Publikationen

Klinische Pharmakokinetik

• Zeitlinger M, Schwameis R, Burian A, Burian B, Matzneller P, Müller M, Wicha WW, Strickmann DB, Prince W. Simultaneous assessment of the pharmacokinetics of a pleuromutilin, lefamulin, in plasma, soft tissues and pulmonary epithelial lining fluid. J Antimicrob Chemother. 2016 Jan 7. [Epub ahead of print] 
• Bauer M, Karch R, Zeitlinger M, Liu J, Koepp MJ, Asselin MC, Sisodiya SM, Hainfellner JA, Wadsak W, Mitterhauser M, Müller M, Pataraia E, Langer O. In vivo P-glycoprotein function before and after epilepsy surgery. Neurology. 2014 Oct 7;83(15):1326-31.</pre>
• Wressnigg N, Pöllabauer EM, Aichinger G, Portsmouth D, Löw-Baselli A, Fritsch S, Livey I, Crowe BA, Schwendinger M, Brühl P, Pilz A, Dvorak T, Singer J, Firth C, Luft B, Schmitt B, Zeitlinger M, Müller M, Kollaritsch H, Paulke-Korinek M, Esen M, Kremsner PG, Ehrlich HJ, Barrett PN. Safety and immunogenicity of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomised, dose-escalation phase 1/2 trial. Lancet Infect Dis. 13(8):680-689 (2013)
• Bauer M, Zeitlinger M, Karch R, Matzneller P, Stanek J, Jäger W, Böhmdorfer M, Wadsak W, Mitterhauser M, Bankstahl JP, Löscher W, Koepp M, Kuntner C, Müller M, Langer O. Pgp-Mediated Interaction Between (R)-[(11)C]Verapamil and Tariquidar at the Human Blood-Brain Barrier: A Comparison With Rat Data. Clin Pharmacol Ther. Clin Pharmacol Ther. 91(2):227-233 (2012)
• Wagner CC, Simpson M, Zeitlinger M, Bauer M, Karch R, Abrahim A, Feurstein T, Schütz M, Kletter K, Müller M, Lappin G, Langer O. A Combined Accelerator Mass Spectrometry-Positron Emission Tomography Human Microdose Study with 14C- and11C-Labelled Verapamil. Clin Pharmacokinet. 50(2):111-120 (2011)  
• Ehrlich HJ, Müller M, Fritsch S, Zeitlinger M, Berezuk G, Löw-Baselli A, van der Velden MV, Pöllabauer EM, Maritsch F, Pavlova BG, Tambyah PA, Oh HM, Montomoli E, Kistner O, Noel Barrett P. A Cell Culture (Vero)-Derived H5N1 Whole-Virus Vaccine Induces Cross-Reactive Memory Responses. J Infect Dis. 200(7):1113-1118 (2009)
• Bauer M, Langer O, Dal Bianco P, Karch R, Brunner M, Abrahim A, Lanzenberger R, Hofmann A, Joukhadar C, Carminati P, Ghirardi O, Piovesan P, Forloni G, Corrado M, Lods N,  Dudczak R, Auff E, Kletter K and Müller M. A positron emission tomography microdosing study with a potential antiamyloid drug in healthy volunteers and patients with Alzheimer´s disease. Clin Pharmacol Ther 80(3):216-227 (2006)
• Zeitlinger MA, Derendorf H, Mouton JW, Cars O, Craig WA, Andes D, Theuretzbacher U. Protein binding - do we ever learn? Antimicrob Agents Chemother. 55(7):3067-3074 (2011)
• Valentin al Jalali, Peter Matzneller, Anh Duc Pham, Wisse van Os, Michael Wölfl-Duchek, Maria Sanz-Codina, Andreas Vychytil, Birgit Reiter, Thomas Stimpfl, Markus Zeitlinger. Plasma and intraperitoneal pharmacokinetics of ceftazidime/avibactam in peritoneal dialysis patients. Clinical Microbiology and Infection, Volume 29, Issue 9, 2023, Pages 1196.e1-1196.e7, ISSN 1198-743X, https://doi.org/10.1016/j.cmi.2023.06.002.
• Maria Sanz-Codina, Wisse van Os, Anh Duc Pham, Anselm Jorda, Michael Wölf-Duchek, Felix Bergmann, Edith Lackner, Constantin Lier, J G Coen van Hasselt, Iris K Minichmayr, Christoph Dorn, Markus Zeitlinger, Valentin al Jalali, Target-site cefiderocol pharmacokinetics in soft tissues of healthy volunteers, Journal of Antimicrobial Chemotherapy, Volume 79, Issue 12, December 2024, Pages 3281–3288, https://doi.org/10.1093/jac/dkae359
• Bischof T, Al Jalali V, Zeitlinger M, Jorda A, Hana M, Singeorzan KN, Riesenhuber N, Stemer G, Schoergenhofer C. Chat GPT vs. Clinical Decision Support Systems in the Analysis of Drug-Drug Interactions. Clin Pharmacol Ther. 2025 Apr;117(4):1142-1147. doi: 10.1002/cpt.3585. Epub 2025 Feb 11. PMID: 39935064; PMCID: PMC11924163.
• Model-informed precision dosing: State of the art and future perspectives. Minichmayr IK, Dreesen E, Centanni M, Wang Z, Hoffert Y, Friberg LE, Wicha SG. Adv Drug Deliv Rev. 2024 Dec;215:115421. doi: 10.1016/j.addr.2024.115421. Epub 2024 Aug 17. PMID: 39159868
• Distribution of Bevacizumab into the Cerebrospinal Fluid of Children and Adolescents with Recurrent Brain Tumors. Minichmayr IK, Knaack U, Gojo J, Senfter D, Haberler C, Azizi AA, Mayr L, Zeitlinger M, Peyrl A. Paediatr Drugs. 2024 Jul;26(4):429-440. doi: 10.1007/s40272-024-00624-y. Epub 2024 Apr 8. PMID: 38587585 Free PMC article.
• Impact of continuous-infusion meropenem degradation and infusion bag changes on bacterial killing of Pseudomonas aeruginosa based on model-informed translation. Minichmayr IK, Friberg LE. Int J Antimicrob Agents. 2024 Aug;64(2):107236. doi: 10.1016/j.ijantimicag.2024.107236. Epub 2024 Jun 6. PMID: 38851463 Free article.

Kardiovaskuläre Pharmakologie

• A Randomized Phase 2 Trial of Felzartamab in Antibody-Mediated Rejection. Mayer KA, Schrezenmeier E, Diebold M, Halloran PF, Schatzl M, Schranz S, Haindl S, Kasbohm S, Kainz A, Eskandary F, Doberer K, Patel UD, Dudani JS, Regele H, Kozakowski N, Kläger J, Boxhammer R, Amann K, Puchhammer-Stöckl E, Vietzen H, Beck J, Schütz E, Akifova A, Firbas C, Gilbert HN, Osmanodja B, Halleck F, Jilma B, Budde K, Böhmig GA., N Engl J Med. 2024 Jul 11;391(2):122-132. doi: 10.1056/NEJMoa2400763. Epub 2024 May 25.
  PMID: 38804514 Clinical Trial.

• Safety and Efficacy of ApTOLL in Patients With Ischemic Stroke Undergoing Endovascular Treatment: A Phase 1/2 Randomized Clinical Trial. Hernández-Jiménez M, Abad-Santos F, Cotgreave I, Gallego J, Jilma B, Flores A, Jovin TG, Vivancos J, Hernández-Pérez M, Molina CA, Montaner J, Casariego J, Dalsgaard M, Liebeskind DS, Cobo E, Castellanos M, Portela PC, Masjuán J, Moniche F, Tembl JI, Terceño Izaga M, Arenillas JF, Callejas P, Olivot JM, Calviere L, Henon H, Mazighi M, Piñeiro D, Pugliese M, González VM, Moro MA, Garcia-Tornel A, Lizasoain I, Ribo M. JAMA Neurol. 2023 Aug 1;80(8):779-788. doi: 10.1001/jamaneurol.2023.1660.
  PMID: 37338893 Free PMC article. Clinical Trial.

