Publications

Articles & Publications

Articles

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Neue Impulse bei klinischen Studien

Wirschaftsforum, 2024
Link: https://www.wirtschaftsforum.de/marco-gmbh-co-kg/neue-impulse-bei-klinischen-studien

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(Fehl-)Interpretation von p-Werten in klinischen Vergleichsstudien

PM QM 2021, Jahrgang 23 | Heft 2 | Juni
Link: PM_QM_2_2021_MW (PDF)

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Prozessmanagement zur Gewährleistung der Datenqualität in klinischen Prüfungen, PM QM 2020

Jahrgang 22 | Heft 1 | März
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Publications

Besides industrial cooperation, M.A.R.C.O. has co-authored and contributed to numerous publications with academic and other research institutions underlining the broad coverage of medical areas:
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Survey Study to Identify the Maximum Acceptable Numbers of 2 mm and 3 mm Mini-Tablets for Short-, Middle-, and Long-Term Treatments in Acutely and Chronically Sick Children of Different Age Groups Below 18 Years.

Wargenau M, Mutzke E, Spitzhorn LS, Reidemeister S, Klingmann I, Klingmann V. Pharmaceutics. 2025;17(7):834. Published 2025 Jun 26. doi:10.3390/pharmaceutics17070834
Link: https://www.mdpi.com/1999-4923/17/7/834

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Validating a composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population

Münch J, Schwarzwälder AL, Kloft C, Bosse HM, Wargenau M, Reidemeister S, Klingmann I, Klingmann V.
A randomized, open-label, single dose, cross-over study. Front Pharmacol. 2024 Aug 19;15:1436554. doi: 10.3389/fphar.2024.1436554. PMID: 39224774; PMCID: PMC11366573.
Link: https://pubmed.ncbi.nlm.nih.gov/39224774/

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A Semi-Mechanistic Population Pharmacokinetic Model of Noscapine in Healthy Subjects Considering Hepatic First-Pass Extraction and CYP2C9 Genotypes.

Chen Z, Taubert M, Chen C, Boland J, Dong Q, Bilal M, Dokos C, Wachall B, Wargenau M, Scheidel B, Wiesen MHJ, Schaeffeler E, Tremmel R, Schwab M, Fuhr U.
Drugs R D. 2024 Jun;24(2):187-199. doi: 10.1007/s40268-024-00466-6. Epub 2024 May 29. PMID: 38809387; PMCID: PMC11315837.
Link: https://pubmed.ncbi.nlm.nih.gov/38809387/

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Assessment of body mass-related covariates for rifampicin pharmacokinetics in healthy Caucasian volunteers

Bilal M, Ullah S, Jaehde U, Trueck C, Zaremba D, Wachall B, Wargenau M, Scheidel B, Wiesen MHJ, Gazzaz M, Chen C, Büsker S, Fuhr U, Taubert M, Dokos C. Eur J Clin Pharmacol. 2024 Sep;80(9):1271-1283. doi: 10.1007/s00228-024-03697-3. Epub 2024 May 9. PMID: 38722350; PMCID: PMC11303472.
Link: https://pubmed.ncbi.nlm.nih.gov/38722350/

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Double-blind, randomized, 8-week multicenter study of the efficacy and safety of STW 5-II versus placebo in functional dyspepsia

Vinson B, Fink C, Wargenau M, Talley NJ, Holtmann G.
JGH Open. 2024 May 2;8(5):e13054. doi: 10.1002/jgh3.13054. PMID: 38699471; PMCID: PMC11064020.
Link: https://pubmed.ncbi.nlm.nih.gov/38699471/

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Questionnaire Study to Investigate the Preferences of Children, Parents, and Healthcare Professionals for Different Formulations of Oral Medicinal Products

Wargenau M, Baase F, Eckardt K, Spitzhorn LS, Reidemeister S, Klingmann I, Klingmann V.
Pharmaceutics. 2024 Apr 8;16(4):515. doi: 10.3390/pharmaceutics16040515. PMID: 38675176; PMCID: PMC11054268.
Link: https://pubmed.ncbi.nlm.nih.gov/38675176/

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Efficacy and Safety of STW 5-II for Functional Dyspepsia Treatment: A Patient Data-Based Meta-Analysis

