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Efficacy gap between phase II and subsequent phase III studies in oncology.

Vreman RA, Belitser SV, Mota ATM, Hövels AM, Goettsch WG, Roes KCB, Leufkens HGM, Mantel-Teeuwisse AK.

Br J Clin Pharmacol. 2020 Feb 7. doi: 10.1111/bcp.14237. [Epub ahead of print]


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

Liberti L, McAuslane N, Stolk P, Breckenridge A, Leufkens H.

Ther Innov Regul Sci. 2020 Jan;54(1):55-68. doi: 10.1007/s43441-019-00029-x. Epub 2020 Jan 6.


Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations.

Vreman RA, Mantel-Teeuwisse AK, Hövels AM, Leufkens HGM, Goettsch WG.

Value Health. 2020 Jan;23(1):10-16. doi: 10.1016/j.jval.2019.07.017.


Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection.

Ten Ham RMT, Hövels AM, Klungel OH, Leufkens HGM, Broekmans AW, Hoekman J.

Trends Pharmacol Sci. 2020 Feb;41(2):67-71. doi: 10.1016/ Epub 2020 Jan 13.


Selection of Blood, Blood Components, and Blood Products as Essential Medicines in 105 Low- and Middle-Income Countries.

Samukange WT, Gardarsdottir H, Leufkens HGM, Mantel-Teeuwisse AK.

Transfus Med Rev. 2019 Nov 9. pii: S0887-7963(19)30147-6. doi: 10.1016/j.tmrv.2019.10.005. [Epub ahead of print] Review.


Pharmacy-led pharmacovigilance: Ready for use or missed opportunity?

Leufkens HG.

Pharmacoepidemiol Drug Saf. 2019 Dec;28(12):1562. doi: 10.1002/pds.4901. Epub 2019 Nov 12. No abstract available.


Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions.

Vreman RA, Heikkinen I, Schuurman A, Sapede C, Garcia JL, Hedberg N, Athanasiou D, Grueger J, Leufkens HGM, Goettsch WG.

Value Health. 2019 Nov;22(11):1275-1282. doi: 10.1016/j.jval.2019.07.007. Epub 2019 Sep 6.


Intensive monitoring of adverse drug events associated with the use of new glucose-lowering drugs: results from an inception cohort study in Portugal.

Torre C, Guerreiro J, Longo P, Raposo JF, Leufkens H, Martins AP.

Diabet Med. 2019 Nov 6. doi: 10.1111/dme.14168. [Epub ahead of print]


Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.

Torre C, Cary M, Borges FC, Ferreira PS, Alarcão J, Leufkens HG, Costa J, Martins AP.

Front Med (Lausanne). 2019 Jul 19;6:147. doi: 10.3389/fmed.2019.00147. eCollection 2019.


Tenofovir-associated renal toxicity in a cohort of HIV infected patients in Ghana.

Nartey ET, Tetteh RA, Yankey BA, Mantel-Teeuwisse AK, Leufkens HGM, Dodoo ANO, Lartey M.

BMC Res Notes. 2019 Jul 22;12(1):445. doi: 10.1186/s13104-019-4454-2.


Phase I/II Clinical Trial-Based Early Economic Evaluation of Acalabrutinib for Relapsed Chronic Lymphocytic Leukaemia.

Vreman RA, Geenen JW, Hövels AM, Goettsch WG, Leufkens HGM, Al MJ.

Appl Health Econ Health Policy. 2019 Dec;17(6):883-893. doi: 10.1007/s40258-019-00496-1.


Added therapeutic value of new drugs approved in Brazil from 2004 to 2016.

Hoefler R, Alves TL, Leufkens HG, Naves JOS.

Cad Saude Publica. 2019 May 23;35(5):e00070018. doi: 10.1590/0102-311X00070018.


Regulatory science: Regulation is too important to leave it to the regulators.

Leufkens HG.

Br J Clin Pharmacol. 2019 Apr 10. doi: 10.1111/bcp.13917. [Epub ahead of print] No abstract available.


The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations.

Klein K, Stolk P, De Bruin ML, Leufkens HGM, Crommelin DJA, De Vlieger JSB.

