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Published Expertise
2014
  1. Kobalava Z, Villevalde S, Kotovskaya Y, Hinrichsen H, Petersen-Sylla M, Zaehringer A, Pang Y, Rajman I, Canadi J, Dahlke M, Lloyd P, Halabi A. Pharmacokinetics of serelaxin in patients with hepatic impairment: A single-dose, open-label, parallel-group study. Br J Clin Pharmacol. 2015 Jun;79(6):937-45.doi:10.1111/bcp 12572 2014 Dec 16. doi: 10.1111/bcp.12572. [Epub ahead of print]
  2. Weiss J, Baumann S, Theile D, Haefeli WE. Desmethyl bosentan displays a similar in vitro interaction profile as bosentan. Pulm Pharmacol Ther. 2014 Dec 19. pii: S1094-5539(14)00138-2. doi: 10.1016/j.pupt.2014.12.001. [Epub ahead of print]
  3. Joseph D, Rose P, Strelkowa N, Schultz A, Garcia J, Elgadi M, Huang F. Effect of faldaprevir on raltegravir pharmacokinetics in healthy volunteers. J Clin Pharmacol. 2014 Oct 28. doi: 10.1002/jcph.418. [Epub ahead of print]
  4. Huang F, Moschetti V, Lang B, Halabi A, Petersen-Sylla M, Yong CL, Elgadi M., Pharmacokinetics, safety, and tolerability of faldaprevir in patients with renal impairment. Antimicrob Agents Chemother. 2015 Jan;59(1):251-7. doi: 10.1128/AAC.03359-14 Epub  2014 Oct 27
  5. Gehin M, Sidharta PN, Gnerre C, Treiber A, Halabi A, Dingemanse J., Pharmacokinetic interactions between simvastatin and setipiprant, a CRTH2 antagonist. Eur J Clin Pharmacol. 2015 Jan;71(1):15-23. doi: 10.1007/s00228-014-1767-x. Epub 2014 Oct 18.
  6. Regina Freunscht, MSc, Norbert Clemens, MD, PhD, CPI The New European Clinical Trial Regulation : Administrative and Operational Changes, DOI 10.14524/CR-14-0030
  7. Hinrichs J, Schaumann F, Renne J, Schönfeld C, Faulenbach C, Winkler C, Gutberlet M, Krug N, Wacker F, Hohlfeld JM, Vogel-Claussen J. Phase-contrast MRI for detection of mild systemic hemodynamic response after segmental allergen challenge in asthmatic patients. Acad Radiol. 2014 Aug;21(8):994-1001. doi: 10.1016/j.acra.2014.03.003.
  8. Schaumann F, Frömke C, Dijkstra D, Alessandrini F, Windt H, Karg E, Müller M, Winkler C, Braun A, Koch A, Hohlfeld J, Behrendt H, Schmid O, Koch W, Schulz H, Krug N. Effects of ultrafine particles on the allergic inflammation in the lung of asthmatics: results of a double-blinded randomized cross-over clinical pilot study. Part Fibre Toxicol. 2014 Sep 10;11(1):39. doi: 10.1186/sl12989-014-0039-3.
  9. Spinelli T, Moresino C, Baumann S, Timmer W, Schultz A. Effects of combined netupitant and palonosetron (NEPA), a cancer supportive care antiemetic, on the ECG of healthy subjects: an ICH E14 thorough QT trial. Springerplus. 2014 Jul 29;3:389. doi: 10.1186/2193-1801-3-389. eCollection 2014.
  10. Schnell D, Buschke S, Fuchs H, Gansser D, Goeldner RG, Uttenreuther-Fischer M, Stopfer P, Wind S, Petersen-Sylla M, Halabi A, Koenen R. . Pharmacokinetics of afatinib in subjects with mild or moderate hepatic impairment. Cancer Chemother Pharmacol. 2014 Aug;74(2):267-75. doi: 10.1007/s00280-014-2484-y. Epub 2014 Jun 7.
  11. N Clemens  Investigator Training and Eduction  for Clinical Trials: Current Developments within the European Union. Clinical Researcher June 2014
  12. De Kam PJ, van Kuijk J, Lillin O, Post T, Thomsen T. The Effect of Therapeutic and Supratherapeutic Oral Doses of Nomegestrol Acetate (NOMAC)/17?-Estradiol (E2) on QTcF Intervals in Healthy Women: Results from a Randomized, Double-Blind, Placebo- and Positive-Controlled Trial. Clin Drug Investig. 2014 Jun;34(6):413-20 doi:10.1007/s40261-014-0190-5.
  13. Winkler C, Witte L, Moraw N, Faulenbach C, Müller M, Holz O, Schaumann F, Hohlfeld JM. Impact of endobronchial allergen provocation on macrophage phenotype in asthmatics. BMC Immunol. 2014 Mar 10;15:12. doi: 10.1186/1471-2172-15-12
  14. Halabi A, Maatouk H, Siegler KE, Faisst N, Hinrichsen H. Pharmacokinetics and safety of teneligliptin in subjects with hepatic impairment. Clin Pharmacol Drug Dev. 2014 Jul;3(4):290-6. doi: 10.1002/cpdd.89. Epub 2014 Feb 17.
