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Items: 1 to 50 of 60

1.

Factors Contributing to the Efficacy-Effectiveness Gap in the Case of Orphan Drugs for Metabolic Diseases.

Schuller Y, Hollak CEM, Gispen-de Wied CC, Stoyanova-Beninska V, Biegstraaten M.

Drugs. 2017 Sep;77(13):1461-1472. doi: 10.1007/s40265-017-0788-z.

2.

Early Nonresponse in the Antipsychotic Treatment of Acute Mania: A Criterion for Reconsidering Treatment? Results From an Individual Patient Data Meta-Analysis.

Welten CC, Koeter MW, Wohlfarth TD, Storosum JG, van den Brink W, Gispen-de Wied CC, Leufkens HG, Denys DA.

J Clin Psychiatry. 2016 Sep;77(9):e1117-e1123. doi: 10.4088/JCP.15r10051.

PMID:
27780320
3.

Does Insight Affect the Efficacy of Antipsychotics in Acute Mania?: An Individual Patient Data Regression Meta-Analysis.

Welten CC, Koeter MW, Wohlfarth TD, Storosum JG, van den Brink W, Gispen-de Wied CC, Leufkens HG, Denys DA.

J Clin Psychopharmacol. 2016 Feb;36(1):71-6. doi: 10.1097/JCP.0000000000000435.

PMID:
26647231
4.

Net gain analysis, an addition to responder analysis--The case of antipsychotic treatment of acute mania.

Welten CC, Koeter MW, Wohlfarth TD, Storosum JG, van den Brink W, Gispen-de Wied CC, Leufkens HG, Denys DA.

Regul Toxicol Pharmacol. 2015 Oct;73(1):227-31. doi: 10.1016/j.yrtph.2015.06.020. Epub 2015 Jul 8.

PMID:
26164267
5.

Efficacy of drug treatment for acute mania differs across geographic regions: An individual patient data meta-analysis of placebo-controlled studies.

Welten CC, Koeter MW, Wohlfarth TD, Storosum JG, van den Brink W, Gispen-de Wied CC, Leufkens HG, Denys DA.

J Psychopharmacol. 2015 Aug;29(8):923-32. doi: 10.1177/0269881115586938. Epub 2015 Jun 2.

PMID:
26038109
6.

Placebo response in antipsychotic trials of patients with acute mania: Results of an individual patient data meta-analysis.

Welten CC, Koeter MW, Wohlfarth T, Storosum JG, van den Brink W, Gispen-de Wied CC, Leufkens HG, Denys DA.

Eur Neuropsychopharmacol. 2015 Jul;25(7):1018-26. doi: 10.1016/j.euroneuro.2015.03.010. Epub 2015 Mar 30.

PMID:
25907248
7.

Contribution of animal studies to evaluate the similarity of biosimilars to reference products.

van Meer PJ, Ebbers HC, Kooijman M, Gispen-de Wied CC, Silva-Lima B, Moors EH, Schellekens H.

Drug Discov Today. 2015 Apr;20(4):483-90. doi: 10.1016/j.drudis.2014.11.009. Epub 2014 Nov 20. Review.

PMID:
25463036
8.

Regulatory scientific advice on non-inferiority drug trials.

Wangge G, Putzeist M, Knol MJ, Klungel OH, Gispen-De Wied CC, de Boer A, Hoes AW, Leufkens HG, Mantel-Teeuwisse AK.

PLoS One. 2013 Sep 5;8(9):e74818. doi: 10.1371/journal.pone.0074818. eCollection 2013.

9.

The risk-based approach to ATMP development - generally accepted by regulators but infrequently used by companies.

Kooijman M, van Meer PJ, Gispen-de Wied CC, Moors EH, Hekkert MP, Schellekens H.

Regul Toxicol Pharmacol. 2013 Nov;67(2):221-5. doi: 10.1016/j.yrtph.2013.07.014. Epub 2013 Aug 7.

PMID:
23933031
10.

Immunogenicity of mAbs in non-human primates during nonclinical safety assessment.

van Meer PJ, Kooijman M, Brinks V, Gispen-de Wied CC, Silva-Lima B, Moors EH, Schellekens H.

MAbs. 2013 Sep-Oct;5(5):810-6. doi: 10.4161/mabs.25234. Epub 2013 Jun 6.

11.

From molecule to market access: drug regulatory science as an upcoming discipline.

Gispen-de Wied CC, Leufkens HG.

Eur J Pharmacol. 2013 Nov 5;719(1-3):9-15. doi: 10.1016/j.ejphar.2013.07.021. Epub 2013 Jul 24. Review.

PMID:
23891846
12.

EU marketing authorization review of orphan and non-orphan drugs does not differ.

Putzeist M, Mantel-Teeuwisse AK, Llinares J, Gispen-De Wied CC, Hoes AW, Leufkens HG.

Drug Discov Today. 2013 Oct;18(19-20):1001-6. doi: 10.1016/j.drudis.2013.06.012. Epub 2013 Jul 5. Review.

PMID:
23835230
13.

Cognition in schizophrenia: summary Nice Consultation Meeting 2012.

Nutt D, Gispen-de Wied CC, Arango C, Keefe RS, Penad├ęs R, Murphy DG, Robbins TW, Sahakian BJ.

Eur Neuropsychopharmacol. 2013 Aug;23(8):769-78. doi: 10.1016/j.euroneuro.2013.03.005. Epub 2013 May 15. No abstract available.

PMID:
23684476
14.

Factors influencing non-approval of new drugs in Europe.

Putzeist M, Mantel-Teeuwisse AK, Aronsson B, Rowland M, Gispen-de Wied CC, Vamvakas S, Hoes AW, Leufkens HG, Eichler HG.

Nat Rev Drug Discov. 2012 Dec;11(12):903-4. doi: 10.1038/nrd3894. No abstract available.

PMID:
23197028
15.

The ability of animal studies to detect serious post marketing adverse events is limited.

van Meer PJ, Kooijman M, Gispen-de Wied CC, Moors EH, Schellekens H.

Regul Toxicol Pharmacol. 2012 Dec;64(3):345-9. doi: 10.1016/j.yrtph.2012.09.002. Epub 2012 Sep 12.

PMID:
22982732
16.

Prescriptive contraceptive use among isotretinoin users in the Netherlands in comparison with non-users: a drug utilisation study.

Crijns HJ, van Rein N, Gispen-de Wied CC, Straus SM, de Jong-van den Berg LT.

Pharmacoepidemiol Drug Saf. 2012 Oct;21(10):1060-6. doi: 10.1002/pds.3200. Epub 2012 Jan 6.

PMID:
22228673
17.

Determinants for successful marketing authorisation of orphan medicinal products in the EU.

Putzeist M, Heemstra HE, Garcia JL, Mantel-Teeuwisse AK, Gispen-De Wied CC, Hoes AW, Leufkens HG.

Drug Discov Today. 2012 Apr;17(7-8):352-8. doi: 10.1016/j.drudis.2011.10.027. Epub 2011 Nov 7. Review.

PMID:
22094244
18.

Prevention trials in Alzheimer's disease: an EU-US task force report.

Vellas B, Aisen PS, Sampaio C, Carrillo M, Scheltens P, Scherrer B, Frisoni GB, Weiner M, Schneider L, Gauthier S, Gispen-de Wied CC, Hendrix S, Feldman H, Cedarbaum J, Petersen R, Siemers E, Andrieu S, Prvulovic D, Touchon J, Hampel H.

Prog Neurobiol. 2011 Dec;95(4):594-600. doi: 10.1016/j.pneurobio.2011.08.014. Epub 2011 Sep 10.

PMID:
21925234
19.

The distribution of congenital anomalies within the VACTERL association among tumor necrosis factor antagonist-exposed pregnancies is similar to the general population.

Crijns HJ, Jentink J, Garne E, Gispen-de Wied CC, Straus SM, de Jong-van den Berg LT; EUROCAT Working Group.

J Rheumatol. 2011 Sep;38(9):1871-4. doi: 10.3899/jrheum.101316. Epub 2011 Jul 1.

PMID:
21724702
20.

Interchangeability of generic anti-epileptic drugs: a quantitative analysis of topiramate and gabapentin.

Maliepaard M, Banishki N, Gispen-de Wied CC, Teerenstra S, Elferink AJ.

Eur J Clin Pharmacol. 2011 Oct;67(10):1007-16. doi: 10.1007/s00228-011-1041-4. Epub 2011 Apr 15.

PMID:
21494766
21.

Regulatory scientific advice in drug development: does company size make a difference?

Putzeist M, Mantel-Teeuwisse AK, Gispen-De Wied CC, Hoes AW, Leufkens HG.

Eur J Clin Pharmacol. 2011 Feb;67(2):157-64. doi: 10.1007/s00228-010-0919-x. Epub 2010 Nov 4.

22.

Impaired neuroendocrine and immune response to acute stress in medication-naive patients with a first episode of psychosis.

van Venrooij JA, Fluitman SB, Lijmer JG, Kavelaars A, Heijnen CJ, Westenberg HG, Kahn RS, Gispen-de Wied CC.

Schizophr Bull. 2012 Mar;38(2):272-9. doi: 10.1093/schbul/sbq062. Epub 2010 Jun 17.

23.

Requirements for generic anti-epileptic medicines: a regulatory perspective.

Maliepaard M, Hekster YA, Kappelle A, van Puijenbroek EP, Elferink AJ, Welink J, Gispen-de Wied CC, Lekkerkerker FJ.

J Neurol. 2009 Dec;256(12):1966-71. doi: 10.1007/s00415-009-5231-2. Epub 2009 Jul 15. Review. No abstract available.

24.
25.

Haloperidol counteracts the ketamine-induced disruption of processing negativity, but not that of the P300 amplitude.

Oranje B, Gispen-de Wied CC, Westenberg HG, Kemner C, Verbaten MN, Kahn RS.

Int J Neuropsychopharmacol. 2009 Jul;12(6):823-32. doi: 10.1017/S1461145708009814. Epub 2009 Jan 21.

PMID:
19154656
26.

Blunting of the cardiovascular effect of aspirin by ibuprofen: what is the evidence?

van Westrhenen R, Gispen-de Wied CC, Lekkerkerker JF.

Clin Pharmacol Ther. 2008 Jun;83(6):812; author reply 812-3. No abstract available.

PMID:
18043688
27.

Autonomic and neuroendocrine responses to a psychosocial stressor in adults with autistic spectrum disorder.

Jansen LM, Gispen-de Wied CC, Wiegant VM, Westenberg HG, Lahuis BE, van Engeland H.

J Autism Dev Disord. 2006 Oct;36(7):891-9.

PMID:
16865550
28.

Hyperglycemia and diabetes in patients with schizophrenia or schizoaffective disorders.

Cohen D, Stolk RP, Grobbee DE, Gispen-de Wied CC.

Diabetes Care. 2006 Apr;29(4):786-91.

PMID:
16567816
29.

No effects of l-dopa and bromocriptine on psychophysiological parameters of human selective attention.

Oranje B, Gispen-de Wied CC, Westenberg HG, Kemner C, Verbaten MN, Kahn RS.

J Psychopharmacol. 2006 Nov;20(6):789-98. Epub 2006 Feb 14.

PMID:
16478755
30.

Antidepressants use in children and adolescents and the risk of suicide.

Wohlfarth TD, van Zwieten BJ, Lekkerkerker FJ, Gispen-de Wied CC, Ruis JR, Elferink AJ, Storosum JG.

Eur Neuropsychopharmacol. 2006 Feb;16(2):79-83. Epub 2005 Nov 18.

PMID:
16298514
31.

Prevalence of diabetes mellitus in chronic schizophrenic inpatients in relation to long-term antipsychotic treatment.

Cohen D, Dekker JJ, Peen J, Gispen-de Wied CC.

Eur Neuropsychopharmacol. 2006 Apr;16(3):187-94. Epub 2005 Nov 2.

PMID:
16263247
32.

Immunological characteristics of diabetes in schizophrenia.

Cohen D, Batstra MR, Gispen-de Wied CC.

Diabetologia. 2005 Sep;48(9):1941-2. Epub 2005 Jul 29. No abstract available.

PMID:
16052326
33.

Suicide risk in placebo-controlled trials of treatment for acute manic episode and prevention of manic-depressive episode.

Storosum JG, Wohlfarth T, Gispen-de Wied CC, Linszen DH, Gersons BP, van Zwieten BJ, van den Brink W.

Am J Psychiatry. 2005 Apr;162(4):799-802.

PMID:
15800158
34.

Increasing dopaminergic activity: effects of L-dopa and bromocriptine on human sensory gating.

Oranje B, Gispen-de Wied CC, Westenberg HG, Kemner C, Verbaten MN, Kahn RS.

J Psychopharmacol. 2004 Sep;18(3):388-94.

PMID:
15358983
35.

How real are patients in placebo-controlled studies of acute manic episode?

Storosum JG, Fouwels A, Gispen-de Wied CC, Wohlfarth T, van Zwieten BJ, van den Brink W.

