Publications

2015

Pharmacokinetic Drug Intraction Studies with Enzalutamide

Jacqueline A. Gibbons, Michiel de Vries, Walter Krauwinkel, Yoshiaki Ohtsu, Jan Noukens, Jan-Stefan van der Walt, Roelof Mol, Joyce Mordenti, Taoufik Ouatas

2014

A preliminary population pharmacokinetic model for dose selection of treosulfan used in conditioning treatment prior to haematopoietic stem cell transplantation (HSCT) in children

Paul J. Van Den Berg, Martijn Ruppert, Karl-Walter Sykora, Rita Beier, Dietrich W. Beelen, Ralf A. Hilger, Max E. Scheulen, Jacek Wachowiak, Eneida R. Nemecek, Edwin Spaans, Michael Lioznov, Uwe Pichlmeier, Beate Wulff, Joachim Baumgart (EBMT, Milano, Italy, 2014)

2014

Whole-Body PBPK Modeling of Tacrolimus in Healthy Volunteers

S. Zeiser, N. Treijtel, E. Spaans (PAGE, Allicante, Spain 2014)

2013

Randomized Phase I: Safety, Immunogenicity and Mucosal Antiviral Activity in Young Healthy Women Vaccinated with HIV-1 Gp41 P1 Peptide on Virosomes

Leroux-Roels G, Maes C, Clement F, van Engelenburg F, van den Dobbelsteen M, Adler M, Amacker M, Lopalco L, Bomsel M, Chalifour A, Fleury S (PLoS One.;8(2):e55438, 2013)

2012

Validation of an in Vivo Phenotyping Cocktail for the Early Detection of Inductive or Inhibitory Potential of New Drugs

L. De Bock, N. Treijtel, K. Boussery, J. van Bocxlaer, L. van Bortel, K. Bol, P. Peeters and E. Spaans (ISSX Meeting, Noordwijk aan Zee, The Netherlands, 2012)

2012

Evaluating Dosing Regimens of a Hepatitis C NS3 Inhibitor using PK/PD Modeling

M. Ruppert, K. Bol, R. Hooijmaijers, E. Olek, N. Treijtel, E. Spaans (ISSX Meeting, Noordwijk aan Zee, The Netherlands, 2012)

2012

Population PK Modeling of Dapivirine Released from Vaginal Rings

S. Zeiser, W. Hettema, K. Bol, P. van den Berg, A. Nel, J. Nuttall, E. Spaans (PAGE, Venice, Italy, 2012)

2011

Pharmacokinetics (PK) and Pharmacodynamics (PD) of a New Direct Thrombin Inhibitor (DPOC-4088) After Single Oral Doses of Two Prolonged Release Formulations in Healthy Male Subjects (NCT01347203)

Luc M. Van Bortel, Griet Van Lancker, Henri Vanden Bavière, Willem Hettema, Edwin Spaans, Sankar Ramakrishnan, Venkatesan Elumalai, Suryakumar Jayanthi, Stephane E. Allard (ASH, San Diego, CA, USA, 2011)

2011

Interaction of Pipamperone, Citalopram, and Genetic Variables in the Prediction of Antidepressant Response.

A. Schatzberg, E. Binder, C. Nemeroff, T. Schlaepfer, K. Bol, L. Haazen, D. De Chaffoy, E. Buntinx. (ECNP, Paris, 2011)

2011

Phase III Dose Selection for PNB01, a Novel Fixed-Dose Combination Antidepressant Inducing a Faster and Sustained Response

E. Buntinx, K. Bol, P. Van den Berg, L. Haazen, R. Van den Broek and D. de Chaffoy. (ECNP, Paris, 2011)

2011

Population PK/PD Modeling of a Hepatitis C NS3 Inhibitor

M. Ruppert, K. Bol, R. Hooijmaijers, E. Olek, N. Treijtel, E. Spaans. PAGE meeting (Athens, Greece, 2011)

2011

458 Final results of the pharmacokinetics, efficacy, and safety/tolerability of 400 and 600 mg once-daily dosing of ACH-1625 (HCV NS3 protease inhibitor) in HCV genotype 1

V. Detishin, W. Haazen, R. Hooijmaijers, M. Ruppert, K. Bol, H. Robison, L. Robarge, A. Agarwal, M. Deshpande, E. Ole

2010

Pharmacokinetic Sub-Study in the SPIRIT III Randomized and Controlled Trial of XIENCE V Everolimus Eluting Coronary Stent System

Wang Q, Pierson W, Sood P, Bol C, Cannon L, Gordon P, Saucedo J, Sudhir K.

2010

How to Assess the Speed of Antidepressant Effect: Insights From the PIPCIT Clinical Trial Program

E. Buntinx, K. Bol, L. Haazen, M. Thase. (New Research Approaches for Mental Health Interventions, Boca Raton, USA, 2010)

2010

Interaction of Pipamperone Augmentation of Citalopram and Genetic Variables in the Prediction of Antidepressant Response.

E. Binder, C. Nemeroff, A.Schatzberg, T. Schlaepfer, K.Bol, L. Haazen, D. De Chaffoy, E. Buntinx. (ACNP 49th Annual Meeting, Miami Beach, USA, 2010)

2010

Low dose Pipamperone, effective to enhance antidepressant effect of citalopram, occupies 5HT2A receptor for only 50-60% while leaving D2 receptor nearly drug free: a PET study

E. Buntinx, K. Bol, P. Van den Berg, E. Spaans, L. Haazen. (23rd ECNP Congress, Amsterdam, The Netherlands, 2010)

2010

Selective Serotonergic Properties of Low-Dose Pipamperone May Enhance Antidepressant Effect: Preclinical Evidence

E. Buntinx, K. Bol, A. Megens, T. Schlaepfer. (Society of Biological Psychiatry 65th Annual Meeting, New Orleans, USA, 2010)

2010

Accelerated antidepressant effect of Pipamperone characterized by non-linear mixed effect model using a mixture model to differentiate between responders and non-responders

K. Bol, P. Van den Berg, R. Hooijmaijers, L. Haazen, E. Buntinx. (6th International Symposium on Measurement and Kinetics of in vivo Drug Effects, Noordwijkerhout, The Netherlands, 2010)

2010

Formulation Development of Therapeutic Proteins

Hanns-Christian Mahler, Albert Mekking (Protein Pharmaceuticals (ECV), Chapter 5, pp 144-162, 2010)

2009

JNJ-26481585, a novel "second-generation" oral histone deacetylase inhibitor, shows broad-spectrum preclinical antitumoral activity

Arts J, King P, Mariën A, Floren W, Beliën A, Janssen L, Pilatte I, Roux B, Decrane L, Gilissen R, Hickson I, Vreys V, Cox E, Bol K, Talloen W, Goris I, Andries L, Du Jardin M, Janicot M, Page M, van Emelen K, Angibaud (P. Clin Cancer Res. 15(22):6841-51, 2009)

2009

Preclinical and clinical pharmacodynamic activity of JNJ-26854165: A novel hdm2 antagonist in clinical development

J. Arts, K. Smans, L. Andries, W. Floren, P. King, L. Van Nuffel, I. Goris, H. Göhlmann, B. Rooney, P. Palmer, L. De Bie, K. Bol, S, Kraljevic, S. Hong Zhuang, M. Page, J. Tabernero, J. Baselga, L. Dirix, P. Schöffski, H. Winkler. (100th AACR Annual Meeting, Denver, USA, 2009)

2009

Herbal products: marketing strategies and legislation

P. Hooyenga, R.F. Witkamp, K. Groen (International Journal of Green Pharmacy; 3:270-6, 2009)

2008

Systemic exposure of everolimus after stent implantation: a pharmacokinetic study

Marcus Wiemer, Ashok Seth, Praveen Chandra, Jörg Neuzner, Gert Richardt, Jan J Piek, Martin Desaga, Carlos Macaya, Cornelis J Bol, Karine Miquel-Hebert, Karolien De Roeck, Patrick W Serruys. (Am Heart J, 156, 751.e1-7, 2008)

2008

Once-daily regimens of the HCV NS3/4A-Protease inhibitor TMC435350 are predicted to provide therapeutic exposure in plasma and liver

G. Van't Klooster, I. Vanwelkenhuysen, R. Hooijmaijers, K. Bol, M. Voets, J. Van Houdt, R. Verloes, F. Aharchi, K. Marien, P. Van Remoortere, F. Broeckaert, H. De Kock, K. Simmen. (43rd Annual Meeting of the EASL, Milan, Italy, 2008)

2008

First-in-Human Study of the First-in-Class Hdm2 Inhibitor JNJ-26854165

J. Tabernero, P. Schöffsky, L.Dirix, J. Capdevila, H. Dumez, S. Kraljevic, K. Bol, H. Winkler, L. De Bie, B. Rooney, J. Arts, E. Leo. (20th EORTC-NCI-AACR symposium on Molecular targets and Cancer Therapeutics, Geneva, Switzerland, 2008)

2004

Pharmacokinetics and effect of food on TMC114, a potent next generation protease inhibitor, boosted with low-dose ritonavir

Hoetelmans R, Lefebvre E, van der Sandt I, et al. (Fifth International Workshop on Clinical Pharmacology of HIV Therapy, Rome, 2004)

2003

A Randomized, Double-Blind, Placebo-Controlled Trial in Antiretroviral Naïve, HIV-1 Infected Subjects with TMC125 As 7-Day Monotherapy