Eur J Pharm Sci. 2019 May 15;133:228-235. doi: 10.1016/j.ejps.2019.03.029. Epub 2019 Apr 3. Review.


The accuracy of date of death recording in the Clinical Practice Research Datalink GOLD database in England compared with the Office for National Statistics death registrations.

Gallagher AM, Dedman D, Padmanabhan S, Leufkens HGM, de Vries F.

Pharmacoepidemiol Drug Saf. 2019 May;28(5):563-569. doi: 10.1002/pds.4747. Epub 2019 Mar 25.


Identification of potentially inappropriate medications with risk of major adverse cardiac and cerebrovascular events among elderly patients in ambulatory setting and long-term care facilities.

Aguiar JP, Heitor Costa L, Alves da Costa F, Leufkens HG, Martins AP.

Clin Interv Aging. 2019 Mar 4;14:535-547. doi: 10.2147/CIA.S192252. eCollection 2019.


Potentially inappropriate medications with risk of cardiovascular adverse events in the elderly: A systematic review of tools addressing inappropriate prescribing.

Aguiar JP, Brito AM, Martins AP, Leufkens HGM, Alves da Costa F.

J Clin Pharm Ther. 2019 Jun;44(3):349-360. doi: 10.1111/jcpt.12811. Epub 2019 Feb 11.


Prescribing patterns and compliance with World Health Organization recommendations for the management of severe malaria: a modified cohort event monitoring study in public health facilities in Ghana and Uganda.

Ampadu HH, Asante KP, Bosomprah S, Akakpo S, Hugo P, Gardarsdottir H, Leufkens HGM, Kajungu D, Dodoo ANO.

Malar J. 2019 Feb 8;18(1):36. doi: 10.1186/s12936-019-2670-9.


Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study.

Minnema LA, Giezen TJ, Souverein PC, Egberts TCG, Leufkens HGM, Gardarsdottir H.

Drug Saf. 2019 Jul;42(7):887-895. doi: 10.1007/s40264-018-00789-9.


Post-marketing dosing changes in the label of biologicals.

Minnema LA, Giezen TJ, Gardarsdottir H, Egberts TCG, Leufkens HGM, Mantel-Teeuwisse AK.

Br J Clin Pharmacol. 2019 Apr;85(4):715-721. doi: 10.1111/bcp.13843. Epub 2019 Feb 16.


Health-related quality of life in adults with type 2 diabetes mellitus starting with new glucose lowering drugs: An inception cohort study.

Torre C, Guerreiro J, Longo P, Raposo JF, Leufkens H, Martins AP.

Prim Care Diabetes. 2019 Jun;13(3):221-232. doi: 10.1016/j.pcd.2018.11.009. Epub 2018 Dec 17.


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

Liberti L, McAuslane N, Stolk P, Breckenridge A, Leufkens H.

Ther Innov Regul Sci. 2018 Dec 6:2168479018813977. doi: 10.1177/2168479018813977. [Epub ahead of print]


Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe.

Ten Ham RMT, Hoekman J, Hövels AM, Broekmans AW, Leufkens HGM, Klungel OH.

Mol Ther Methods Clin Dev. 2018 Oct 11;11:121-130. doi: 10.1016/j.omtm.2018.10.003. eCollection 2018 Dec 14.


Organizational capacities of national pharmacovigilance centres in Africa: assessment of resource elements associated with successful and unsuccessful pharmacovigilance experiences.

Ampadu HH, Hoekman J, Arhinful D, Amoama-Dapaah M, Leufkens HGM, Dodoo ANO.

Global Health. 2018 Nov 16;14(1):109. doi: 10.1186/s12992-018-0431-0.


Drug Shortages From the Perspectives of Authorities and Pharmacy Practice in the Netherlands: An Observational Study.

Postma DJ, De Smet PAGM, Gispen-de Wied CC, Leufkens HGM, Mantel-Teeuwisse AK.

Front Pharmacol. 2018 Oct 31;9:1243. doi: 10.3389/fphar.2018.01243. eCollection 2018.


Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems.