Andresen V, Shah A, Fink C, Rabini S, Wargenau M, Holtmann G.
Digestion. 2024;105(3):166-174. doi: 10.1159/000535672. Epub 2024 Jan 19. PMID: 38246134; PMCID: PMC11152030.
Link: https://pubmed.ncbi.nlm.nih.gov/38246134/

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Comparison of gastrointestinal adverse events between fast release tablets and regular acetylsalicylic acid (aspirin) galenics after short-term use: a meta-analysis of randomized clinical trials

Lanas A, Werz O, Mikhail E.
Inflammopharmacology. 2023 Oct;31(5):2369-2381. doi: 10.1007/s10787-023-01264-3. Epub 2023 Aug 21. PMID: 37603157; PMCID: PMC10518280.
Link: https://pubmed.ncbi.nlm.nih.gov/37603157/

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Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study

Münch J, Sessler I, Bosse HM, Wargenau M, Dreesen JD, Loforese G, Webb NJA, Sivasubramanian R, Reidemeister S, Lustenberger P, Klingmann V.
Pharmaceutics. 2023 Jun 14;15(6):1729. doi: 10.3390/pharmaceutics15061729. PMID: 37376177; PMCID: PMC10303492.
Link: https://pubmed.ncbi.nlm.nih.gov/37376177/

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How can we unleash the potential of external controls in clinical trials?

Schwarz P, Brockstedt E.
Drug Discov Today. 2023 Apr;28(4):103492. doi: 10.1016/j.drudis.2023.103492. Epub 2023 Jan 18. PMID: 36681236.
Link: https://pubmed.ncbi.nlm.nih.gov/36681236/

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The effect of exacerbations on lung density in α1-antitrypsin deficiency

Strange C, McElvaney NG, Vogelmeier CF, Marin-Galiano M, Buch-Haensel M, Zhang X, Chen Y, Vit O, Wencker M, Chapman KR.
ERJ Open Res. 2023 Mar 13;9(2):00457-2022. doi: 10.1183/23120541.00457-2022. PMID: 36923570; PMCID: PMC10009703.
Link: https://pubmed.ncbi.nlm.nih.gov/36923570/

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A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population

Wargenau M, Reidemeister S, Klingmann I, Klingmann V.
Ther Innov Regul Sci. 2022 Nov;56(6):903-909. doi: 10.1007/s43441-022-00406-z. Epub 2022 Apr 26. PMID: 35471561; PMCID: PMC9492601.
Link: https://pubmed.ncbi.nlm.nih.gov/35471561/

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Riociguat in pulmonary hypertension and heart failure with preserved ejection fraction: the haemoDYNAMIC trial

Dachs TM, Duca F, Rettl R, Binder-Rodriguez C, Dalos D, Ligios LC, Kammerlander A, Grünig E, Pretsch I, Steringer-Mascherbauer R, Ablasser K, Wargenau M, Mascherbauer J, Lang IM, Hengstenberg C, Badr-Eslam R, Kastner J, Bonderman D.
Eur Heart J. 2022 Sep 21;43(36):3402-3413. doi: 10.1093/eurheartj/ehac389. PMID: 35909264; PMCID: PMC9492239.
Link: https://pubmed.ncbi.nlm.nih.gov/35909264/

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Acceptability of small-sized oblong tablets in comparison to syrup and mini-tablets in infants and toddlers: A randomized controlled trial

Münch J, Meissner T, Mayatepek E, Wargenau M, Breitkreutz J, Bosse HM, Klingmann V.
Eur J Pharm Biopharm. 2021 Sep;166:126-134. doi: 10.1016/j.ejpb.2021.06.007. Epub 2021 Jun 19. PMID: 34153451.
Link: https://pubmed.ncbi.nlm.nih.gov/34153451/

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Pharmacokinetics and Safety of the Selective Progesterone Receptor Modulator Vilaprisan in Chinese Healthy Postmenopausal Women

Liu H, Jiang J, Chen Z, Zhang Y, Li J, Hoechel J, Rohde B, Zimmermann T, Schultze-Mosgau MH.
Clin Pharmacol Drug Dev. 2021 May;10(5):486-493. doi: 10.1002/cpdd.851. Epub 2020 Jul 27. PMID: 32716091; PMCID: PMC8247050.
Link: https://pubmed.ncbi.nlm.nih.gov/32716091/