• Efficacy and safety of asunercept, a CD95L-selective inhibitor, in hospitalised patients with moderate-to-severe COVID-19: ASUNCTIS, a multicentre, randomised, open-label, controlled, phase 2 trial. Ruiz Seco MP, Paño Pardo JR, Schoergenhofer C, Dings C, Lehr T, Herth F, Krendyukov A, Straub C, Kappler M, Jilma B, Fricke H, Pardo J, de Miguel D, Thiemann M, Bergmann M, Walczak H, Hoeger T. EClinicalMedicine. 2024 Oct 24;77:102879. doi: 10.1016/j.eclinm.2024.102879. eCollection 2024 Nov.
  PMID: 39513186 Free PMC article

• Pharmacokinetics and pharmacodynamics of low doses of recombinant tissue plasminogen activator to establish a model for biosimilarity comparisons. Derhaschnig U, Buchtele N, Steiner MM, Drucker C, Firbas C, Schörgenhofer C, Gelbenegger G, König F, Jilma B, Kovacevic Miljevic KD. Res Pract Thromb Haemost. 2024 Jul 22;8(6):102518. doi: 10.1016/j.rpth.2024.102518. eCollection 2024 Aug.

• Oral anticoagulant therapy and outcome in patients with stroke. A retrospective nation-wide cohort study in Austria 2012-2017. Preinreich J, Sheikh Rezaei S, Mittlböck M, Greisenegger S, Reichardt B, Wolzt M. Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1332-1338. doi: 10.1002/pds.5296. Epub 2021 Jun 3.
• Topically administered purified clinoptilolite-tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial. Deinsberger J, Marquart E, Nizet S, Meisslitzer C, Tschegg C, Uspenska K, Gouya G, Niederdöckl J, Freissmuth M, Wolzt M, Weber B. Wound Repair Regen. 2022 Mar;30(2):198-209. doi: 10.1111/wrr.12991. Epub 2022 Jan 27.
• Open-label phase II study evaluating safety and efficacy of the non-steroidal farnesoid X receptor agonist PX-104 in non-alcoholic fatty liver disease. Traussnigg S, Halilbasic E, Hofer H, Munda P, Stojakovic T, Fauler G, Kashofer K, Krssak M, Wolzt M, Trauner M. Wien Klin Wochenschr. 2021 May;133(9-10):441-451. doi: 10.1007/s00508-020-01735-5. Epub 2020 Sep 15.
• Dose-dependent naloxone-induced morphine withdrawal symptoms in opioid-dependent males-a double-blinded, randomized study. Weisshaar S, Brandt L, Litschauer B, Sheik-Rezaei S, Moser L, Nirnberger G, Kühberger E, Bauer U, Firbas C, Gouya G, Wolzt M, Fischer G. Br J Clin Pharmacol. 2020 Aug;86(8):1610-1619. doi: 10.1111/bcp.14271. Epub 2020 Mar 20.
• Electrical Stimulation of the Greater Auricular Nerve to Reduce Postoperative Atrial Fibrillation. Andreas M, Arzl P, Mitterbauer A, Ballarini NM, Kainz FM, Kocher A, Laufer G, Wolzt M. Circ Arrhythm Electrophysiol. 2019 Oct;12(10):e007711. doi: 10.1161/CIRCEP.119.007711. Epub 2019 Oct
• Interleaved ³¹ P MRS/¹ H ASL for analysis of metabolic and functional heterogeneity along human lower leg muscles at 7T. Niess F, Schmid AI, Bogner W, Wolzt M, Carlier P, Trattnig S, Moser E, Meyerspeer M. Magn Reson Med. 2020 Jun;83(6):1909-1919. doi: 10.1002/mrm.28088. Epub 2019 Dec 17.
• Intravenous Heme Arginate Induces HO-1 (Heme Oxygenase-1) in the Human Heart. Andreas M, Oeser C, Kainz FM, Shabanian S, Aref T, Bilban M, Messner B, Heidtmann J, Laufer G, Kocher A, Wolzt M. Arterioscler Thromb Vasc Biol. 2018 Nov;38(11):2755-2762. doi: 10.1161/ATVBAHA.118.311832.
• NLC versus nanoemulsions: Effect on physiological skin parameters during regular in vivo application and impact on drug penetration. Wolf M, Klang V, Stojcic T, Fuchs C, Wolzt M, Valenta C. Int J Pharm. 2018 Oct 5;549(1-2):343-351. doi: 10.1016/j.ijpharm.2018.08.007. Epub 2018 Aug 9.
• Atorvastatin combined with ticagrelor prevent ischemia-reperfusion induced vascular endothelial dysfunction in healthy young males – A randomized, placebo-controlled, double-blinded study. Weisshaar S, Litschauer B, Kerbel T, Wolzt M. Int J Cardiol. 2018 Mar 15;255:1-7. doi: 10.1016/j.ijcard.2017.12.067. Epub 2017 Dec 24.