Roth L, Bempong D, Babigumira JB, Banoo S, Cooke E, Jeffreys D, Kasonde L, Leufkens HGM, Lim JCW, Lumpkin M, Mahlangu G, Peeling RW, Rees H, Ndomondo-Sigonda M, Stergachis A, Ward M, Nwokike J.

Global Health. 2018 Nov 1;14(1):102. doi: 10.1186/s12992-018-0421-2. Review.


Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs.

Vreman RA, Bouvy JC, Bloem LT, Hövels AM, Mantel-Teeuwisse AK, Leufkens HGM, Goettsch WG.

Clin Pharmacol Ther. 2019 Mar;105(3):684-691. doi: 10.1002/cpt.1251. Epub 2018 Nov 8.


Precision medicine in diabetes and diabetic kidney disease: Regulatory considerations.

Mol PGM, Thompson A, Heerspink HJL, Leufkens HGM.

Diabetes Obes Metab. 2018 Oct;20 Suppl 3:19-23. doi: 10.1111/dom.13453. Review.


The future of drug development: the paradigm shift towards systems therapeutics.

Danhof M, Klein K, Stolk P, Aitken M, Leufkens H.

Drug Discov Today. 2018 Dec;23(12):1990-1995. doi: 10.1016/j.drudis.2018.09.002. Epub 2018 Sep 10. Review.


Dose-Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis.

Schuller Y, Gispen-de Wied C, Hollak CEM, Leufkens HGM, Stoyanova-Beninska V.

J Clin Pharmacol. 2019 Feb;59(2):229-244. doi: 10.1002/jcph.1304. Epub 2018 Sep 7.


Effect of different methods for estimating persistence and adherence to new glucose-lowering drugs: results of an observational, inception cohort study in Portugal.

Torre C, Guerreiro J, Longo P, Raposo JF, Leufkens H, Martins AP.

Patient Prefer Adherence. 2018 Aug 17;12:1471-1482. doi: 10.2147/PPA.S170134. eCollection 2018.


The use of real-world data in cancer drug development.

Skovlund E, Leufkens HGM, Smyth JF.

Eur J Cancer. 2018 Sep;101:69-76. doi: 10.1016/j.ejca.2018.06.036. Epub 2018 Jul 18.


Increased risk of all-cause mortality associated with domperidone use in Parkinson's patients: a population-based cohort study in the UK.

Simeonova M, de Vries F, Pouwels S, Driessen JHM, Leufkens HGM, Cadarette SM, Burden AM.

Br J Clin Pharmacol. 2018 Nov;84(11):2551-2561. doi: 10.1111/bcp.13708. Epub 2018 Aug 9.


Postauthorization Changes to Specific Obligations of Conditionally Authorized Medicines in the European Union: A Retrospective Cohort Study.

Bloem LT, Mantel-Teeuwisse AK, Leufkens HGM, De Bruin ML, Klungel OH, Hoekman J.

Clin Pharmacol Ther. 2019 Feb;105(2):426-435. doi: 10.1002/cpt.1169. Epub 2018 Aug 12.


Response to proposal for a novel cancer drug pricing model.

van der Gronde T, Leufkens HG, Pieters T.

Nat Rev Clin Oncol. 2018 Aug;15(8):528. doi: 10.1038/s41571-018-0062-7. No abstract available.


Selection of essential medicines for the prevention and treatment of cardiovascular diseases in low and middle income countries.

Bazargani YT, Ugurlu M, de Boer A, Leufkens HGM, Mantel-Teeuwisse AK.

BMC Cardiovasc Disord. 2018 Jun 25;18(1):126. doi: 10.1186/s12872-018-0858-5.


Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions.

Wang T, McAuslane N, Liberti L, Leufkens H, Hövels A.

Value Health. 2018 Jun;21(6):707-714. doi: 10.1016/j.jval.2017.11.003. Epub 2017 Dec 9.


Cancer recording in patients with and without type 2 diabetes in the Clinical Practice Research Datalink primary care data and linked hospital admission data: a cohort study.

Williams R, van Staa TP, Gallagher AM, Hammad T, Leufkens HGM, de Vries F.

BMJ Open. 2018 May 26;8(5):e020827. doi: 10.1136/bmjopen-2017-020827.


