OpenURL Connection Search

Select item for more details and to access through your institution.

Regulatory watch: Outcomes of EMA marketing authorization applications: does partnering have an influence?
Published in:
Nature Reviews Drug Discovery, 2014, v. 13, n. 12, p. 878, doi. 10.1038/nrd4468
By:
- van den Bogert, Cornelis A.;
- Souverein, Patrick C.;
- Putzeist, Michelle;
- Leufkens, Hubert G. M.;
- Janssen, Susan W. J.;
- Koëter, Gerard H.
Publication type:
Article
Appropriate evidence for adaptive marketing authorization.
Published in:
2013
By:
- de Jong, Jean Philippe;
- Grobbee, Diederick E;
- Flamion, Bruno;
- Forda, Susan R;
- Leufkens, Hubert G M
Publication type:
journal article
Appropriate evidence for adaptive marketing authorization.
Published in:
Nature Reviews Drug Discovery, 2013, v. 12, n. 9, p. 647, doi. 10.1038/nrd4114
By:
- de Jong, Jean Philippe;
- Grobbee, Diederick E.;
- Flamion, Bruno;
- Forda, Susan R.;
- Leufkens, Hubert G. M.
Publication type:
Article
Factors influencing non-approval of new drugs in Europe.
Published in:
Nature Reviews Drug Discovery, 2012, v. 11, n. 12, p. 903, doi. 10.1038/nrd3894
By:
- Putzeist, Michelle;
- Mantel-Teeuwisse, Aukje K.;
- Aronsson, Bo;
- Rowland, Malcolm;
- Gispen-de Wied, Christine C.;
- Vamvakas, Spiros;
- Hoes, Arno W.;
- Leufkens, Hubert G. M.;
- Eichler, Hans-Georg
Publication type:
Article
Switching TNFα inhibitors: Patterns and determinants.
Published in:
Pharmacology Research & Perspectives, 2021, v. 9, n. 4, p. 1, doi. 10.1002/prp2.843
By:
- Meijboom, Rosanne W.;
- Gardarsdottir, Helga;
- Becker, Matthijs L.;
- de Groot, Mark C. H.;
- Movig, Kris L. L.;
- Kuijvenhoven, Johan;
- Egberts, Toine C. G.;
- Leufkens, Hubert G. M.;
- Giezen, Thijs J.
Publication type:
Article
Challenges and Opportunities for Companies to Build HTA/Payer Perspectives Into Drug Development Through the Use of a Dynamic Target Product Profile.
Published in:
Frontiers in Pharmacology, 2022, v. 13, p. 1, doi. 10.3389/fphar.2022.948161
By:
- Ting Wang;
- McAuslane, Neil;
- Goettsch, Wim G.;
- Leufkens, Hubert G. M.;
- De Bruin, Marie L.
Publication type:
Article
Reasons for and time to discontinuation of rimonabant therapy: a modified prescription-event monitoring study.
Published in:
2012
By:
- Willemen MJ;
- Mantel-Teeuwisse AK;
- Buggy Y;
- Layton D;
- Straus SM;
- Leufkens HG;
- Egberts TC;
- Willemen, Marjolein J C;
- Mantel-Teeuwisse, Aukje K;
- Buggy, Yvonne;
- Layton, Deborah;
- Straus, Sabine M J M;
- Leufkens, Hubert G M;
- Egberts, Toine C G
Publication type:
journal article
Reasons for and Time to Discontinuation of Rimonabant Therapy A Modified Prescription-Event Monitoring Study.
Published in:
Drug Safety, 2012, v. 35, n. 12, p. 1147, doi. 10.2165/11631330-000000000-00000
By:
- Willemen, Marjolein J. C.;
- Mantel-Teeuwisse, Aukje K.;
- Buggy, Yvonne;
- Layton, Deborah;
- Straus, Sabine M. J. M;
- Leufkens, Hubert G. M.;
- Egberts, Tome C. G.
Publication type:
Article
A cohort study exploring determinants of safety-related regulatory actions for biopharmaceuticals.
