• Publications
• Papers and Reports
• Dissertations

Publications

2010

• Cornips, C., Rago, L., Azatyan, S., Laing R. (2010) Medicines Regulatory Authority websites: Review of progress made since 2001. International Journal of Risk & Safety in Medicine 22 (2010) 77–88
• Crommelin, D., Stolk, P., Besancon, L., Shah, V., Midha, K., Leufkens, H.G.M. (2010) Pharmaceutical sciences in 2020. Nature Reviews Drug Discovery; 9: 99-100
• Giezen, T.J., Mantel-Teeuwisse, Meyboom, R.H.B., Straus, S.M.J.M., Leufkens, H.G.M., Egberts T.C.G. (2010) Mapping the Safety Profile of Biologicals. A Disproportionality Analysis Using the WHO Adverse Drug Reaction Database, VigiBase. Drug Saf 2010; 33 (10): 865-878
• Heemstra, H.E., Giezen, T.J., Mantel-Teeuwisse, A.K., de Vrueh, R.L.A., Leufkens, H.G.M. (2010) Safety-Related Regulatory Actions for Orphan Drugs in the US and EU: A Cohort Study. Drug Safety. 00:0
• Luijn, J.C.F. van, Gribnau, F.W.J., Leufkens, H.G.M. (2010). Superior efficacy of new medicines? Eur J Clin Pharmacol 66:445–448
• Putzeist, M., Mantel-Teeuwisse, A.K., Gispen-De Wied, C.C., Hoes, A.W., Leufkens, H.G.M. (2010) Regulatory scientific advice in drug development: does company size make a difference? Eur J Clin Pharmacol Nov 4

2009

• Giezen, T.J., Mantel-Teeuwisse, A.K., Straus, S.M.J.M., Egberts, A.C.G., Blackburn, S., Persson, I., Leufkens, H.G.M. (2009). Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory. Drug Safety; 32 (12): 1175-1187.
• Giezen, T.J., Mantel-Teeuwisse, A.K., Leufkens, H.G.M. (2009). Pharmacovigilance of Biopharmaceuticals, Challenges Remain. Drug Safety; 32 (10): 811-817.
• Giezen, T.J., Straus, S.M.J.M., Mantel-Teeuwisse, A.K. (2009). Pharmacovigilance of biosimilars from a regulatory point of view: Is there a need for specific approach? International Journal of Risk & Safety in Medicine 21:53–58.
• Heemstra, H.E., Weely, S. van., Buller, H.A., Leufkens, H.G.M., Vrueh, R.L.A. de. Translation of rare disease research into orphan drug development: disease matters (2009) Drug Discovery Today; 14(23/24):1166-1173
• Heemstra, H.E., Meulenhoff, P.C.W., Weely, S. van., Leufkens, H.G.M. Apotheker maakt zelf weesgeneesmiddel (2009). Pharmaceutisch Weekblad 27 maart
• Heemstra, H.E., Weely, S. van., Buller, H.A., Leufkens, H.G.M., Vrueh, R.L.A. de. (2009). Translation of rare disease research into orphan drug development: disease matters. Drug Discov Today.
• Pieters, T., Snelders, S. (2009). Psychotropic Drug Use: Between Healing and Enhancing the Mind. Neuroethics 2:63–73.
• Stolk, P., Heemstra, H.E., Leufkens, H.G.M.,Bloechl-Daum, B., Heerdink, E.R. No difference in between-country variability in use of newly approved orphan and non- orphan medicinal products - a pilot study (2009) Orphanet Journal of Rare Diseases, 4:27-34
• Tafuri, G., Leufkens, H.G.M., Laing, R.O., Trotta, F., (2009). Therapeutic indications in oncology: Emerging features and regulatory dynamics. European Journal of Cancer.
• Tafuri, G., Trotta, F., Leufkens, H.G.M., Martini, N., Sagliocca. L., Traversa, G. (2009). Off-label use of medicines in children: can available evidence avoid useless paediatric trials? Eur J Clin Pharmacol 65:209–216.
• Waning, B., Kaplan, W., King, A.C., Lawrence, D.A., Leufkens, H.G.M., Fox, M.P. (2009). Global strategies to reduce the price of antiretroviral medicines: evidence from transactional databases. Bull World Health Organization 87:520–528.
• Willemen, M.J.C., Mantel-Teeuwisse, A.K., Straus, S.M.J.M., Leufkens H.G.M., Egberts, A.C.G., Sturkenboom, M.C.J.M. (2009). Cardiovascular and psychiatric risk profile and patterns of use in patients starting anti-obesity drugs. Pharmacoepidemiology and drug safety 18: 631–638.