A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

Coppens DGM, de Wilde S, Guchelaar HJ, De Bruin ML, Leufkens HGM, Meij P, Hoekman J.

Cytotherapy. 2018 Jun;20(6):769-778. doi: 10.1016/j.jcyt.2018.03.038. Epub 2018 May 2.


Safety Experience During Real-World Use of Injectable Artesunate in Public Health Facilities in Ghana and Uganda: Outcomes of a Modified Cohort Event Monitoring Study (CEMISA).

Ampadu HH, Dodoo ANO, Bosomprah S, Akakpo S, Hugo P, Gardarsdottir H, Leufkens HGM, Kajungu D, Asante KP.

Drug Saf. 2018 Sep;41(9):871-880. doi: 10.1007/s40264-018-0667-x.


Access to Strong Opioid Analgesics in the Context of Legal and Regulatory Barriers in Eleven Central and Eastern European Countries.

Vranken MJM, Mantel-Teeuwisse AK, Schutjens MDB, Scholten WK, Jünger S, Leufkens HGM.

J Palliat Med. 2018 Jul;21(7):963-969. doi: 10.1089/jpm.2017.0595. Epub 2018 Apr 6.


EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

de Wilde S, Coppens DGM, Hoekman J, de Bruin ML, Leufkens HGM, Guchelaar HJ, Meij P.

Drug Discov Today. 2018 Jul;23(7):1328-1333. doi: 10.1016/j.drudis.2018.03.008. Epub 2018 Mar 21. Review.


Evidence Synthesis in Harm Assessment of Medicines Using the Example of Rosiglitazone and Myocardial Infarction.

Rietbergen C, Stefansdottir G, Leufkens HG, Knol MJ, De Bruin ML, Klugkist I.

Front Med (Lausanne). 2018 Feb 22;4:228. doi: 10.3389/fmed.2017.00228. eCollection 2017.


Change in parental knowledge, attitudes and practice of antibiotic use after a national intervention programme.

Ivanovska V, Angelovska B, van Dijk L, Zdravkovska M, Leufkens HG, Mantel-Teeuwisse AK.

Eur J Public Health. 2018 Aug 1;28(4):724-729. doi: 10.1093/eurpub/ckx240.


Renal function of MDR-TB patients treated with kanamycin regimens or concomitantly with antiretroviral agents.

Sagwa EL, Ruswa N, Mavhunga F, Rennie T, Mengistu A, Mekonen TT, Leufkens HGM, Mantel-Teeuwisse AK.

Int J Tuberc Lung Dis. 2017 Dec 1;21(12):1245-1250. doi: 10.5588/ijtld.16.0953.


Reporting of adverse events following immunizations in Ghana - Using disproportionality analysis reporting ratios.

Ankrah DNA, Darko DM, Sabblah G, Mantel-Teeuwisse A, Leufkens HMG.

Hum Vaccin Immunother. 2018 Jan 2;14(1):172-178. doi: 10.1080/21645515.2017.1384105. Epub 2017 Nov 27.


Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European risk management plans.

Lepelaars LRA, Renda F, Pani L, Pimpinella G, Leufkens HGM, Trifirò G, Tafuri G, Mantel-Teeuwisse AK, Trotta F.

Br J Clin Pharmacol. 2018 Apr;84(4):738-763. doi: 10.1111/bcp.13454. Epub 2018 Jan 18.


Variability in market uptake of psychotropic medications in Europe reflects cultural diversity.

Hoebert JM, Mantel-Teeuwisse AK, Leufkens HGM, van Dijk L.

BMC Health Serv Res. 2017 Nov 6;17(1):702. doi: 10.1186/s12913-017-2649-6.


Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation.

Coppens DGM, De Bruin ML, Leufkens HGM, Hoekman J.

Clin Pharmacol Ther. 2018 Jan;103(1):120-127. doi: 10.1002/cpt.894. Epub 2017 Nov 6. Review.


Pharmacological vs. classical approaches in the design of first in man clinical drug trials.

van den Bogert CA, Cohen AF, Leufkens HGM, van Gerven JMA.

Br J Clin Pharmacol. 2017 Dec;83(12):2807-2812. doi: 10.1111/bcp.13422. Epub 2017 Oct 6.

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