Ophthalmo Pharmakologie

• Pai V, Janku P, Lindner T, Graf U, Schmetterer L, Garhöfer G, Schmidl D. A New Approach to Retinal Oxygen Extraction Measurement Based on Laser Speckle Flowgraphy and Retinal Oximetry. Transl Vis Sci Technol. 2024 Dec 2;13(12):12. doi: 10.1167/tvst.13.12.12. PMID: 39661379; PMCID: PMC11636657.

• Chua J, Tan B, Wong D, Garhöfer G, Liew XW, Popa-Cherecheanu A, Loong Chin CW, Milea D, Li-Hsian Chen C, Schmetterer L. Optical coherence tomography angiography of the retina and choroid in systemic diseases. Prog Retin Eye Res. 2024 Nov;103:101292. doi: 10.1016/j.preteyeres.2024.101292. Epub 2024 Aug 30. PMID: 39218142.

• Schmidl D, Hommer N, Kallab M, Schlatter A, Nadvornik C, Obermayr F, Sperl S, Daniels EJ, Garhöfer G. Safety and Tolerability of KIO-101 Eye Drops in Healthy Volunteers and Patients with Ocular Surface Disease-A Phase I Study. Pharmaceutics. 2024 Mar 5;16(3):367. doi: 10.3390/pharmaceutics16030367. PMID: 38543260; PMCID: PMC10974994.

• Hommer N, Kallab M, Schlatter A, Howorka K, Werkmeister RM, Schmidl D, Schmetterer L, Garhöfer G. Retinal Oxygen Metabolism in Patients With Type 2 Diabetes and Different Stages of Diabetic Retinopathy. Diabetes. 2022 Dec 1;71(12):2677-2684. doi: 10.2337/db22-0219. PMID: 36107468; PMCID: PMC9862478.

• Kallab M, Hommer N, Schlatter A, Chua J, Tan B, Schmidl D, Hirn C, Findl O, Schmetterer L, Garhöfer G, Wong D. Combining vascular and nerve fiber layer thickness measurements to model glaucomatous focal visual field loss. Ann N Y Acad Sci. 2022 May;1511(1):133-141. doi: 10.1111/nyas.14732. Epub 2022 Jan 14. PMID: 35029314; PMCID: PMC9305098.

