Lawrence Liberti

Title(s)Associate Professor of Regulatory and Quality Sciences (Teaching Track) and Director of the D.K. Kim International Center for Regulatory Science
SchoolUSC School of Pharmacy
Phone+1 323 442 0933
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    Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Researchers can login to make corrections and additions, or contact us for help. to make corrections and additions.
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    Altmetrics Details PMC Citations indicate the number of times the publication was cited by articles in PubMed Central, and the Altmetric score represents citations in news articles and social media. (Note that publications are often cited in additional ways that are not shown here.) Fields are based on how the National Library of Medicine (NLM) classifies the publication's journal and might not represent the specific topic of the publication. Translation tags are based on the publication type and the MeSH terms NLM assigns to the publication. Some publications (especially newer ones and publications not in PubMed) might not yet be assigned Field or Translation tags.) Click a Field or Translation tag to filter the publications.
    1. 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.
      View in: PubMed   Mentions: 5     Fields:    
    2. 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.
      View in: PubMed   Mentions:    Fields:    Translation:HumansPHPublic Health
    3. 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.
      View in: PubMed   Mentions:    Fields:    
    4. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:Humans
    5. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:Humans
    6. 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.
      View in: PubMed   Mentions: 4  
    7. 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.
      View in: PubMed   Mentions: 12  
    8. 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.
      View in: PubMed   Mentions: 2  
    9. 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.
      View in: PubMed   Mentions:    Fields:    
    10. 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.
      View in: PubMed   Mentions: 5     Fields:    Translation:Humans
    11. 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.
      View in: PubMed   Mentions: 4     Fields:    Translation:Humans
    12. 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.
      View in: PubMed   Mentions: 8     Fields:    
    13. 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.
      View in: PubMed   Mentions: 5     Fields:    
    14. 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.
      View in: PubMed   Mentions: 5     Fields:    Translation:Humans
    15. 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.
      View in: PubMed   Mentions: 6     Fields:    Translation:Humans
    16. Accelerated approval of medicines: fit for purpose? Nat Rev Drug Discov. 2018 06; 17(6):379-380. Breckenridge A, Liberti L. PMID: 29302066.
      View in: PubMed   Mentions: 3     Fields:    Translation:Humans
    17. 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.
      View in: PubMed   Mentions: 18     Fields:    Translation:Humans
    18. 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.
      View in: PubMed   Mentions: 22  
    19. 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.
      View in: PubMed   Mentions: 12  
    20. 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.
      View in: PubMed   Mentions: 10     Fields:    
    21. 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.
      View in: PubMed   Mentions: 4     Fields:    Translation:Humans
    22. 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.
      View in: PubMed   Mentions: 21     Fields:    Translation:Humans
    23. 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.
      View in: PubMed   Mentions: 7     Fields:    
    24. 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.
      View in: PubMed   Mentions: 4     Fields:    
    25. 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.
      View in: PubMed   Mentions: 12     Fields:    
    26. 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.
      View in: PubMed   Mentions: 1     Fields:    Translation:Humans
    27. 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.
      View in: PubMed   Mentions: 8     Fields:    
    28. 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.
      View in: PubMed   Mentions: 3     Fields:    
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    NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.

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