B. Gruzdez, A. Rakhmanova, E. Doubovskaya, A. Yakovlev, M. Peeters, A. Rinehart, K. De Dier, P. Baede-van Dijk, W. Parys, G. van ’t Klooster (AIDS 2003;17: 2487-94)

2003

TMC114, a next generation HIV protease inhibitor: pharmacokinetics and safety following oral administration of multiple doses with and without low doses of ritonavir in healthy volunteers

Hoetelmans R, Van der Sandt I, De Pauw M, Struble K, Peeters M, Van der Geest R. (10th CROI, Boston, MA, USA, 2003)

2003

First clinical results on antiretroviral activity, pharmacokinetics, and safety of TMC114, an HIV-1 protease inhibitor, in multiple PI-experienced patients

Arasteh, K., A. Clumeck, H. Pozniak, H. Jäger, M. De Pauw, H. Müller, M. Peeters, R. Hoetelmans, S. De Meyer, I. Van der Sandt, S. Comhaire, and R. Van der Geest. (10th CROI, Boston, MA, USA, 2003)

2003

TMC125, A Next Generation NNRTI: Pharmacokinetics and Safety Following Oral Administration of Multiple Doses in Antiretroviral Naive HIV-1 Infected Patients

R. Hoetelmans, P. Baede-van Dijk, B. Gruzdev, A. Rakhmanova, E. Doubovskaya, A. Yakovlev, M. Peeters, K. De Dier, K. Struble, and Gerben van ’t Klooster. (4th Int. Workshop on Clinical Pharmacology of HIV Therapy. Cannes, France, 2003)

2002

Pharmacokinetics of TMC125 in HIV-Infected Patients and Healthy Volunteers

S. Piscitelli, P. Baede, K. DeDier, G. Van’t Klooster, N. Graham. (3rd International Workshop on Clinical Pharmacology of HIV Therapy, 2002)

2002

Drug Interactions with TMC125, a Potent Next Generation NNRTI

P. Baede, S. Piscitelli, N. Graham, G. Van’t Klooster (42nd ICAAC in San Diego, CA, USA, 2002)

2002

TMC125 does not Alter Lopinavir/Ritonavir Pharmacokinetics in Healthy Volunteers

S. C. Piscitelli, P. Baede,G. Van't Klooster, N. Graham (42nd ICAAC in San Diego, CA, USA, 2002)

2002

The integration of resistance test technologies with plasma level determination technologies

K. Groen and K. Hertogs (British HIV Association, London, UK, 2002)

2001

TMC125 is a Highly Potent Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) in Antiretroviral Therapy (ART)-Naïve, HIV-1 Infected Subjects

B. Gruzdev, A. Rakhmanova, K. De Dier, S. Comhaire, P. Baede-van Dijk, G. Van t Klooster. (41st ICAAC, Chicago, Illinois, 2001)

2001

Safety, tolerability and pharmacokinetics of escalating single oral doses of TMC114, a novel protease inhibitor (PI) highly active against HIV-1 variants resistant to other PIs

Van der Geest R, van der Sandt I, Gille D, Groen K, Titsmans L, Stoffels P. (41st ICAAC, Chicago, Illinois, 2001)

2001

One week of monotherapy with TMC125, a novel highly potent NNRTI, produces a mean 2-log reduction in viral load in antiretroviral-naive, HIV-1 infected volunteers

B. Gruzdev, A. Rakhmanova, G. van 't Klooster, K. De Dier, S. Comhaire, P. Baede-Van Dijk, M.P. de Béthune, and R. Pauwels (8th ECCATHI, Athens, Greece, 2001)

2000

Synergism of resistance testing and therapeutic drug monitoring in the optimization of HIV-1 therapy

K. Groen, V. Piotrovskij, S. Wegner, R. Harrigan, B. Larder, W. Verbiest, K. Hertogs and P. Stoffels (ACTG, San Diego, USA, 2000)

1999

The potential role of resistance testing and therapeutic drug monitoring in the optimization of antiretroviral drug therapy

S. Wegner, K. Groen, N. Aronson, A. Barile, W. Emmons, K. Stephan, S. Tasker, P. Stoffels, W. Verbiest, V. Piotrovsky, B. Larder, K. Hertogs (Drug Resistance, San Diego, USA, 1999)

1998

Drug interactions with itraconazole, fluconazole and terbinafine, and their management

Gupta AK, Del Rosso JQ, Rosen T, Groen K, De Doncker P. (56th Annu Meet Am Acad Dermatol, Orlando, FL, USA, 1998)

1997

Tolerability and safety of itraconazole in diabetics

Verspeelt J, De Doncker P, Groen K, Marynissen G, Stoffels P, Heremans A. (Australas J Dermatol.;39(suppl):290, 1997)

Consultants in drug development

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