  15. Vogel-Claussen J, Renne J, Hinrichs J, Schönfeld C, Gutberlet M, Schaumann F, Winkler C, Faulenbach C, Krug N, Wacker FK, Hohlfeld JM. Quantification of pulmonary inflammation after segmental allergen challenge using turbo-inversion recovery-magnitude magnetic resonance imaging. Am J Respir Crit Care Med. 2014 Mar 15;189(6):650-7. doi: 10.1164/rccm.201310-1825OCT
2013
  1. Cawello W, Fuhr U, Hering U, Maatouk H, Halabi A. Impact of impaired renal function on the pharmacokinetics of the antiepileptic drug lacosamide. Clin Pharmacokinet. 2013 Oct;52(10):897-906. doi: 10.1007/s40262-013-0080-7.
  2. Oscar M Camacho, Christopher J Shepperd, Alison Eldridge, Ingo Meyer, Christopher J Proctor. Reference change values to assess changes in concentrations of biomarkers of exposure in individuals participating in a cigarette-switching study. Clinical Chemistry and Laboratory Medicine 10/2013.
  3. Silva H, Stonier P, Buhler F, Deslypere JP, Criscuolo D, Nell G, Massud J, Geary S, Schenk J, Kerpel-Fronius S, Koski G, Clemens N, Klingmann I, Kesselring G, van Olden R, Dubois D. Core competencies for pharmaceutical physicians and drug development scientists. Front Pharmacol. 2013 Aug 26;4:105.
  4. Stoll F, Burhenne J, Lausecker B, Weiss J, Thomsen T, Haefeli WE, Mikus G.
    Reduced exposure variability of the CYP3A substrate simvastatin by dose
    individualization to CYP3A activity. J Clin Pharmacol. 2013 Nov;53-(11):1199-204.  doi:
    10.1002/jcph.161. Epub 2013 Aug 31
  5. Honorio S, Stonier P, Buhler F, Deslypere JP, Criscuolo D, Nell G, Massud J, Geary S, Schenk J, Kerpel-Fronius S, Koski G, Clemens N, Klingmann I, Kesselring G, van Olden R, Dubois D. Core Competences for Pharmaceutical Physician and Drug Development Scientists. Front. Pharmacol.4:105.doi:10.3389/fphar.2013.00105 Aug 2013
  6. Greulich T, Hattesohl A, Grabisch A, Koepke J, Schmid S, Noeske S, Nell C, Wencker M, Jörres RA, Vogelmeier CF, Köhler U, Koczulla AR. Detection of obstructive sleep apnoea by an electronic nose. Eur Respir J. 2013 Jul;42(1):145-55.
    doi: 10.1183/09031936.00091712. Epub 2012 Oct 25
  7. Christopher J Shepperd, Nik Newland, Alison Eldridge, Don Graff, Ingo Meyer. A single-blinded, single-centre, controlled study in healthy adult smokers to identify the effects of a reduced toxicant prototype cigarette on biomarkers of exposure and of biological effect versus commercial cigarettes.  BMC Public Health 07/2013; 13(1):690.
  8. Cawello W, Fuhr U, Hering U, Maatouk H, Halabi A. Impact of Impaired Renal Function on the Pharmacokinetics of the Antiepileptic Drug Lacosamide. Clin Pharmacokinet. 2013 Jun 5. 52:897-906 DOI 10.1007
  9. Schwab D, Portron A, Backholer Z, Lausecker B, Kawashima K. A Novel Double-Tracer Technique to Characterize Absorption, Distribution, Metabolism and Excretion (ADME) of [(14)C]Tofogliflozin After Oral Administration and Concomitant Intravenous Microdose Administration of [ (13)C]Tofogliflozin in Humans. Clin Pharmacokinet. 2013 Jun;52(6):463-73. doi: 10.1007/s40262-013-0051-z.
  10. Stass H, Nagelschmitz J, Willmann S, Delesen H, Gupta A, Baumann S. Inhalation of a dry powder ciprofloxacin formulation in healthy subjects: a phase I study. Clin Drug Investig. 2013 Jun;33(6):419-27. doi: 10.1007/s40261-013-0082-0
  11. DEPBrossard P, Derendorf H, Xu J, Maatouk H, Halabi A, Dingemanse J. Pharmacokinetics and pharmacodynamics of ponesimod, a selective S1P1 receptor modulator, in the first-in-human study. Br J Clin Pharmacol. 2013 Dec;76(6):888-96. doi: 10.1111/bcp.12129
  12. Nave R, Halabi A, Herzog R, Schaffer P, Diefenbach J, Krause S, Berghöfer P, Lahu G, Hartmann M.  Pharmacokinetics of teduglutide in subjects with renal impairment. Eur J Clin Pharmacol. 2013 May;69(5):1149-55. Doi 10.1007/s00227-012-1455-7
  13. Halabi A, Maatouk H, Siegler KE, Faisst N, Lufft V, Klause N. Pharmacokinetics of Teneligliptin in Subjects With Renal Impairment. Clinical Pharmacology in Drug Dev. 2013 Jul;2(3):246-54. Doi 10.1002/cpdd.29, Epub  14 May 2013.
  14. Kjetil Berge, Fabiana Piscitelli, Nils Hoem, Cristoforo Silvestri, Ingo Meyer, Sebastiano Banni, Vincenzo Di Marzo. Chronic treatment with krill powder reduces plasma triglyceride and anandamide levels in mildly obese men.  Lipids in Health and Disease 05/2013; 12(1):78
  15. Spinelli T, Moresino C, Baumann S, Timmer W. A randomized, controlled, thorough ECG trial to investigate the effects of netupitant and palonosetron (NEPA) combinations on ECG of healthy volunteers. MASCC poster 2013
  16. Spinelli T, Moresino C, Baumann S, Timmer W.  Effects of NEPA (novel combination of netupitant and palonosetron) on ECG of healthy volunteers: a randomized, controlled, thorough ECG trial. ASCO poster 2013
  17. Plock N, Facius A, Hartmann L, Baumann S, Nave R. An innovative Phase I population pharmacokinetic approach to investigate the pharmacokinetics of an intranasal fentanyl spray in healthy subjects. Int J Clin Pharmacol Ther. 2013 Jun;51(6):495-508. doi:10.5414/CP201867.
  18. Stass H, Nagelschmitz J, Willmann S, Delesen H, Gupta A, Baumann S. Inhalation of a dry powder ciprofloxacin formulation in healthy subjects: a phase I study. Clin Drug Investig. 2013 Jun;33(6):419-27. doi: 10.1007/s40261-013-0082-0.
  19. Calcagnile S, Lanzarotti C, Rossi G, Henriksson A, Kammerer KP, Timmer W. Effect of netupitant, a highly selective NK(1) receptor antagonist, on the pharmacokinetics of palonosetron and impact of the fixed dose combination of netupitant and palonosetron when coadministered with ketoconazole, rifampicin, and oral contraceptives. Support Care Cancer. 2013 Jun 11.
  20. Härtter S, Sennewald R, Schepers C, Baumann S, Fritsch H, Friedman J. Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers. Eur J Clin Pharmacol. 2013 Mar;69(3):327-39. Doi 10.1007/s00228-012-1304-8.Epub 2012
  21. Christopher J Shepperd, Alison Eldridge, Oscar M Camacho, Kevin McAdam, Christopher J Proctor, Ingo Meyer. Changes in levels of biomarkers of exposure observed in a controlled study of smokers switched from conventional to reduced toxicant prototype cigarettes.  Regulatory Toxicology and Pharmacology 03/2013.
  22. Janssen O, Schaumann F, Holz O, Lavae-Mokhtari B, Welker L, Winkler C, Biller H, Krug N, Hohlfeld JM. Low-dose endotoxin inhalation in healthy volunteers--a challenge model for early clinical drug development BMC Pulm Med. 2013 Mar 28 
  23. Kubitza D, Roth A, Becka M, Alatrach A, Halabi A, Hinrichsen H, Mueck W. Effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of a single dose of rivaroxaban – an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol. 2013 Jan 8.
  24. Christopher J. Shepperd, Alison Eldridge, Oscar M. Camacho, Kevin McAdam, Christopher J. Proctor, Ingo Meyer. Corrigendum to “Changes in levels of biomarkers of exposure observed in a controlled study of smokers switched from conventional to reduced toxicant prototype cigarettes”.  Regulatory Toxicology and Pharmacology 01/2013; 67(3):536
2012
  1. Lillin-de Vries O, De Kam P-J, Van Kuijk J, Post T, Thomsen T, Beligotti F. A population pharmacokinetic-pharmacodynamic analysis of Nomegestrol Acetate, Estradiol and Estrone and their relationship on QTcF intervals in healthy women receiving multiple oral doses of the combined Oral Contraceptive NOMAC/E2. Poster Figo 2012
  2. De Kam P-J, Van Kuijk J, Lillin-de Vries O, Post T, Thomsen T, Beligotti F. A randomised, double-blind, placebo- and positive-controlled parallel-group trial to investigate the effect of multiple oral doses of NOMAC/E2 on QTcF iIntervals in healthy women. Poster Figo 2012
  3. Nave R, Halabi A, Herzog R, Schaffer P, Diefenbach J, Krause S, Berghöfer P, Lahu G, Hartmann M. Pharmacokinetics of teduglutide in subjects with renal impairment. Eur J Clin Pharmacol. 2012 Nov 28. [Epub ahead of print]
  4. Cawello W, Bökens H, Nickel B, Andreas JO, Halabi A . Tolerability, pharmacokinetics, and bioequivalence of the tablet and syrup formulations of lacosamide in plasma, saliva, and urine: Saliva as a surrogate of pharmacokinetics in the central compartment. Epilepsia. 2012 Nov 13. doi: 10.1111/j.1528-1167.2012.03725.x. [Epub ahead of print]
  5. Schmid ST, Koepke J, Dresel M, Hattesohl A, Frenzel E, Perez J, Lomas DA, Miranda E, Greulich T, Noeske S, Wencker M, Teschler H, Vogelmeier C, Janciauskiene S, Koczulla AR The effects of weekly augmentation therapy in patients with PiZZ ?1-antitrypsin deficiency. Int J Chron Obstruct Pulmon Dis. 2012;7:687-96. doi: 10.2147/COPD.S34560. Epub 2012 Sep 28.
  6. Härtter S, Sennewald R, Schepers C, Baumann S, Fritsch H, Friedman J, Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers. Eur J Clin Pharmacol. 2012 Jul 11.
    [Epub ahead of print]
  7. A H Schmitt-Hoffmann, B Roos, A Schoetzau, P T Leese, I Meyer, J van de Wetering, P Kovacs. Oral alitretinoin: a review of the clinical pharmacokinetics and pharmacodynamics.  Expert Review of Clinical Pharmacology 07/2012; 5(4):373-88.
  8. Hartmann M, Timmer W, Schultz A, Nave R, Luehmann R, Krause S, Lahu G, Scholpp J (2012) A thorough QT study of teduglutide in healthy subjects. Clinical Pharmacology in Drug Development 1(2):57-66.
  9. Lindskov Krog P, Østerberg O, Gundorf Drewes P, Rembratt A, Schultz A, Timmer W, (2012) Pharmacokinetic and tolerability profile of pridopidine in healthy-volunteer poor and extensive CYP2D6 metabolizers, following single and multiple dosing. Eur J Drug Metab Pharmacokinet 2012, Sept 5 (Epub ahead of print)
  10. Härtter S, Koenen-Bergmann M, Sharma A, Nehmiz G, Lemke U, Timmer W, Reilly PA.  Decrease in the oral bioavailability of dabigatran etexilate after co-medication with rifampicin. Br J Clin Pharmacol. 2012 Sept; 74(3):490-500
  11. Badorrek P, Dick M, Emmert L, Schaumann F, Koch W, Hecker H, Murdoch R, Hohlfeld JM, Krug N. Pollen starch granules in bronchial inflammation Ann Allergy Asthma Immunol. 2012 Sep; Epub 2012 Jul 18.
  12. de Kam PJ, van Kuijk J, Smeets J, Thomsen T, Peeters P. Sugammadex is not associated with QT/QTc prolongation: methodology aspects of an intravenous moxifloxacin-controlled thorough QT study. Int J Clin Pharmacol Ther. 2012 Aug; 50 (8):595-604 Epub 2012 Jun 26
  13. Vogel-Claussen O, Schaumann F, Renne, J, Hinrichs J, Schoenfeld C, Gutberlet M, Hüper K, Winkler C, Faulenbach C, Krug N, Wacker F,Hohlfeld JM Semi-Quantitative Assessment Of Localized Pulmonary Inflammation By Magnetic Resonance Imaging In Patients With Mild Allergic Asthma Following Segmental Allergen Challenge Am J Respir Crit Care Med Volume 185, Meeting Abstracts; May 1, 2012
  14. Vogel-Claussen O, Renne J, Hinrichs J , Schoenfeld C, Gutberlet M, Schaumann F, Winkler C, Faulenbach C, Krug N, Wacker F, Hohlfeld JM Quantification Of Pulmonary Inflammation After Endobronchial Allergen Challenge Using Turbo Inversion Recovery Magnitude (TIRM) MRI Am J Respir Crit Care Med Volume 185, Meeting Abstracts; May 1, 2012
  15. F. Schaumann, O. Holz, O. Janssen, B. Lavae-Mokhtari, L. Witte, H. Biller, N. Krug, J. M. Hohlfeld, Low-Dose Endotoxin Inhalation in Healthy Volunteers: a Challenge Model for Early Clinical Drug Development of Novel Anti-Inflammatory Compounds Am J Respir Crit Care Med Volume 85, Meeting Abstracts; May 1, 2012
  16. C. Winkler, H. Carstens,N. Moraw, M. Mueller, F. Schaumann, C. Faulenbach, J. M. Hohlfeld, Alternative Activation of Macrophages During the Allergic Airway Inflammation Alters Antigen Presenting Capacities Am J Respir Crit Care Med Volume 185, Meeting Abstracts; May 1, 2012
  17. Olaf Holz, Frank Schaumann, Ole Janben, Bianca Lavae-Mokhtari, Lena Witte, Norbert Krug, J M. Heinrich, Jens M. Hohlfeld Conference Paper: Depletion Of Neutrophils From Induced Sputum Using A Novel Bead And Sieve-Separation System  American Thoracic Society 2012 International Conference, May 18-23, 2012
  18. Timmerman P, Lausecker B, Barosso B, van Amsterdam P, Luedtke S, Dijksman J. 'Large Meets Small': connecting the bioanalytical community around peptide and protein bioanalysis with LC-MS(/MS). Bioanalysis. 2012 Mar;4(6):627-31.doi: 10.4155/bio.12.37.
  19. Halperin SA, Wardb B, Cooper C, Predy G, Diaz-Mitoma F, Dionne M, Embree J, McGeer A,  Zickler P , Moltz KH, Martz R, Meyer I, McNeil S, Langley JM, Martins E, William L. Heyward,J. Tyler Martin. Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate ligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18–55 years of age.Vaccine, Volume 30 (2012) Pages 2556–2563
  20. Scott A Halperin, Brian Ward, Curtis Cooper, Gerald Predy, Francisco Diaz-Mitoma, Marc Dionne, Joanne Embree, Allison McGeer, Paul Zickler, Karl-Heinz Moltz, René Martz, Ingo Meyer, Shelly McNeil, Joanne M Langley, Eduardo Martins, William L Heyward, J Tyler Martin . Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18-55 years of age.  Vaccine 02/2012; 30(15):2556-63
2011
  1. Feuring M, Wehling M, Schultz A. Dalteparin dose-dependently increases ROTEM(®) thrombelastography parameters only at supratherapeutic anti-factor Xa levels: an in vitro study. Clin Exp Pharmacol Physiol. 2011 Nov;38(11):783-6.
  2. Feuring M, Wehling M, Schultz A. Lepirudin dose-dependently increases thrombelastography parameters at therapeutic plasma concentrations as measured with ROTEM® - a pilot study. Int J Clin Pharmacol Ther. 2011 Oct;49(10):626-8.
  3. Ostenfeld T, Price J, Albanese M, Bullman J, Guillard F, Meyer I, Leeson R, Costantin C, Ziviani L, Nocini PF, Milleri S. A randomized, controlled study to investigate the analgesic efficacy of single doses of the cannabinoid receptor-2 agonist GW842166, ibuprofen or placebo in patients with acute pain following third molar tooth extraction. Clinical  Journal of Pain. 2011 Oct; 27, Pages 668-76.
  4. Zoerner AA, Stichtenoth DO, Engeli S, Batkai S, Winkler C, Schaumann F, Janke J, Holz O, Krug N, Tsikas D, Jordan J, Hohlfeld JM. Allergen challenge increases anandamide in bronchoalveolar fluid of with allergic asthma. Clin Pharmacol Ther. 2011 Epub 2011 Jun 29.
  5. Sidharta PN, van Giersbergen PL, Halabi A, Dingemanse J. Macitentan: entry-into-humans study with a new endothelin receptor antagonist. Eur J Clin Pharmacol. 2011 Oct;67(10):977-84. Epub 2011 May 4.
  6. Obreja O, Kluschina O, Mayer A, Hirth M, Schley M, Schmelz M, Rukwied R. NGF enhances electrically induced pain, but not axon reflex sweating. Pain. 2011 Aug;152(8):1856-63. Epub 2011 May 4.
  7. A H Schmitt-Hoffmann, B Roos, J Sauer, T Brown, E Weidekamm, I Meyer, M Schleimer, J Maares. Low levels of alitretinoin in seminal fluids after repeated oral doses in healthy men. Clinical and Experimental Dermatology 04/2011; 36 Suppl 2:12-7
  8. A H Schmitt-Hoffmann, B Roos, J Sauer, J Spickermann, J Maares, A Schoetzau, I Meyer. Pharmacokinetic interactions between alitretinoin and ketoconazole or simvastatin or ciclosporin A. Clinical and Experimental Dermatology 04/2011; 36 Suppl 2:24-8.
  9. Abbott RW, Gordon B, van Amsterdam P, Lausecker B, Brudny-Kloeppel M, Smeraglia J, Romero F, Globig S, Golob M, Knutsson M, Herling C, Vieser E, Timmerman P. From challenges to solutions. European Bioanalysis Forum 3rd Annual Open Symposium, Hesperia Towers, Barcelona, Spain, 1-3 December 2010. Bioanalysis. 2011 Apr;3(8):833-8. doi: 10.4155/bio.11.52.
  10. Badorrek P, Dick M, Hecker H, Schaumann F, Sousa AR, Murdoch R, Hohlfeld JM, Krug N.  Anti-allergic drug testing in an environmental challenge chamber is suitable both in and out of the relevant pollen season Ann Allergy Asthma Immunol. 2011 Epub 2011 Feb 5.
  11. Clemens N. Clinical Investigator and Site Staff Training Requirements on al Global Scale, Monitor, February 2011
  12. Serra DB, Sun H, Karwowska S, Praestgaard J, Halabi A, Stein DS. Single-dose pharmacokinetics, safety, and tolerability of albinterferon alfa-2b in subjects with end-stage renal disease on hemodialysis compared to those in matched healthy volunteers. Antimicrob Agents Chemother. 2011 Feb; 55(2):473-7. Epub 2010 Nov 22.
  13. Schmitt-Hoffmann A, Roos B, Maares J, Sauer J, Spickermann J, Meyer I, Kaufhold A.
    A2-572 Pharmacokinetics and Safety of the Novel Sulfactam Antibiotic BAL30072 after Single Ascending Dose Infusions in Healthy Volunteers - Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago, USAChemotherapy (ICAAC) in Chicago, USA 2011
  14. Atochina-Vasserman EN, Winkler C, Abramova H, Schaumann F, Krug N, Gow AJ, Beers MF, Hohlfeld JM. Segmental allergen challenge alters multimeric structure and function of surfactant protein D in humans Am J Respir Crit Care Med. 2011 Epub 2010 Dec 3.
2010
  1. Rukwied R, Mayer A, Kluschina O, Obreja O, Schley M, Schmelz M. NGF induces non-inflammatory localized and lasting mechanical and thermal hypersensitivity in human skin. Pain 2010 Mar;148(3):407-13. Epub 2009 Dec 22.
  2. Clemens N. Outsourcing in Drug Development. Drug Development, 2010;5: 48-9
  3. Timmer W, Massan E, Jiménez E, Seoane B, de Miquel G, Ruiz S. Single doses of LAS100977, a long-acting beta2-agonist, show high activity and long duration in healthy subjects. Poster presented at the American Thoracic Society International Conference, New Orleans, Louisiana, May 14-19, 2010.
  4. de Kam PJ, van Kuijk J, Prohn M, Thomsen T, Peeters P. Effects of sugammadex doses up to 32 mg/kg alone or in combination with rocuronium or vecuronium on QTc prolongation: a thorough QTc study. Clin Drug Investig. 2010;30(9):599-611.
  5. Feuring M, Wehling M, Burkhardt H, Schultz A. Coagulation status in coronary artery disease patients with type II diabetes mellitus compared with non-diabetic coronary artery disease patients using the PFA-100® and ROTEM®. Platelets. 2010;21(8):616-22. Epub 2010 Sep 1.
  6. Katherina Sewald, Simone Switalla, Saskia Knothe, Frauke Prenzler, Christine Förster, Olaf Pfennig, Christian Martin, Thomas Ebensen, Carlos Guzmán, Frank Schaumann, Norbert Krug, Armin Braun Conference Paper: The New Adjuvant BPPcysMPEG Activates Innate Immune Responses In Human Precision-cut Lung Slices (PCLS) American Thoracic Society 2010 International Conference, May 14-19, 2010
  7. Carla Winkler, Heike Biller, Sabine Rochlitzer, Saskia Knothe, Meike Mueller, Frank Schaumann, Norbert Krug, Jens M. Hohlfeld Conference Paper: Differential Effect Of Surfactant Protein-D On T-lymphocyte Proliferation Is Dependent On The Phenotype Of Dendritic Cells American Thoracic Society 2010 International Conference, May 14-19, 2010
  8. Frank Schaumann, Edith Berger-Preiss, Wolfgang Koch, Dorothea Dijkstra, Meike Müller, Armin Braun, Jens Hohlfeld, Norbert Krug Conference Paper: Influence Of Diesel Exhaust Particles (DEP) With And Without Organic Compounds On The Allergic Inflammation In Asthmatic Subjects American Thoracic Society 2010 International Conference, May 14-19, 2010
  9. Switalla S, Lauenstein L, Prenzler F, Knothe S, Förster C, Fieguth HG, Pfennig O, Schaumann F, Martin C, Guzman CA, Ebensen T, Müller M, Hohlfeld JM, Krug N, Braun A, Sewald K. Natural innate cytokine response to immunomodulators and adjuvants in human precision-cut lung slices Toxicol Appl Pharmacol. 2010 Apr 29. [Epub ahead of print]
  10. Feuring M, Ruf A, Schultz A, Wehling M.The PFA-100R cannot detect blood group-dependent inhibition of platelet function by eptifibatide or abciximab at therapeutic plasma concentrations. Platelets. 2010;21(3):176-82.
  11. Becker S, Allen C, Schenk J, Clemens N and the IFAPP Executive Committee. Shaping IFAPP’s future, a process to help the International Federation of Associations of Pharmaceutical Physicians evolve. Pharm Med 2010; 24 (1): 7-10
  12. Norbert Clemens. Pharmaceutical Medicine in Germany. Pharm Med 2010;24(1): 11 13
  13. Rukwied R, Mayer A, Kluschina O, Obreja O, Schley M, Schmelz M. NGF induces non-inflammatory localized and lasting mechanical and thermal hypersensitivity in human skin. Pain. 2010 Mar;148(3):407-13. Epub 2009 Dec 22.
  14. K. Sewald, S. Seehase, S. Switalla, H. D. Lauenstein, C. Foerster, C. Schlumbohm, E. Fuchs, F. J. Kaup, N. Krug, F. Schaumann, A. Braun Article: Ex vivo lung culture models to study respiratory inflammation and their relevance for in vivo: An interspecies comparison Toxicology Letters - TOXICOL LETT. 01/2010; 196.

2015–2017

  1. Funan Huang, Antoinette Ajavon-Hartmann, Erya Huang, John Lettieri, Rong Liu, Carol Pena, Matthias Berse. No Effect of Levothyroxine and Levothyroxine-induced Subclinical Thyrotoxicosis on the Pharmacokinetics of Sorafenib in Healthy Male Subjects Thyroid. July 2017, ahead of print.
  2. Kropeit D, Scheuenpflug J, Erb-Zohar K, Halabi A, Stobernack HP, Hulskotte EGJ, van Schanke A, Zimmermann H, Rübsamen-Schaeff H.  Pharmacokinetics and safety of letermovir, a novel anti-human cytomegalovirus drug, in patients with renal impairment. Br J Clin Pharmacol. 2017 Mar 26. doi: 10.1111/bcp.13292. [Epub ahead of print]
  3. Liu Y, Boettcher MF, Schmidt A, Unger S, Halabi A, Brendel E, Blode H. Pharmacokinetics and safety of nifedipine GITS/candesartan fixed-dose combination in subjects with hepatic impairmen. Int J Clin Pharmacol Ther. 2016 Dec 27. doi: 10.5414/CP202700. [Epub ahead of print]
  4. Pimenta E, Jensen M, Jung D, Schaumann F, Boxnick S, Truebel H. Effect of Diet on Serum Creatinine in Healthy Subjects During a Phase I Study. J Clin Med Res. 2016 Nov;8(11):836-839.
  5. Heinig R, Kimmeskamp-Kirschbaum N, Halabi A, Lentini S. Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Finerenone (BAY 94-8862) in Individuals With Renal Impairment. Clin Pharmacol Drug Dev. 2016 Mar 31. doi: 10.1002/cpdd.263. [Epub ahead of print]
  6. Wiebe S, Schnell D, Külzer R, Gansser D, Weber A, Wallenstein G, Halabi A, Conrad A, Wind S. Influence of Renal Impairment on the Pharmacokinetics of Afatinib: An Open-Label, Single-Dose Study. Eur J Drug Metab Pharmacokinet. 2016 Jul 19. [Epub ahead of print]
  7. Kaufmann P, Cruz HG, Krause A, Ul? I, Halabi A, Dingemanse J. Pharmacokinetics of the novel oral prostacyclin receptor agonist selexipag in subjects with hepatic or renal impairment. Br J Clin Pharmacol. 2016 Apr 7. doi: 10.1111/bcp.12963. [Epub ahead of print]
  8. Kunz C, Luedtke D, Unseld A, Hamilton A, Halabi A, Wein M, Formella S. Pharmacokinetics and safety of olodaterol administered with the Respimat Soft Mist inhaler in subjects with impaired hepatic or renal function. Int J Chron Obstruct Pulmon Dis. 2016 Mar 18;11:585-95. doi: 10.2147/COPD.S94234. eCollection 2016.
  9. O. Holz,  L. Tan, F. Schaumann, M. Müller, D. Scholl, R. Hidi, A. McLeod, N. Krug, J.M. Hohlfeld, Inter- and intrasubject variability of the inflammatory response to segmental endotoxin challenge in healthy volunteers, Pulmonary Pharmacology & Therapeutics 35 (2015) 50- 59
  10. Rabinovich-Guilatt L, Siegler KE, Schultz A, Halabi A, Rembratt A, Spiegelstein O. The effect of mild and moderate renal impairment on the pharmacokinetics of pridopidine, a new drug for Huntington's Disease. Br J Clin Pharmacol. 2015 Sep 25. doi: 10.1111/bcp.12792. [Epub]
  11. Calcagnile S, Lanzarotti C, Gutacker M, Jakob-Rodamer V, Peter Kammerer K, Timmer W. Evaluation of the effect of food and age on the pharmacokinetics of oral netupitant and palonosetron in healthy subjects: A randomized, open-label, crossover phase 1 study. Clin Pharmacol Drug Dev. 2015 Sep;4(5):377-86. doi: 10.1002/cpdd.192. Epub 2015 May 29
  12. Homburg U, Renz H, Timmer W, Hohlfeld JM, Seitz F, Lüer K, Mayer A, Wacker A, Schmidt O, Kuhlmann J, Turowska A, Roller J, Kutz K, Schlüter G, Krug N, Garn H. Safety and tolerability of a novel inhaled GATA3 mRNA targeting DNAzyme in patients with TH2-driven asthma. J Allergy Clin Immunol. 2015 Sep;136(3):797-800. doi: 10.1016/j.jaci.2015.02.018. Epub 2015 Apr 2. No abstract available.
  13. Krug N, Hohlfeld JM, Kirsten AM, Kornmann O, Beeh KM, Kappeler D, Korn S, Ignatenko S, Timmer W, Rogon C, Zeitvogel J, Zhang N, Bille J, Homburg U, Turowska A, Bachert C, Werfel T, Buhl R, Renz J, Garn H, Renz H. Allergen-induced asthmatic responses modified by a GATA3-specific DNAzyme. N Engl J Med. 2015 May 21;372(21):1987-95. doi: 10.1056/NEJMoa1411776. Epub 2015 May 17.
  14. Faißt N, Clemens N. Erfahrungen im speziellen Umfeld von 'Early Phase Studies'. Pharmazeutische Medizin (2015): 17 (3). 144-7
  15. Dahlke M, Halabi A, Canadi J, Tsubouchi C, Machineni S, Pang Y. Pharmacokinetics of serelaxin in patients with severe renal impairment or end-stage renal disease requiring hemodialysis: A single-dose, open-label, parallel-group study. J Clin Pharmacol. 2015 Aug 4. doi: 10.1002/jcph.607. [Epub ahead of print]
  16. de Kam PJ, van Kuijk JH, Zandvliet A, Thomsen T. Single therapeutic and supratherapeutic doses of corifollitropin alfa, a sustained follicle stimulant, do not prolong the QTcF-interval in healthy postmenopausal volunteers. Int J Clin Pharmacol Ther. 2015 Jul 31. [Epub ahead of print]
  17. N Clemens. In Search of Risk Management / Mitigation and Optimal Performance for Clinical Trials. Clinical Researcher June 2015  doi: 10.14524/CR-15-4070
  18. Shepperd CJ, Newland N, Eldridge A, Haswell L, Lowe F, Papadopoulou E, Camacho O, Proctor CJ, Graff D, Meyer I. Changes in levels of biomarkers of exposure and  biological effect in a controlled study of smokers switched from conventional cigarettes to reduced-toxicant-prototype cigarettes. Regul Toxicol Pharmacol. 2015 Jul;72(2):273-91.doi 10.1016/j.yrtph.2015.04.016  Epub 2015 May 10
  19. Ouwerkerk-Mahadevan S, Halabi A, Cieslarová B, Aerts I, Witek J, Van Solingen-Ristea R, Luo D. Pharmacokinetics of bound and unbound telaprevir in cirrhotic patients with moderate and severe hepatic impairment. J Clin Pharmacol. 2015 Oct;55(10):1147-56. doi: 10.1002/jcph.545. Epub 2015 Jul 7
  20. Kaufmann P, Niglis S, Bruderer S, Segrestaa J, Äänismaa P, Halabi A, Dingemanse J. Effect of lopinavir/ritonavir on the pharmacokinetics of selexipag an oral prostacyclin receptor agonist and its active metabolite in healthy subjects. Br J Clin Pharmacol. 2015 Apr 7. doi: 10.1111/bcp.12650. Epub 2015 Jun 12
  21. Renne J, Hinrichs J, Schönfeld C, Gutberlet M, Winkler C, Faulenbach C, Jakob P, Schaumann  F, Krug N, Wacker F, Hohlfeld JM, Vogel-Claussen J. Noninvasive Quantification of Airway Inflammation Following Segmental Allergen Challenge with Functional MR Imaging: A Proof of Concept Study. Radiology. 2015 Jan;274(1):267-75. doi: 10.1148/radiol.14132607. Epub 2014 Sep 8.
  22. Kobalava Z, Villevalde S, Kotovskaya Y, Hinrichsen H, Petersen-Sylla M, Zaehringer A, Pang Y, Rajman I, Canadi J, Dahlke M, Lloyd P, Halabi A. Pharmacokinetics of serelaxin in patients with hepatic impairment: A single-dose, open-label, parallel-group study. Br J Clin Pharmacol. 2015 Jun;79(6):937-45.doi:10.1111/bcp 12572 2014 Dec 16. doi: 10.1111/bcp.12572. [Epub ahead of print]
  23. Weiss J, Baumann S, Theile D, Haefeli WE. Desmethyl bosentan displays a similar in vitro interaction profile as bosentan. Pulm Pharmacol Ther. 2014 Dec 19. pii: S1094-5539(14)00138-2. doi: 10.1016/j.pupt.2014.12.001. [Epub ahead of print]
  24. Joseph D, Rose P, Strelkowa N, Schultz A, Garcia J, Elgadi M, Huang F. Effect of faldaprevir on raltegravir pharmacokinetics in healthy volunteers. J Clin Pharmacol. 2014 Oct 28. doi: 10.1002/jcph.418. [Epub ahead of print]
  25. Huang F, Moschetti V, Lang B, Halabi A, Petersen-Sylla M, Yong CL, Elgadi M., Pharmacokinetics, safety, and tolerability of faldaprevir in patients with renal impairment. Antimicrob Agents Chemother. 2015 Jan;59(1):251-7. doi: 10.1128/AAC.03359-14 Epub  2014 Oct 27
  26. Gehin M, Sidharta PN, Gnerre C, Treiber A, Halabi A, Dingemanse J., Pharmacokinetic interactions between simvastatin and setipiprant, a CRTH2 antagonist. Eur J Clin Pharmacol. 2015 Jan;71(1):15-23. doi: 10.1007/s00228-014-1767-x. Epub 2014 Oct 18.
  27. Regina Freunscht, MSc, Norbert Clemens, MD, PhD, CPI The New European Clinical Trial Regulation : Administrative and Operational Changes, DOI 10.14524/CR-14-0030
  28. Hinrichs J, Schaumann F, Renne J, Schönfeld C, Faulenbach C, Winkler C, Gutberlet M, Krug N, Wacker F, Hohlfeld JM, Vogel-Claussen J. Phase-contrast MRI for detection of mild systemic hemodynamic response after segmental allergen challenge in asthmatic patients. Acad Radiol. 2014 Aug;21(8):994-1001. doi: 10.1016/j.acra.2014.03.003.
  29. Schaumann F, Frömke C, Dijkstra D, Alessandrini F, Windt H, Karg E, Müller M, Winkler C, Braun A, Koch A, Hohlfeld J, Behrendt H, Schmid O, Koch W, Schulz H, Krug N. Effects of ultrafine particles on the allergic inflammation in the lung of asthmatics: results of a double-blinded randomized cross-over clinical pilot study. Part Fibre Toxicol. 2014 Sep 10;11(1):39. doi: 10.1186/sl12989-014-0039-3.
  30. Spinelli T, Moresino C, Baumann S, Timmer W, Schultz A. Effects of combined netupitant and palonosetron (NEPA), a cancer supportive care antiemetic, on the ECG of healthy subjects: an ICH E14 thorough QT trial. Springerplus. 2014 Jul 29;3:389. doi: 10.1186/2193-1801-3-389. eCollection 2014.
  31. Schnell D, Buschke S, Fuchs H, Gansser D, Goeldner RG, Uttenreuther-Fischer M, Stopfer P, Wind S, Petersen-Sylla M, Halabi A, Koenen R. . Pharmacokinetics of afatinib in subjects with mild or moderate hepatic impairment. Cancer Chemother Pharmacol. 2014 Aug;74(2):267-75. doi: 10.1007/s00280-014-2484-y. Epub 2014 Jun 7.
  32. N Clemens  Investigator Training and Eduction  for Clinical Trials: Current Developments within the European Union. Clinical Researcher June 2014
  33. De Kam PJ, van Kuijk J, Lillin O, Post T, Thomsen T. The Effect of Therapeutic and Supratherapeutic Oral Doses of Nomegestrol Acetate (NOMAC)/17?-Estradiol (E2) on QTcF Intervals in Healthy Women: Results from a Randomized, Double-Blind, Placebo- and Positive-Controlled Trial. Clin Drug Investig. 2014 Jun;34(6):413-20 doi:10.1007/s40261-014-0190-5.
  34. Winkler C, Witte L, Moraw N, Faulenbach C, Müller M, Holz O, Schaumann F, Hohlfeld JM. Impact of endobronchial allergen provocation on macrophage phenotype in asthmatics. BMC Immunol. 2014 Mar 10;15:12. doi: 10.1186/1471-2172-15-12
  35. Halabi A, Maatouk H, Siegler KE, Faisst N, Hinrichsen H. Pharmacokinetics and safety of teneligliptin in subjects with hepatic impairment. Clin Pharmacol Drug Dev. 2014 Jul;3(4):290-6. doi: 10.1002/cpdd.89. Epub 2014 Feb 17.
  36. Vogel-Claussen J, Renne J, Hinrichs J, Schönfeld C, Gutberlet M, Schaumann F, Winkler C, Faulenbach C, Krug N, Wacker FK, Hohlfeld JM. Quantification of pulmonary inflammation after segmental allergen challenge using turbo-inversion recovery-magnitude magnetic resonance imaging. Am J Respir Crit Care Med. 2014 Mar 15;189(6):650-7. doi: 10.1164/rccm.201310-1825OCT
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