• Oral anticoagulant therapy and outcome in patients with stroke. A retrospective nation-wide cohort study in Austria 2012-2017. Preinreich J, Sheikh Rezaei S, Mittlböck M, Greisenegger S, Reichardt B, Wolzt M. Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1332-1338. doi: 10.1002/pds.5296. Epub 2021 Jun 3.
• Topically administered purified clinoptilolite-tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial. Deinsberger J, Marquart E, Nizet S, Meisslitzer C, Tschegg C, Uspenska K, Gouya G, Niederdöckl J, Freissmuth M, Wolzt M, Weber B. Wound Repair Regen. 2022 Mar;30(2):198-209. doi: 10.1111/wrr.12991. Epub 2022 Jan 27.
• Open-label phase II study evaluating safety and efficacy of the non-steroidal farnesoid X receptor agonist PX-104 in non-alcoholic fatty liver disease. Traussnigg S, Halilbasic E, Hofer H, Munda P, Stojakovic T, Fauler G, Kashofer K, Krssak M, Wolzt M, Trauner M. Wien Klin Wochenschr. 2021 May;133(9-10):441-451. doi: 10.1007/s00508-020-01735-5. Epub 2020 Sep 15.
• Dose-dependent naloxone-induced morphine withdrawal symptoms in opioid-dependent males-a double-blinded, randomized study. Weisshaar S, Brandt L, Litschauer B, Sheik-Rezaei S, Moser L, Nirnberger G, Kühberger E, Bauer U, Firbas C, Gouya G, Wolzt M, Fischer G. Br J Clin Pharmacol. 2020 Aug;86(8):1610-1619. doi: 10.1111/bcp.14271. Epub 2020 Mar 20.
• Electrical Stimulation of the Greater Auricular Nerve to Reduce Postoperative Atrial Fibrillation. Andreas M, Arzl P, Mitterbauer A, Ballarini NM, Kainz FM, Kocher A, Laufer G, Wolzt M. Circ Arrhythm Electrophysiol. 2019 Oct;12(10):e007711. doi: 10.1161/CIRCEP.119.007711. Epub 2019 Oct
• Interleaved ³¹ P MRS/¹ H ASL for analysis of metabolic and functional heterogeneity along human lower leg muscles at 7T. Niess F, Schmid AI, Bogner W, Wolzt M, Carlier P, Trattnig S, Moser E, Meyerspeer M. Magn Reson Med. 2020 Jun;83(6):1909-1919. doi: 10.1002/mrm.28088. Epub 2019 Dec 17.

Hämatologie und Immunologie

• Ay C, Pabinger I, Kovacevic KD, Gelbenegger G, Schörgenhofer C, Quehenberger P, Jilma-Stohlawetz P, Sunder-Plassman R, Gilbert JC, Zhu S, Jilma B, Derhaschnig U. The VWF binding aptamer rondoraptivon pegol increases platelet counts and VWF/FVIII in type 2B von Willebrand disease. Blood Adv. 2022 Sep 27;6(18):5467-5476. doi: 10.1182/bloodadvances.2022007805.
• Kovacevic KD, Grafeneder J, Schörgenhofer C, Gelbenegger G, Gager G, Firbas C, Quehenberger P, Jilma-Stohlawetz P, Bileck A, Zhu S, Gilbert JC, Beliveau M, Jilma B, Derhaschnig U. The von Willebrand factor A-1 domain binding aptamer BT200 elevates plasma levels of von Willebrand factor and factor VIII: a first-in-human trial. Haematologica. 2022 Sep 1;107(9):2121-2132. doi: 10.3324/haematol.2021.279948. 
• Röth A, Barcellini W, D'Sa S, Miyakawa Y, Broome CM, Michel M, Kuter DJ, Jilma B, Tvedt THA, Fruebis J, Jiang X, Lin S, Reuter C, Morales-Arias J, Hobbs W, Berentsen S. Sutimlimab in Cold Agglutinin Disease. N Engl J Med. 2021 Apr 8;384(14):1323-1334. doi: 10.1056/NEJMoa2027760. 
• Gludovacz E, Schuetzenberger K, Resch M, Tillmann K, Petroczi K, Schosserer M, Vondra S, Vakal S, Klanert G, Pollheimer J, Salminen TA, Jilma B, Borth N, Boehm T. Heparin-binding motif mutations of human diamine oxidase allow the development of a first-in-class histamine-degrading biopharmaceutical. Elife. 2021 Sep 3;10:e68542. doi: 10.7554/eLife.68542. elife-68542.pdf (nih.gov)
• Doberer K, Duerr M, Halloran PF, Eskandary F, Budde K, Regele H, Reeve J, Borski A, Kozakowski N, Reindl-Schwaighofer R, Waiser J, Lachmann N, Schranz S, Firbas C, Mühlbacher J, Gelbenegger G, Perkmann T, Wahrmann M, Kainz A, Ristl R, Halleck F, Bond G, Chong E, Jilma B, Böhmig GA. A Randomized Clinical Trial of Anti-IL-6 Antibody Clazakizumab in Late Antibody-Mediated Kidney Transplant Rejection. J Am Soc Nephrol. 2021 Mar;32(3):708-722. doi: 10.1681/ASN.2020071106708.full.pdf (asnjournals.org)
• Schoergenhofer C, Jilma B, Stimpfl T, Karolyi M, Zoufaly A.Pharmacokinetics of Lopinavir and Ritonavir in Patients Hospitalized With Coronavirus Disease 2019 (COVID-19). Ann Intern Med. 2020 Oct 20;173(8):670-672. doi: 10.7326/M20-1550. Epub 2020 May 12.PMID: 32422065 Free PMC article. Pharmacokinetics of Lopinavir and Ritonavir in Patients Hospitalized With Coronavirus Disease 2019 (COVID-19) | Annals of Internal Medicine (acpjournals.org)