Eur Neuropsychopharmacol. 2004 Aug;14(4):319-23.

PMID:
15163442
36.

Attenuated stress responsiveness in an animal model for neurodevelopmental psychopathological disorders.

Terpstra J, Gispen-De Wied CC, Broekhoven MH, Frankhuijzen AC, Kahn RS, van Ree JM, Wiegant VM.

Eur Neuropsychopharmacol. 2003 Aug;13(4):249-56.

PMID:
12888184
37.

[Schizophrenia and diabetes mellitus: not an improbable combination].

Cohen D, Gispen-de Wied CC.

Ned Tijdschr Geneeskd. 2003 May 24;147(21):993-6. Dutch.

PMID:
12811967
38.

Differentiation between autism and multiple complex developmental disorder in response to psychosocial stress.

Jansen LM, Gispen-de Wied CC, van der Gaag RJ, van Engeland H.

Neuropsychopharmacology. 2003 Mar;28(3):582-90. Epub 2002 Aug 6.

39.

Modulating sensory gating in healthy volunteers: the effects of ketamine and haloperidol.

Oranje B, Gispen-de Wied CC, Verbaten MN, Kahn RS.

Biol Psychiatry. 2002 Nov 1;52(9):887-95.

PMID:
12399142
40.

Effects of typical and atypical antipsychotics on the prepulse inhibition of the startle reflex in patients with schizophrenia.

Oranje B, Van Oel CJ, Gispen-De Wied CC, Verbaten MN, Kahn RS.

J Clin Psychopharmacol. 2002 Aug;22(4):359-65.

PMID:
12172334
41.

Effect of olanzapine on glutamate levels in cerebrospinal fluid of patients with schizophrenia.

Scheepers FE, Gispen-De Wied CC, Westenberg HG, Kahn RS.

J Clin Psychopharmacol. 2002 Jun;22(3):333-4. No abstract available.

PMID:
12006906
42.

The stress-vulnerability hypothesis in psychotic disorders: focus on the stress response systems.

Gispen-de Wied CC, Jansen LM.

Curr Psychiatry Rep. 2002 Jun;4(3):166-70. Review.

PMID:
12003677
43.

The effect of olanzapine treatment on monoamine metabolite concentrations in the cerebrospinal fluid of schizophrenic patients.

Scheepers FE, Gispen-de Wied CC, Westenberg HG, Kahn RS.

Neuropsychopharmacology. 2001 Oct;25(4):468-75.

44.

Effect of clozapine on caudate nucleus volume in relation to symptoms of schizophrenia.

Scheepers FE, Gispen de Wied CC, Hulshoff Pol HE, Kahn RS.

Am J Psychiatry. 2001 Apr;158(4):644-6.

PMID:
11282704
45.

Stress in schizophrenia: an integrative view.

Gispen-de Wied CC.

Eur J Pharmacol. 2000 Sep 29;405(1-3):375-84. Review.

PMID:
11033342
46.

Commentary on plasma levels of homovanillic acid (phVA) under influence of mental stress.

Oranje B, Bijl S, Campagne A, Gispen-de Wied CC.

Neuropsychopharmacology. 2000 Sep;23(3):345-6. No abstract available.

47.

Unresponsiveness to psychosocial stress in a subgroup of autistic-like children, multiple complex developmental disorder.

Jansen LM, Gispen-de Wied CC, Van der Gaag RJ, ten Hove F, Willemsen-Swinkels SW, Harteveld E, Van Engeland H.

Psychoneuroendocrinology. 2000 Nov;25(8):753-64.

PMID:
10996471
48.

Prenatal exposure to famine and brain morphology in schizophrenia.

Hulshoff Pol HE, Hoek HW, Susser E, Brown AS, Dingemans A, Schnack HG, van Haren NE, Pereira Ramos LM, Gispen-de Wied CC, Kahn RS.

Am J Psychiatry. 2000 Jul;157(7):1170-2.

PMID:
10873931
49.

Selective impairments in the stress response in schizophrenic patients.

Jansen LM, Gispen-de Wied CC, Kahn RS.

Psychopharmacology (Berl). 2000 Apr;149(3):319-25.

PMID:
10823414
50.

Pituitary-adrenal function in adolescent psychiatric patients: impact of depressive symptoms.

Gispen-de Wied CC, Jansen LM, Duyx JH, Thijssen JH, van Engeland H.

J Affect Disord. 2000 Jul;59(1):71-6.

PMID:
10814774

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