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Direct-to-Consumer Genetic Testing: A Comprehensive Review. Ther Innov Regul Sci. 2023 Nov; 57(6):1190-1198.
Jiang S, Liberti L, Lebo D. PMID: 37589855.
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3 Fields:
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A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways. Ther Innov Regul Sci. 2023 11; 57(6):1260-1268.
Adams I, Cuff PA, Liberti L. PMID: 37552399; PMCID: PMC10579112.
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PubMed Mentions: Fields:
Translation:
HumansPHPublic Health
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Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America. Rev Panam Salud Publica. 2022; 46:e115.
van der Zee IT, Vreman RA, Liberti L, Garza MA. PMID: 36060200; PMCID: PMC9426952.
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Cooperation Agreements, Memorandums of Understanding, and Letters of Intent as Instruments to Facilitate the Implementation of Reliance in Latin America. Clin Ther. 2022 08; 44(8):1107-1128.
Rodríguez H, De Lucia ML, Liberti L. PMID: 35798570.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports? Clin Ther. 2021 05; 43(5):888-905.
Bujar M, Ferragu S, McAuslane N, Liberti L, Kühler TC. PMID: 33883070.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions. Pharmaceut Med. 2021 03; 35(2):113-122.
Bujar M, McAuslane N, Liberti L. PMID: 33537899; PMCID: PMC7858039.
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PubMed Mentions:
4
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Companies' Health Technology Assessment Strategies and Practices in Australia, Canada, England, France, Germany, Italy and Spain: An Industry Metrics Study. Front Pharmacol. 2020; 11:594549.
Wang T, McAuslane N, Liberti L, Gardarsdottir H, Goettsch W, Leufkens H. PMID: 33390978; PMCID: PMC7775670.
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PubMed Mentions:
9
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An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017-2018 using the OpERA methodology. J Pharm Policy Pract. 2020; 13:56.
Liberti L, Extavour RM, Patel P, McAuslane N. PMID: 32939288; PMCID: PMC7487479.
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PubMed Mentions:
2
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Benchmarking health technology assessment agencies-methodological challenges and recommendations. Int J Technol Assess Health Care. 2020 Sep 08; 1-17.
Wang T, Lipska I, McAuslane N, Liberti L, Hövels A, Leufkens H. PMID: 32895091.
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Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative. PLoS Med. 2020 08; 17(8):e1003092.
Giaquinto AR, Grignolo A, Liberti L, Lim JCW, Salmonson T, Sauer F, Ukwu H. PMID: 32785224; PMCID: PMC7423065.
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PubMed Mentions:
5 Fields:
Translation:
Humans
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Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice. Ther Innov Regul Sci. 2021 01; 55(1):118-128.
Rodier C, Bujar M, McAuslane N, Patel P, Liberti L. PMID: 32617911; PMCID: PMC7785566.
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PubMed Mentions:
4 Fields:
Translation:
Humans
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A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013-2016. Ther Innov Regul Sci. 2020 11; 54(6):1428-1435.
Patel P, Cerqueira DM, Santos GML, de Lima Soares R, Sousa VD, Liberti L, McAuslane N. PMID: 32519282; PMCID: PMC7704494.
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PubMed Mentions:
8 Fields:
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A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways. Ther Innov Regul Sci. 2020 01; 54(1):55-68.
Liberti L, McAuslane N, Stolk P, Breckenridge A, Leufkens H. PMID: 32008253.
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PubMed Mentions:
4 Fields:
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To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016. BMJ Open. 2019 11 25; 9(11):e028677.
Kühler TC, Bujar M, McAuslane N, Liberti L. PMID: 31772082; PMCID: PMC6887045.
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PubMed Mentions:
5 Fields:
Translation:
Humans
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The Confluence of Accelerated Regulatory and Health Technology Assessment Access Pathways. Clin Pharmacol Ther. 2019 04; 105(4):935-942.
McAuslane N, Liberti L, Connelly P. PMID: 30472729.
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PubMed Mentions:
6 Fields:
Translation:
Humans
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Accelerated approval of medicines: fit for purpose? Nat Rev Drug Discov. 2018 06; 17(6):379-380.
Breckenridge A, Liberti L. PMID: 29302066.
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PubMed Mentions:
3 Fields:
Translation:
Humans
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Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions. Value Health. 2018 06; 21(6):707-714.
Wang T, McAuslane N, Liberti L, Leufkens H, Hövels A. PMID: 29909876.
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PubMed Mentions:
17 Fields:
Translation:
Humans
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A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment? Front Pharmacol. 2017; 8:384.
Allen N, Liberti L, Walker SR, Salek S. PMID: 28713265; PMCID: PMC5491965.
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PubMed Mentions:
21
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FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines. Front Pharmacol. 2017; 8:161.
Liberti L, Bujar M, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H. PMID: 28420989; PMCID: PMC5376616.
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PubMed Mentions:
12
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The Benefit-Risk Assessment of Medicines: Experience of a Consortium of Medium-Sized Regulatory Authorities. Ther Innov Regul Sci. 2017 Sep; 51(5):635-644.
McAuslane N, Leong J, Liberti L, Walker S. PMID: 30231684.
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PubMed Mentions:
10 Fields:
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Factors related to drug approvals: predictors of outcome? Drug Discov Today. 2017 06; 22(6):937-946.
Liberti L, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H. PMID: 28288783.
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PubMed Mentions:
4 Fields:
Translation:
Humans
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Health Technology Assessment (HTA) Case Studies: Factors Influencing Divergent HTA Reimbursement Recommendations in Australia, Canada, England, and Scotland. Value Health. 2017 Mar; 20(3):320-328.
Allen N, Walker SR, Liberti L, Salek S. PMID: 28292476.
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PubMed Mentions:
20 Fields:
Translation:
Humans
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Evaluating alignment between Canadian Common Drug Review reimbursement recommendations and provincial drug plan listing decisions: an exploratory study. CMAJ Open. 2016 Oct-Dec; 4(4):E674-E678.
Allen N, Walker SR, Liberti L, Sehgal C, Salek MS. PMID: 28018881; PMCID: PMC5173476.
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PubMed Mentions:
7 Fields:
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An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency. Ther Innov Regul Sci. 2016 Nov; 50(6):734-742.
Dörr P, Wadworth A, Wang T, McAuslane N, Liberti L. PMID: 30231740.
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PubMed Mentions:
4 Fields:
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Accelerating access to new medicines: Current status of facilitated regulatory pathways used by emerging regulatory authorities. J Public Health Policy. 2016 08; 37(3):315-333.
Liberti L, Breckenridge A, Hoekman J, Leufkens H, Lumpkin M, McAuslane N, Stolk P, Zhi K, Rägo L. PMID: 26961261.
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PubMed Mentions:
12 Fields:
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Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications. Oncologist. 2015 Jun; 20(6):683-91.
Liberti L, Stolk P, McAuslane JN, Schellens J, Breckenridge AM, Leufkens H. PMID: 25948678; PMCID: PMC4571776.
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PubMed Mentions:
1 Fields:
Translation:
Humans
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A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward? Ther Innov Regul Sci. 2015 Jan; 49(1):17-25.
Walker S, McAuslane N, Liberti L, Leong J, Salek S. PMID: 30222450.
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PubMed Mentions:
8 Fields:
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Characterizing Good Review Practices: A Survey Report Among Agencies of APEC Member Economies. Ther Innov Regul Sci. 2013 Nov; 47(6):678-683.
Liu LL, McAuslane N, Tzou MC, Chern HD, Liberti L, Ward M, Kang JJ. PMID: 30235555.
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PubMed Mentions:
3 Fields: