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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.


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. Review.


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.


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.


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.


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.


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.


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.


Five-year trends in treatment changes in an adult cohort of HIV/AIDS patients in Ghana: a retrospective cohort study.

Ankrah DNA, Lartey M, Mantel-Teeuwisse AK, Leufkens HGM.

BMC Infect Dis. 2017 Oct 2;17(1):664. doi: 10.1186/s12879-017-2752-7.


When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection.

Klein K, Scholl JHG, De Bruin ML, van Puijenbroek EP, Leufkens HGM, Stolk P.

Clin Pharmacol Ther. 2018 Feb;103(2):296-303. doi: 10.1002/cpt.879. Epub 2017 Oct 25.


Age-Specific Antibiotic Prescribing and Adherence to Guidelines in Pediatric Patients in Primary Care.

Ivanovska V, Hek K, Mantel-Teeuwisse AK, Leufkens HGM, van Dijk L.

Pediatr Infect Dis J. 2018 Mar;37(3):218-223. doi: 10.1097/INF.0000000000001757.


[Non-publication is common among phase 1, single-center, not prospectively registered, or early terminated clinical drug trials].

van den Bogert CA, Souverein PC, Brekelmans CTM, Janssen SWJ, Koëter GH, Leufkens HGM, Bouter LM.

Ned Tijdschr Geneeskd. 2017;161:D1498. Dutch.


Primary endpoint discrepancies were found in one in ten clinical drug trials. Results of an inception cohort study.

van den Bogert CA, Souverein PC, Brekelmans CTM, Janssen SWJ, Koëter GH, Leufkens HGM, Bouter LM.

J Clin Epidemiol. 2017 Sep;89:199-208. doi: 10.1016/j.jclinepi.2017.05.012. Epub 2017 May 20.


Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands.

van den Bogert CA, Souverein PC, Brekelmans CTM, Janssen SWJ, Koëter GH, Leufkens HGM, Bouter LM.

J Clin Epidemiol. 2017 Aug;88:140-147. doi: 10.1016/j.jclinepi.2017.05.001. Epub 2017 May 6.


Risk of infections in patients with gout: a population-based cohort study.

Spaetgens B, de Vries F, Driessen JHM, Leufkens HG, Souverein PC, Boonen A, van der Meer JWM, Joosten LAB.

Sci Rep. 2017 May 3;7(1):1429. doi: 10.1038/s41598-017-01588-5.


The impact of quality-of-life data in relative effectiveness assessments of new anti-cancer drugs in European countries.

Kleijnen S, Leonardo Alves T, Meijboom K, Lipska I, De Boer A, Leufkens HG, Goettsch WG.

Qual Life Res. 2017 Sep;26(9):2479-2488. doi: 10.1007/s11136-017-1574-9. Epub 2017 Apr 11.


Health system productivity change in Zambia: A focus on the child health services.

Achoki T, Kinfu Y, Masiye F, Frederix GWJ, Hovels A, Leufkens HG.

J Public Health Policy. 2017 Feb;38(1):88-104. doi: 10.1057/s41271-016-0046-8.


Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns.

Tetteh RA, Yankey BA, Nartey ET, Lartey M, Leufkens HG, Dodoo AN.

Drug Saf. 2017 Apr;40(4):273-283. doi: 10.1007/s40264-017-0505-6. Review.


Are age-appropriate antibiotic formulations missing from the WHO list of essential medicines for children? A comparison study.

Ivanovska V, Leufkens HG, Rademaker CM, Zisovska E, Pijnenburg MW, van Dijk L, Mantel-Teeuwisse AK.

Arch Dis Child. 2017 Apr;102(4):352-356. doi: 10.1136/archdischild-2016-311933. Epub 2017 Jan 24.


[Immunogenicity of biosimilars].

van Aerts LA, Franken AA, Leufkens HG.

Ned Tijdschr Geneeskd. 2016;160:D888. Review. Dutch.


Non-Publication Is Common among Phase 1, Single-Center, Not Prospectively Registered, or Early Terminated Clinical Drug Trials.

van den Bogert CA, Souverein PC, Brekelmans CT, Janssen SW, Koëter GH, Leufkens HG, Bouter LM.

PLoS One. 2016 Dec 14;11(12):e0167709. doi: 10.1371/journal.pone.0167709. eCollection 2016.


Long-term use of dipeptidyl peptidase-4 inhibitors and risk of fracture: A retrospective population-based cohort study.

Driessen JH, van den Bergh JP, van Onzenoort HA, Henry RM, Leufkens HG, de Vries F.

Diabetes Obes Metab. 2017 Mar;19(3):421-428. doi: 10.1111/dom.12843. Epub 2017 Jan 19.


Learning from patients: Identifying design features of medicines that cause medication use problems.

Notenboom K, Leufkens HG, Vromans H, Bouvy ML.

Int J Pharm. 2017 Jan 30;517(1-2):128-134. doi: 10.1016/j.ijpharm.2016.12.004. Epub 2016 Dec 5.


Adverse events and patients' perceived health-related quality of life at the end of multidrug-resistant tuberculosis treatment in Namibia.

Sagwa EL, Ruswa N, Mavhunga F, Rennie T, Leufkens HG, Mantel-Teeuwisse AK.

Patient Prefer Adherence. 2016 Nov 23;10:2369-2377. eCollection 2016.


Use of incretin agents and risk of acute and chronic pancreatitis: A population-based cohort study.

Knapen LM, de Jong RG, Driessen JH, Keulemans YC, van Erp NP, De Bruin ML, Leufkens HG, Croes S, de Vries F.

Diabetes Obes Metab. 2017 Mar;19(3):401-411. doi: 10.1111/dom.12833. Epub 2017 Feb 7.


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