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Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized controlled trial

Klingmann V, Pohly CE, Meissner T, Mayatepek E, Möltner A, Flunkert K, Breitkreutz J, Bosse HM.
Eur J Pharm Biopharm. 2020 Jun;151:239-245. doi: 10.1016/j.ejpb.2020.03.018. Epub 2020 Apr 26. PMID: 32348882.
Link: https://pubmed.ncbi.nlm.nih.gov/32348882/

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Effect on endometrial histology and pharmacokinetics of different dose regimens of progesterone vaginal pessaries, in comparison with progesterone vaginal gel and placebo

Duijkers IJM, Klingmann I, Prinz R, Wargenau M, Hrafnsdottir S, Magnusdottir TB, Klipping C.
Hum Reprod. 2018 Nov 1;33(11):2131-2140. doi: 10.1093/humrep/dey288. PMID: 30265306.
Link: https://pubmed.ncbi.nlm.nih.gov/30265306/

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Adapted Acoustic CR Neuromodulation in Patients With Chronic Tonal Tinnitus and Hearing Loss

Wurzer H, Hauptmann C.
Front Med (Lausanne). 2018 Oct 10;5:288. doi: 10.3389/fmed.2018.00288. PMID: 30364120; PMCID: PMC6192374.
Link: https://pubmed.ncbi.nlm.nih.gov/30364120/

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Blood glucose response after oral intake of lactulose in healthy volunteers: A randomized, controlled, cross-over study

Steudle J, Schön C, Wargenau M, Pauly L, Schwejda-Güttes S, Gaigg B, Kuchinka-Koch A, Stover JF.
World J Gastrointest Pharmacol Ther. 2018 Aug 7;9(3):22-30. doi: 10.4292/wjgpt.v9.i3.22. PMID: 30090645; PMCID: PMC6081387.
LinK: https://pubmed.ncbi.nlm.nih.gov/30090645/

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Evaluation of the pharmacoDYNAMIC effects of riociguat in subjects with pulmonary hypertension and heart failure with preserved ejection fraction : Study protocol for a randomized controlled trial

Mascherbauer J, Grünig E, Halank M, Hohenforst-Schmidt W, Kammerlander AA, Pretsch I, Steringer-Mascherbauer R, Ulrich S, Lang IM, Wargenau M, Frey R, Bonderman D.
Wien Klin Wochenschr. 2016 Dec;128(23-24):882-889. doi: 10.1007/s00508-016-1068-8. Epub 2016 Sep 2. PMID: 27590259; PMCID: PMC5161763.
Link: https://pubmed.ncbi.nlm.nih.gov/27590259/

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Gastrointestinal Safety of Aspirin for a High-Dose, Multiple-Day Treatment Regimen: A Meta-Analysis of Three Randomized Controlled Trials

Forder S, Voelker M, Lanas A.
Drugs R D. 2016 Sep;16(3):263-269. doi: 10.1007/s40268-016-0138-8. PMID: 27449765; PMCID: PMC5045830.
Link: https://pubmed.ncbi.nlm.nih.gov/27449765/

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A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease

Filippatos G, Anker SD, Böhm M, Gheorghiade M, Køber L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B.
Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29. PMID: 27130705; PMCID: PMC4946749.
Link: https://pubmed.ncbi.nlm.nih.gov/27130705/

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Pre-differentiation of mesenchymal stromal cells in combination with a microstructured nerve guide supports peripheral nerve regeneration in the rat sciatic nerve model

Boecker AH, van Neerven SG, Scheffel J, Tank J, Altinova H, Seidensticker K, Deumens R, Tolba R, Weis J, Brook GA, Pallua N, Bozkurt A.
Eur J Neurosci. 2016 Feb;43(3):404-16. doi: 10.1111/ejn.13052. Epub 2015 Oct 5. PMID: 26296589.
Link: https://pubmed.ncbi.nlm.nih.gov/26296589/

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Pharmacokinetics and pharmacogenetics of capecitabine and its metabolites following replicate administration of two 500 mg tablet formulations

