMA Intern Med. 2017 Nov 1;177(11):1665-1669. doi: 10.1001/jamainternmed.2017.4650. JAMA Intern Med. 2017. PMID: 28975217
Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs.
Hwang TJ, Jain N, Lauffenburger JC, Vokinger KN, Kesselheim AS. Hwang TJ, et al. Among authors: vokinger kn. JAMA Intern Med. 2019 Mar 1;179(3):374-380. doi: 10.1001/jamainternmed.2018.6417. JAMA Intern Med. 2019. PMID: 30640379 Free PMC article.
Evaluating New Rules on Transparency in Cancer Research and Drug Development.
Hwang TJ, Vokinger KN, Sachs RE. Hwang TJ, et al. Among authors: vokinger kn. JAMA Oncol. 2019 Apr 1;5(4):461-462. doi: 10.1001/jamaoncol.2018.7093. JAMA Oncol. 2019. PMID: 30789629 No abstract available.
Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs.
Vokinger KN, Kesselheim AS. Vokinger KN, et al. Health Policy. 2019 Aug;123(8):721-727. doi: 10.1016/j.healthpol.2019.06.002. Epub 2019 Jun 12. Health Policy. 2019. PMID: 31229275
Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine.
Hwang TJ, Kesselheim AS, Vokinger KN. Hwang TJ, et al. Among authors: vokinger kn. JAMA. 2019 Nov 22. doi: 10.1001/jama.2019.16842. Online ahead of print. JAMA. 2019. PMID: 31755907 No abstract available.
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.
Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Hwang TJ, et al. Among authors: vokinger kn. BMJ. 2020 Oct 7;371:m3434. doi: 10.1136/bmj.m3434. BMJ. 2020. PMID: 33028575 Free PMC article.
Opioid Crisis in the US - Lessons from Western Europe.
Vokinger KN. Vokinger KN. J Law Med Ethics. 2018 Mar;46(1):189-190. doi: 10.1177/1073110518766033. J Law Med Ethics. 2018. PMID: 31311413 No abstract available.
Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.
Vokinger KN, Kesselheim AS. Vokinger KN, et al. BMJ Open. 2019 Oct 10;9(10):e028634. doi: 10.1136/bmjopen-2018-028634. BMJ Open. 2019. PMID: 31601584 Free PMC article.
Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment.
Gyawali B, Hwang TJ, Vokinger KN, Booth CM, Amir E, Tibau A. Gyawali B, et al. Among authors: vokinger kn. Am Soc Clin Oncol Educ Book. 2019 Jan;39:374-387. doi: 10.1200/EDBK_242229. Epub 2019 May 17. Am Soc Clin Oncol Educ Book. 2019. PMID: 31099613
Access to Cancer Precision Medicines in Switzerland: A Comparative Analysis (USA and EU) and Health Policy Implications.
Vokinger KN, Muehlematter UJ, Rosemann TJ. Vokinger KN, et al. Public Health Genomics. 2018;21(5-6):238-243. doi: 10.1159/000501562. Epub 2019 Jul 18. Public Health Genomics. 2018. PMID: 31319411
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