2008

• Eichler, H.G., Pignatti, F., Flamion, B., Leufkens, H.G.M. & Breckenridge, A. (2008). Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nature Reviews. Drug Discovery, 7, 818-826.
• Giezen, T.J., Mantel-Teeuwisse, A.K., Straus, S.M.J.M., Schellekens, H., Leufkens, H.G.M. & Egberts, A.C.G. (2008). Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union. JAMA - The Journal of The American Medical Association, 300(16), 1887-1896.
• Heemstra, H.E., Vrueh, R.L. de, Weely, S van & Leufkens, H.G.M. (2008). Predictors of orphan drug approval in the European Union. European Journal of Clinical Pharmacology, 64, 545-552.
• Heemstra, H.E., Vrueh, R.L. de, Weely, S van, Bόller, H.A. & Leufkens, H.G.M. (2008). Orphan drug development across Europe: bottlenecks and opportunities. Drug Discovery Today, (June 08).
• Luijn, J.C.F. van, Stolk, P., Gribnau, F.W.J. & Leufkens, H.G.M. (2008). Gap in publication of comparative information on new medicines. British Journal of Clinical Pharmacology, 65(5), 716-722.
• Luijn, J.C.F. van, Loenen, A.C. van., Gribnau, F.W.J. & Leufkens, H.G.M. (2008). Choice of Comparator in Active Control Trials of New Drugs. The Annals of Pharmacotherapy, November, Volume 42;1605-1612.
• Stolk, P., Belitser, S.V., Leufkens, H.G.M., Heerdink, E.R. (2008). Variable Access to Clopidogrel in a Harmonized EU Market. Value in Health. Volume 11, Number 5, 989-995.
• Stolk, P., Schneeweiss, S., Leufkens, H.G.M., Heerdink, E.R. (2008). Impact analysis of the discontinuation of reimbursement: the case of oral contraceptives. Contraception 2008;78(5). 399-404.
• Willemen, M.J.C., Mantel-Teeuwisse, A.K., Straus, S.M.J.M., Leufkens H.G.M., Egberts, A.C.G. (2008). Psychiatric and Cardiovascular Comorbidities in Patients With Diabetes Mellitus Starting Antiobesity Drugs. Obesity. Volume 16, 10;2331-2335.

2007

• Giezen, T.J., Straus, S.M.J.M. (2007). Risk management of biopharmaceuticals: a regulatory perspective. EJHP Practice. Volume 13, 2007/6. 72-74.
• Luijn J.C. van, Gribnau F.W., Leufkens H.G.M. (2007). Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Pharmacol. Feb;63(2):159-62.
• Florentinus S.R., Hulten R. van., Kloth M.E.M., Heerdink E.R., Griens F.A.M.G., Leufkens H.G.M., Groenewegen P.P. (2007). The Effect of Pharmacotherapy Audit Meetings on Early New Drug Prescribing by General Practitioners. The Annals of Pharmacotherapy, February, Volume 41
• Stolk, P., Souverein P.C., Leufkens, H.G.M., Weil. J.G., Heerdink, E.R. (2007). The association between Exposure to COX-23 inhibitors and Schizophrenia Deterioration. A Nested Case-Control Study. Pharmacopsychiatry; 40:111-115.

2006

• Florentinus S.R., Souverein P.C., Griens F.A.M.G., Groenewegen P.P., Leufkens H.G.M., Heerdink E.R. (2006). Linking community pharmacy dispensing data to prescribing data of general practitioners. BMC Medical Informatics and Decision Making, 6:18
• Florentinus S.R., Hulten R. van., Kramer M., Dijk L. van., Heerdink E.R., Leufkens H.G.M., Groenewegen P.P.(2006). Which Pharmacists Contribute to High-Level Pharmacotherapy Audit Meetings with General Practitioners? The Annals of Pharmacotherapy, September, Volume 40.
• Stolk, P., Wijk, B.L.G. van., Leufkens, H.G.M., Heerdink, E.R. (2006). Between-country variation in the utilization of antihypertensive agents: guidelines and clinical practice. Journal of Human Hypertension (2006), 1–6.
• Stolk, P., Willemen M.J.C., Leufkens, H.G.M. (2006). "Rare essentials": drugs for rare diseases as essential medicines. Bulletin of the World Health Organization. September 2006, 84(9): 745-751.

2005

• Florentinus S.R., Nielsen M.W., Dijk L. van., Leufkens H.G.M., Holme Hansen E., Heerdink E.R. (2005) Patient characteristics associated with prescribing of a newly introduced drug: the case of rofecoxib. Eur J Clin Pharmacol 61: 157–159
• Florentinus S.R., Heerdink E.R., Boer A.T. de, Dijk L. van., Leufkens H.G.M. (2005). The trade-off between cardiovascular and gastrointestinal effects of rofecoxib. pharmacoepidemiology and drug safety; 14: 437–441
• Stolk, P., Heerdink, E.R., Leufkens, H.G.M. (2005). Changes in the defined daily dose; CYP2D6/CYP3A metabolism as an indicator for dose-setting problems. Eur J Clin Pharmacol 61: 243–246.