Queckenberg C, Erlinghagen V, Baken BC, Van Os SH, Wargenau M, Kubeš V, Peroutka R, Novotný V, Fuhr U.
Cancer Chemother Pharmacol. 2015 Nov;76(5):1081-91. doi: 10.1007/s00280-015-2840-6. Epub 2015 Aug 5. PMID: 26242222.
Link: https://pubmed.ncbi.nlm.nih.gov/26242222/

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Sucrose-Formulated Recombinant Factor VIII Dosing Flexibility in Prophylaxis Regimens: Experience from Postmarketing Surveillance Studies

Humphries TJ, Rauchensteiner S, Tückmantel C, Pieper A, Maas Enriquez M, Mathew P.
Adv Hematol. 2015;2015:431268. doi: 10.1155/2015/431268. Epub 2015 Aug 19. PMID: 26356675; PMCID: PMC4556870.
Link: https://pubmed.ncbi.nlm.nih.gov/26356675/

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The impact of hydroxyethyl starches in cardiac surgery: a meta-analysis

Jacob M, Fellahi JL, Chappell D, Kurz A.
Crit Care. 2014 Dec 4;18(6):656. doi: 10.1186/s13054-014-0656-0. PMID: 25475406; PMCID: PMC4301454.
Link: https://pubmed.ncbi.nlm.nih.gov/25475406/

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Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal background therapy with beta-blockers: a 12-week, randomized, double-blind, placebo-controlled trial

Münzel T, Meinertz T, Tebbe U, Schneider HT, Stalleicken D, Wargenau M, Gori T, Klingmann I; CLEOPATRA Study Investigators.
Eur Heart J. 2014 Apr;35(14):895-903. doi: 10.1093/eurheartj/eht384. Epub 2013 Sep 26. PMID: 24071762; PMCID: PMC3977134.
Link: https://pubmed.ncbi.nlm.nih.gov/24071762/

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Pharmacokinetics and safety of 6 % hydroxyethyl starch 130/0.4 in healthy male volunteers of Japanese ethnicity after single infusion of 500 ml solution

Yamakage M, Bepperling F, Wargenau M, Miyao H.
J Anesth. 2012 Dec;26(6):851-7. doi: 10.1007/s00540-012-1430-6. Epub 2012 Jun 23. PMID: 22729229.
Link: https://pubmed.ncbi.nlm.nih.gov/22729229/

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Propofol anesthesia in spontaneously breathing children undergoing magnetic resonance imaging: comparison of two propofol emulsions

Gutmann A, Pessenbacher K, Gschanes A, Eggenreich U, Wargenau M, Toller W.
Paediatr Anaesth. 2006 Mar;16(3):266-74. doi: 10.1111/j.1460-9592.2005.01777.x. PMID: 16490090.
Link: https://pubmed.ncbi.nlm.nih.gov/16490090/

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The pharmacokinetics and tolerability of an intravenous infusion of the new hydroxyethyl starch 130/0.4 (6%, 500 mL) in mild-to-severe renal impairment

Jungheinrich C, Scharpf R, Wargenau M, Bepperling F, Baron JF.
Anesth Analg. 2002 Sep;95(3):544-51, table of contents. doi: 10.1097/00000539-200209000-00007. PMID: 12198032.
Link: https://pubmed.ncbi.nlm.nih.gov/12198032/

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Dosage form-related food interaction observed in a marketed once-daily nifedipine formulation after a high-fat American breakfast

Schug BS, Brendel E, Wonnemann M, Wolf D, Wargenau M, Dingler A, Blume HH.
Eur J Clin Pharmacol. 2002 May;58(2):119-25. doi: 10.1007/s00228-002-0444-7. Epub 2002 Apr 17. PMID: 12012144.
Link: https://pubmed.ncbi.nlm.nih.gov/12012144/

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Formulation-dependent food effects demonstrated for nifedipine modified-release preparations marketed in the European Union

Schug BS, Brendel E, Wolf D, Wonnemann M, Wargenau M, Blume HH.
Eur J Pharm Sci. 2002 Apr;15(3):279-85. doi: 10.1016/s0928-0987(02)00008-8. PMID: 11923060.
Link: https://pubmed.ncbi.nlm.nih.gov/11923060/

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