Published in:
2012
By:
- Ebbers HC;
- Mantel-Teeuwisse AK;
- Moors EH;
- Sayed Tabatabaei FA;
- Schellekens H;
- Leufkens HG;
- Ebbers, Hans C;
- Mantel-Teeuwisse, Aukje K;
- Moors, Ellen H M;
- Sayed Tabatabaei, Fakhredin A;
- Schellekens, Huub;
- Leufkens, Hubert G M
Publication type:
journal article
Randomized controlled trials of COX-2 inhibitors: an analysis of doses used and trends over time to investigate implications for comparative safety.
Published in:
2011
By:
- Stefansdottir G;
- De Bruin ML;
- Knol MJ;
- Grobbee DE;
- Leufkens HG;
- Stefansdottir, Gudrun;
- De Bruin, Marie L;
- Knol, Mirjam J;
- Grobbee, Diederick E;
- Leufkens, Hubert G M
Publication type:
journal article
Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database, VigiBase.
Published in:
2010
By:
- Giezen TJ;
- Mantel-Teeuwisse AK;
- Meyboom RH;
- Straus SM;
- Leufkens HG;
- Egberts TC;
- Giezen, Thijs J;
- Mantel-Teeuwisse, Aukje K;
- Meyboom, Ronald H B;
- Straus, Sabine M J M;
- Leufkens, Hubert G M;
- Egberts, Toine C G
Publication type:
journal article
Safety-related regulatory actions for orphan drugs in the US and EU: a cohort study.
Published in:
2010
By:
- Heemstra HE;
- Giezen TJ;
- Mantel-Teeuwisse AK;
- de Vrueh RL;
- Leufkens HG;
- Heemstra, Harald E;
- Giezen, Thijs J;
- Mantel-Teeuwisse, Aukje K;
- de Vrueh, Remco L A;
- Leufkens, Hubert G M
Publication type:
journal article
Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval.
Published in:
2009
By:
- Giezen TJ;
- Mantel-Teeuwisse AK;
- Straus SM;
- Egberts TC;
- Blackburn S;
- Persson I;
- Leufkens HG;
- Giezen, Thijs J;
- Mantel-Teeuwisse, Aukje K;
- Straus, Sabine M J M;
- Egberts, Toine C G;
- Blackburn, Stella;
- Persson, Ingemar;
- Leufkens, Hubert G M
Publication type:
journal article
Pharmacovigilance of biopharmaceuticals: challenges remain.
Published in:
2009
By:
- Giezen TJ;
- Mantel-Teeuwisse AK;
- Leufkens HG;
- Giezen, Thijs J;
- Mantel-Teeuwisse, Aukje K;
- Leufkens, Hubert G M
Publication type:
journal article
Drug-related nephrotoxic and ototoxic reactions : a link through a predictive mechanistic commonality.
Published in:
2008
By:
- Verdel BM;
- van Puijenbroek EP;
- Souverein PC;
- Leufkens HG;
- Egberts AC;
- Verdel, Bertha Maria;
- van Puijenbroek, Eugène P;
- Souverein, Patrick C;
- Leufkens, Hubert G M;
- Egberts, Antoine C G
Publication type:
journal article
Determinants of headache in lansoprazole users in The Netherlands: results from a nested case-control study.
Published in:
2002
By:
- Claessens, A.A.M.C.;
- Heerdink, E.R.;
- van Eijk, J.T.H.M.;
- Lamers, C.B.H.W.;
- Leufkens, H.G.M.;
- Claessens, Angela A M C;
- Heerdink, Eibert R;
- van Eijk, Jacques T H M;
- Lamers, Cornelis B H W;
- Leufkens, Hubert G M
Publication type:
journal article
Tenofovir-associated renal toxicity in a cohort of HIV infected patients in Ghana.