2002

• Zwart-van Rijkom J.E.F., Broekmans A.W., Leufkens H.G.M. (2002). Perspective on Medical Pracitce: From HMG through purified urinary FSH preparations to recombinant FSH: a substitution study. Human Reproduction. Volume 17: No. 4; 857-865
• Zwart-van Rijkom J.E.F., Plug I., Rosendaal F.R., Leufkens H.G.M., Broekmans A.W. (2002)The uptake of recombinant Factor VIII in the Netherlands. British Journal of Haematology, 119, 332–341
• Zwart-van Rijkom J.E.F., Leufkens H.G.M., Simoons M.L., Broekmans A.W. (2002) Variability in abciximab (ReoPro1) prescribing: evidence based or budget driven? Pharmacoepidemiology and drug safety; 11: 135–141

2001

• Zwart-van Rijkom J.E.F., van Hout B.V. (2001). Cost-efficacy in interventional cardiology Results from the EPISTENT study. European Heart Journal 22, 1476–1484
• Zwart-van Rijkom K.E.F., Klungel O.H., Leufkens H.G.M., Broekmans A.W., Schrijver-van Velthoven S., Umans V.A. (2001). Costs and effects of combining stenting and abciximab (ReoPro ) in daily practice. International Journal of Cardiology 77;299–303

2000

• Zwart-van Rijkom J.E.F., Leufkens H.G.M., Busschbach J.J.V., Broekmans A.W., Rutten F.F.H., Differences in Attitudes, Knowledge and Use of Economic Evaluations in Decision-Making in The Netherlands The Dutch Results from the EUROMET Project. Pharmacoeconomics Aug; 18 (2): 149-160

1999

• Rijkom J. van, Leufkens H.G.M., Crommelin D., Rutten F., Broekmans A. (1999). Assessment of biotechnology drugs: what are the issues? Health Policy;47;255–27

Papers and Reports

• Dongen van, S., (2010) Websites reporting medicine prices: a comparative analysis. Utrecht University, WHO CC for Pharmacoepidemiology & Pharmaceutical Policy Analysis. Intern at Essential Medicines and Pharmaceutical Policies department, World Health Organization, Geneva, Switzerland 2010
• Parsi, P. Process evaluation of 'Country Profiles', 2010. Utrecht University, WHO CC for Pharmacoepidemiology & Pharmaceutical Policy Analysis, 2010. Further information on data can be found in the annex
• Buysse, I.M. Impact of the economic recession on the pharmaceutical sector. Utrecht University, WHO CC for Pharmacoepidemiology & Pharmaceutical Policy Analysis, 2010.
• Ham van den, R. Selection of Essential Medicines - a background paper for the World Medicines Situation 2010 report. Utrecht University, WHO CC for Pharmacoepidemiology & Pharmaceutical Policy Analysis, 2009. Further information on data can be found in annex 1, annex 2, annex 3, annex 4, annex 5 and annex 6.
• Volman, B. Direct costs and availability of diabetes medicines in low-income and middle-income countries. Utrecht University, internship at HAI Europe, 2008
• Putzeist, M. Self-Regulation of Drug Promotion. February 2007
• Leufkens, H.G.M. Background paper to the Priority Medicines Report: 7.5 Orphan Diseases, 2004
• Willemen M.J.C., Ververs F., Leufkens H.G.M. Background paper to the Priority Medicines Report: 7.4 Pharmaceuticals and Women, 2004
• Zuidgeest M.G.P., Willemen M.J.C., Leufkens H.G.M. Background paper to the Priority Medicines Report: 7.3 Pharmaceuticals and Children, 2004
• Willemen M.J.C. Background paper to the Priority Medicines Report: 7.2 Pharmaceuticals and the Elderly, 2004.
• Kaplan, W., Laing, R., Priority medicines for Europe and the world. Geneva, World Health Organization, 2004.

Dissertations

• Heemstra, H. (2010)
  From research on rare diseases to new orphan drug development. Universiteit Utrecht, 186 pp. (Co-) promot.: Prof. dr. H.G.M. Leufkens, Prof. dr. H.A. Buller, Dr. S. van Weely, Dr. R.L.A. de Vrueh.
• Luijn van, J. (2010)
  Comparative information on new medicines. Universiteit Utrecht, 167 pp. (Co-) promot.: Prof. dr. F.W.J. Gribnau, Prof. dr. H.G.M. Leufkens
• Stolk, P. (2009)
  From new molecules to leads for innovation Universiteit Utrecht, 223 pp. (Co-) promot.: Prof. dr. H.G.M. Leufkens, Dr. E.R. Heerdink.
• Florentinus, S.R. (2006)
  New drugs in general practice, Prescribing patterns and external influences. Universiteit Utrecht, 188 pp. (Co-)promot.: Prof.dr. H. G. M. Leufkens, Prof. dr. P.P. Groenewegen, Dr E.R. Heerdink, Dr. ir. L. van Dijk.
• Zwart - van Rijkom, J.E.F. (2002)
  Assessment and diffusion of biotechnology drugs. Universiteit Utrecht, 175 pp. (Co-)promot.: Prof. Dr. A. W. Broekmans, Prof. dr. F. F. H. Rutten