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Factors related to drug approvals: predictors of outcome?

Liberti L, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H. Liberti L, et al. Among authors: mcauslane n. Drug Discov Today. 2017 Jun;22(6):937-946. doi: 10.1016/j.drudis.2017.03.003. Epub 2017 Mar 10. Drug Discov Today. 2017. PMID: 28288783 Review.

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Benchmarking health technology assessment agencies-methodological challenges and recommendations.

Wang T, Lipska I, McAuslane N, Liberti L, Hövels A, Leufkens H. Wang T, et al. Among authors: mcauslane n. Int J Technol Assess Health Care. 2020 Sep 8:1-17. doi: 10.1017/S0266462320000598. Online ahead of print. Int J Technol Assess Health Care. 2020. PMID: 32895091

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Adaptive licensing and facilitated regulatory pathways: A survey of stakeholder perceptions.

Liberti L, Stolk P, McAuslane N, Somauroo A, Breckenridge AM, Leufkens HG. Liberti L, et al. Among authors: mcauslane n. Clin Pharmacol Ther. 2015 Nov;98(5):477-9. doi: 10.1002/cpt.140. Epub 2015 Jun 30. Clin Pharmacol Ther. 2015. PMID: 25877216 Review. No abstract available.

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The Confluence of Accelerated Regulatory and Health Technology Assessment Access Pathways.

McAuslane N, Liberti L, Connelly P. McAuslane N, et al. Clin Pharmacol Ther. 2019 Apr;105(4):935-942. doi: 10.1002/cpt.1315. Epub 2019 Jan 16. Clin Pharmacol Ther. 2019. PMID: 30472729 Review.

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A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013-2016.

Patel P, Cerqueira DM, Santos GML, de Lima Soares R, Sousa VD, Liberti L, McAuslane N. Patel P, et al. Among authors: mcauslane n. Ther Innov Regul Sci. 2020 Nov;54(6):1428-1435. doi: 10.1007/s43441-020-00169-5. Epub 2020 Jun 9. Ther Innov Regul Sci. 2020. PMID: 32519282 Free PMC article.

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Does conditional approval for new oncology drugs in Europe lead to differences in health technology assessment decisions?

Lipska I, Hoekman J, McAuslane N, Leufkens HG, Hövels AM. Lipska I, et al. Among authors: mcauslane n. Clin Pharmacol Ther. 2015 Nov;98(5):489-91. doi: 10.1002/cpt.198. Epub 2015 Sep 8. Clin Pharmacol Ther. 2015. PMID: 26250656 Review.

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A DECADE OF HEALTH TECHNOLOGY ASSESSMENT IN POLAND.

Lipska I, McAuslane N, Leufkens H, Hövels A. Lipska I, et al. Among authors: mcauslane n. Int J Technol Assess Health Care. 2017 Jan;33(3):350-357. doi: 10.1017/S0266462317000563. Epub 2017 Jul 19. Int J Technol Assess Health Care. 2017. PMID: 28720170

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The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions.

Bujar M, McAuslane N, Liberti L. Bujar M, et al. Among authors: mcauslane n. Pharmaceut Med. 2021 Mar;35(2):113-122. doi: 10.1007/s40290-020-00372-7. Epub 2021 Feb 4. Pharmaceut Med. 2021. PMID: 33537899 Free PMC article.

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A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways.

Liberti L, McAuslane N, Stolk P, Breckenridge A, Leufkens H. Liberti L, et al. Among authors: mcauslane n. Ther Innov Regul Sci. 2020 Jan;54(1):55-68. doi: 10.1007/s43441-019-00029-x. Epub 2020 Jan 6. Ther Innov Regul Sci. 2020. PMID: 32008253

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Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice.

Rodier C, Bujar M, McAuslane N, Patel P, Liberti L. Rodier C, et al. Among authors: mcauslane n. Ther Innov Regul Sci. 2021 Jan;55(1):118-128. doi: 10.1007/s43441-020-00196-2. Epub 2020 Jul 2. Ther Innov Regul Sci. 2021. PMID: 32617911 Free PMC article.

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