Published in:
BMC Research Notes, 2019, v. 12, n. 1, p. N.PAG, doi. 10.1186/s13104-019-4454-2
By:
- Nartey, Edmund T.;
- Tetteh, Raymond A.;
- Yankey, Barbara A.;
- Mantel-Teeuwisse, Aukje K.;
- Leufkens, Hubert G. M.;
- Dodoo, Alexander N. O.;
- Lartey, Margaret
Publication type:
Article
Drug development for exceptionally rare metabolic diseases: challenging but not impossible.
Published in:
2013
By:
- Putzeist, Michelle;
- Mantel-Teeuwisse, Aukje K;
- Wied, Christine C Gispen-de;
- Hoes, Arno W;
- Leufkens, Hubert G M;
- de Vrueh, Remco L A
Publication type:
journal article
No difference in between-country variability in use of newly approved orphan and non- orphan medicinal products--a pilot study.
Published in:
2009
By:
- Stolk P;
- Heemstra HE;
- Leufkens HG;
- Bloechl-Daum B;
- Heerdink ER;
- Stolk, Pieter;
- Heemstra, Harald E;
- Leufkens, Hubert G M;
- Bloechl-Daum, Brigitte;
- Heerdink, Eibert R
Publication type:
journal article
Phase I/II Clinical Trial-Based Early Economic Evaluation of Acalabrutinib for Relapsed Chronic Lymphocytic Leukaemia.
Published in:
Applied Health Economics & Health Policy, 2019, v. 17, n. 6, p. 883, doi. 10.1007/s40258-019-00496-1
By:
- Vreman, Rick A.;
- Geenen, Joost W.;
- Hövels, Anke M.;
- Goettsch, Wim G.;
- Leufkens, Hubert G. M.;
- Al, Maiwenn J.
Publication type:
Article
Risk of Aplastic Anemia in Patients Using Antiepileptic Drugs.
Published in:
Epilepsia (Series 4), 2006, v. 47, n. 7, p. 1232, doi. 10.1111/j.1528-1167.2006.00596.x
By:
- Handoko, Kim B.;
- Souverein, Patrick C.;
- van Staa, Tjeerd P.;
- Meyboom, Ronald H. B.;
- Leufkens, Hubert G. M.;
- Egberts, Toine C. G.;
- van den Bemt, Patricia M. L. A.
Publication type:
Article
Impact of medicine shortages on patients - a framework and application in the Netherlands.
Published in:
2022
By:
- Postma, Doerine J.;
- De Smet, Peter A. G. M.;
- Notenboom, Kim;
- Leufkens, Hubert G. M.;
- Mantel-Teeuwisse, Aukje K.
Publication type:
journal article
Impact of medicine shortages on patients - a framework and application in the Netherlands.
Published in:
BMC Health Services Research, 2022, v. 22, n. 1, p. 1, doi. 10.1186/s12913-022-08765-x
By:
- Postma, Doerine J.;
- De Smet, Peter A. G. M.;
- Notenboom, Kim;
- Leufkens, Hubert G. M.;
- Mantel-Teeuwisse, Aukje K.
Publication type:
Article
Remission of Type 2 Diabetes Mellitus in Patients After Different Types of Bariatric Surgery: A Population-Based Cohort Study in the United Kingdom.
Published in:
2015
By:
- Yska, Jan Peter;
- van Roon, Eric N.;
- de Boer, Anthonius;
- Leufkens, Hubert G. M.;
- Wilffert, Bob;
- de Heide, Loek J. M.;
- de Vries, Frank;
- Lalmohamed, Arief
Publication type:
journal article
Adverse events and patients' perceived health-related quality of life at the end of multidrug-resistant tuberculosis treatment in Namibia.
Published in:
Patient Preference & Adherence, 2016, v. 10, p. 2369, doi. 10.2147/PPA.S116860
By:
- Sagwa, Evans L.;
- Ruswa, Nunurai;
- Mavhunga, Farai;
- Rennie, Timothy;
- Leufkens, Hubert G. M.;
- Mantel-Teeuwisse, Aukje K.
Publication type:
Article
Hematocytometry analysis as discriminative marker for asthma phenotypes.
Published in:
Clinical Chemistry & Laboratory Medicine, 2009, v. 47, n. 5, p. 573, doi. 10.1515/CCLM.2009.139
By:
- Velthove, Karin J.;
- van Solinge, Wouter W.;
- Lammers, Jan-Willem J.;
- Leufkens, Hubert G. M.;
- Schweizer, René C.;
- Bracke, Madelon
Publication type:
Article
Angiotensin-converting enzyme (ACE) I/D corrected serum ACE activity and severity assessment of community-acquired pneumonia.
Published in:
Clinical Chemistry & Laboratory Medicine, 2007, v. 45, n. 10, p. 1326, doi. 10.1515/CCLM.2007.268
By:
- van de Garde, Ewoudt M. W.;
- Endeman, Henrik;
- Deneer, Vera H. M.;
- Biesma, Douwe H.;
- Ruven, Henk J. T.;
- van Velzen-Blad, Heleen;
- Leufkens, Hubert G. M.;
- van den Bosch, Jules M. M.
Publication type:
Article
Reimbursement Restriction and Moderate Decrease in Benzodiazepine Use in General Practice.
Published in:
Annals of Family Medicine, 2012, v. 10, n. 1, p. 42, doi. 10.1370/afm.1319
By:
- Hoebert, Joëlle M.;
- Souverein, Patrick C.;
- Mantel-Teeuwisse, Aukje K.;
- Leufkens, Hubert G. M.;
- van Dijk, Liset
Publication type:
Article
Reimbursement restriction and moderate decrease in benzodiazepine use in general practice.
Published in:
2012
By:
- Hoebert JM;
- Souverein PC;
- Mantel-Teeuwisse AK;
- Leufkens HG;
- van Dijk L;
- Hoebert, Joëlle M;
- Souverein, Patrick C;
- Mantel-Teeuwisse, Aukje K;
- Leufkens, Hubert G M;
- van Dijk, Liset
Publication type:
journal article
What Drives Prescribing of Asthma Medication to Children? A Multilevel Population-Based Study.
Published in:
Annals of Family Medicine, 2009, v. 7, n. 1, p. 32, doi. 10.1370/afm.910
By:
- Zuidgeest, Mira G. P.;
- van Dijk, Liset;
- Spreeuwenberg, Peter;
- Smit, Henriëtte A.;
- Brunekreef, Bert;
- Arets, Hubertus G. M.;
- Bracke, Madelon;
- Leufkens, Hubert G. M.
Publication type:
Article
Precision medicine in diabetes and diabetic kidney disease: Regulatory considerations.
Published in:
Diabetes, Obesity & Metabolism, 2018, v. 20, p. 19, doi. 10.1111/dom.13453
By:
- Mol, Peter G. M.;
- Thompson, Aliza;
- Heerspink, Hiddo J. L.;
- Leufkens, Hubert G. M.
Publication type:
Article
Use of incretin agents and risk of acute and chronic pancreatitis: A population-based cohort study.
Published in:
Diabetes, Obesity & Metabolism, 2017, v. 19, n. 3, p. 401, doi. 10.1111/dom.12833
By:
- Knapen, Lotte M.;
- de Jong, Roy G. P. J.;
- Driessen, Johanna H. M.;
- Keulemans, Yolande C.;
- van Erp, Nielka P.;
- De Bruin, Marie L.;
- Leufkens, Hubert G. M.;
- Croes, Sander;
- de Vries, Frank
Publication type:
Article
Long-term use of dipeptidyl peptidase-4 inhibitors and risk of fracture: A retrospective population-based cohort study.
Published in:
Diabetes, Obesity & Metabolism, 2017, v. 19, n. 3, p. 421, doi. 10.1111/dom.12843
By:
- Driessen, Johanna H. M.;
- van den Bergh, Joop P. W.;
- van Onzenoort, Hein A. W.;
- Henry, Ronald M. A.;
- Leufkens, Hubert G. M.;
- de Vries, Frank
Publication type:
Article
Uptake of orphan drugs in the WHO essential medicines lists.
Published in:
Bulletin of the World Health Organization, 2024, v. 102, n. 1, p. 22, doi. 10.2471/BLT.23.289731
By:
- Costa, Enrico;
- Moja, Lorenzo;
- Wirtz, Veronika J.;
- van den Ham, Hendrika A.;
- Huttner, Benedikt;
- Magrini, Nicola;
- Leufkens, Hubert G. M.
Publication type:
Article
Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries.
Published in:
Bulletin of the World Health Organization, 2014, v. 92, n. 9, p. 630, doi. 10.2471/BLT.13.129114
By:
- Leopold, Christine;
- Mantel-Teeuwisse, Aukje K.;
- Vogler, Sabine;
- Valkova, Silvia;
- de Joncheere, Kees;
- Leufkens, Hubert G. M.;
- Wagner, Anita K.;
- Ross-Degnan, Dennis;
- Laing, Richard
Publication type:
Article
"Rare essentials": drugs for rare diseases as essential medicines.
Published in:
Bulletin of the World Health Organization, 2006, v. 84, n. 9, p. 745, doi. 10.2471/BLT.06.031518
By:
- Stolk, Pieter;
- Willemen, Marjolein J. C.;
- Leufkens, Hubert G. M.
Publication type:
Article
The Epidemiology of Hip and Major Osteoporotic Fractures in a Dutch Population of Community-Dwelling Elderly: Implications for the Dutch FRAX® Algorithm.
Published in:
PLoS ONE, 2015, v. 10, n. 12, p. 1, doi. 10.1371/journal.pone.0143800
By:
- Klop, Corinne;
- Welsing, Paco M. J.;
- Leufkens, Hubert G. M.;
- Elders, Petra J. M.;
- Overbeek, Jetty A.;
- van den Bergh, Joop P.;
- Bijlsma, Johannes W. J.;
- de Vries, Frank
Publication type:
Article
Selection of Essential Medicines for Diabetes in Low and Middle Income Countries: A Survey of 32 National Essential Medicines Lists.
Published in:
PLoS ONE, 2014, v. 9, n. 9, p. 1, doi. 10.1371/journal.pone.0106072
By:
- Bazargani, Yaser T.;
- de Boer, Anthonius;
- Leufkens, Hubert G. M.;
- Mantel-Teeuwisse, Aukje K.
Publication type:
Article
Essential Medicines Are More Available than Other Medicines around the Globe.
Published in:
PLoS ONE, 2014, v. 9, n. 2, p. 1, doi. 10.1371/journal.pone.0087576
By:
- Bazargani, Yaser T.;
- Ewen, Margaret;
- de Boer, Anthonius;
- Leufkens, Hubert G. M.;
- Mantel-Teeuwisse, Aukje K.
Publication type:
Article
Impact of Over-the-Counter Restrictions on Antibiotic Consumption in Brazil and Mexico.
Published in:
PLoS ONE, 2013, v. 8, n. 10, p. 1, doi. 10.1371/journal.pone.0075550
By:
- Santa-Ana-Tellez, Yared;
- Mantel-Teeuwisse, Aukje K.;
- Dreser, Anahi;
- Leufkens, Hubert G. M.;
- Wirtz, Veronika J.
Publication type:
Article
The Views of Healthcare Professionals, Drug Developers and Regulators on Information about Older People Needed for Rational Drug Prescription.
Published in:
PLoS ONE, 2013, v. 8, n. 8, p. 1, doi. 10.1371/journal.pone.0072060
By:
- Beers, Erna;
- Egberts, Toine C. G.;
- Leufkens, Hubert G. M.;
- Jansen, Paul A. F.
Publication type:
Article
Risk of Death and Cardiovascular Outcomes with Thiazolidinediones: A Study with the General Practice Research Database and Secondary Care Data.
Published in:
PLoS ONE, 2011, v. 6, n. 12, p. 1, doi. 10.1371/journal.pone.0028157
By:
- Gallagher, Arlene M.;
- Smeeth, Liam;
- Seabroke, Suzie;
- Leufkens, Hubert G. M.;
- van Staa, Tjeerd P.
Publication type:
Article
Regulatory, health technology assessment and company interactions: the current landscape and future ecosystem for drug development, review and reimbursement.
Published in:
International Journal of Technology Assessment in Health Care, 2023, v. 39, n. 1, p. 1, doi. 10.1017/S0266462323000144
By:
- Ting Wang;
- McAuslane, Neil;
- Goettsch, Wim G.;
- Leufkens, Hubert G. M.;
- De Bruin, Marie L.
Publication type:
Article
Addressing uncertainty in relative effectiveness assessments by HTA organizations.
Published in:
International Journal of Technology Assessment in Health Care, 2022, v. 38, n. 1, p. 1, doi. 10.1017/S026646232100177X
By:
- Vreman, Rick A.;
- Strigkos, George;
- Leufkens, Hubert G. M.;
- Schünemann, Holger J.;
- Mantel-Teeuwisse, Aukje K.;
- Goettsch, Wim G.
Publication type:
Article
Addressing uncertainty in relative effectiveness assessments by HTA organizations.
Published in:
International Journal of Technology Assessment in Health Care, 2021, v. 38, n. 1, p. 1, doi. 10.1017/S026646232100177X
By:
- Vreman, Rick A.;
- Strigkos, George;
- Leufkens, Hubert G. M.;
- Schünemann, Holger J.;
- Mantel-Teeuwisse, Aukje K.;
- Goettsch, Wim G.
Publication type:
Article
Getting the Right Evidence After Drug Approval.
Published in:
Frontiers in Pharmacology, 2020, v. 11, p. N.PAG, doi. 10.3389/fphar.2020.569535
By:
- Vreman, Rick A.;
- Leufkens, Hubert G. M.;
- Kesselheim, Aaron S.
Publication type:
Article
Pre‐approval and post‐approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: A comparison with standard approved cancer drugs.
Published in:
British Journal of Clinical Pharmacology, 2022, v. 88, n. 5, p. 2169, doi. 10.1111/bcp.15141
By:
- Bloem, Lourens T.;
- Bot, Rosa E.;
- Mantel‐Teeuwisse, Aukje K.;
- van der Elst, Menno E.;
- Sonke, Gabe S.;
- Klungel, Olaf H.;
- Leufkens, Hubert G. M.;
- Hoekman, Jarno
Publication type:
Article
Post‐marketing dosing changes in the label of biologicals.
Published in:
British Journal of Clinical Pharmacology, 2019, v. 85, n. 4, p. 715, doi. 10.1111/bcp.13843
By:
- Minnema, Lotte A.;
- Giezen, Thijs J.;
- Gardarsdottir, Helga;
- Egberts, Toine C. G.;
- Leufkens, Hubert G. M.;
- Mantel‐Teeuwisse, Aukje K.
Publication type:
Article
Comparing safety information of biosimilars with their originators: a cross‐sectional analysis of European risk management plans.
Published in:
British Journal of Clinical Pharmacology, 2018, v. 84, n. 4, p. 738, doi. 10.1111/bcp.13454
By:
- Lepelaars, Leroy R. A.;
- Renda, Francesca;
- Pani, Luca;
- Pimpinella, Giuseppe;
- Leufkens, Hubert G. M.;
- Trifirò, Gianluca;
- Tafuri, Giovanni;
- Mantel‐Teeuwisse, Aukje K.;
- Trotta, Francesco
Publication type:
Article
Pharmacological vs. classical approaches in the design of first in man clinical drug trials.
Published in:
British Journal of Clinical Pharmacology, 2017, v. 83, n. 12, p. 2807, doi. 10.1111/bcp.13422
By:
- Bogert, Cornelis A.;
- Cohen, Adam F.;
- Leufkens, Hubert G. M.;
- Gerven, Joop M. A.
Publication type:
Article

Found: 134