• Jäger U, D'Sa S, Schörgenhofer C, Bartko J, Derhaschnig U, Sillaber C, Jilma-Stohlawetz P, Fillitz M, Schenk T, Patou G, Panicker S, Parry GC, Gilbert JC, Jilma B. Inhibition of complement C1s improves severe hemolytic anemia in cold agglutinin disease: a first-in-human trial. Blood. 2019 Feb 28;133(9):893-901. doi: 10.1182/blood-2018-06-856930 
• Peyvandi F, Scully M, Kremer Hovinga JA, Cataland S, Knöbl P, Wu H, Artoni A, Westwood JP, Mansouri Taleghani M, Jilma B, Callewaert F, Ulrichts H, Duby C, Tersago D; TITAN Investigators. Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura. N Engl J Med. 2016 Feb 11;374(6):511-22. doi: 10.1056/NEJMoa1505533.PMID: 26863353  Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura (nejm.org)

• Schwameis M, Roppenser B, Firbas C, Gruener CS, Model N, Stich N, Roetzer A, Buchtele N, Jilma B, Eibl MM. Safety, tolerability, and immunogenicity of a recombinant toxic shock syndrome toxin (rTSST)-1 variant vaccine: a randomised, double-blind, adjuvant-controlled, dose escalation first-in-man trial. Lancet Infect Dis. 2016 Sep;16(9):1036-1044. doi: 10.1016/S1473-3099(16)30115-3..
• Hobl EL, Stimpfl T, Ebner J, Schoergenhofer C, Derhaschnig U, Sunder-Plassmann R, Jilma-Stohlawetz P, Mannhalter C, Posch M, Jilma B. Morphine decreases clopidogrel concentrations and effects: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2014 Feb 25;63(7):630-635. doi: 10.1016/j.jacc.2013.10.068. Epub 2013 Dec 4. Morphine Decreases Clopidogrel Concentrations and Effects | Elsevier Enhanced Reader

Arzneimittelentwicklung und Gesundheitswesen

• Dal-Ré R, Bottieau E, Launay O, Rosendaal FR, Schwarzer-Daum B. Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries. CLINICAL TRIALS. 2024;0(0).

  https://journals.sagepub.com/doi/10.1177/17407745241238925

• Hans-Georg Eichler, Michael Kossmeier, Markus Zeitlinger, and Brigitte Schwarzer-Daum*. "Orphan drugs’ clinical uncertainty and prices: addressing allocative and technical inefficiencies in orphan drug reimbursement." FRONTIERS IN PHARMACOLOGY 14: 60. 26 January 2023

  https://doi.org/10.3389/fphar.2023.1074512

  *Corresponding Author

• Rafael Dal-Ré, MD, Prof Raphaël Porcher, PhD, Prof Frits R. Rosendaal, MD, Prof Brigitte Schwarzer-Daum, MD  Regulatory agencies disregard real-world effectiveness evidence on product labels beyond what is reasonable

  JOURNAL OF CLINICAL EPIDEMIOLOGY  November 09, 2022

  https://doi.org/10.1016/j.jclinepi.2022.11.007

• Hans-Georg Eichler, Mark Trusheim, Brigitte Schwarzer-Daum, Kay Larholt, Markus Zeitlinger, Martin Brunninger, Michael Sherman, David Strutton, Gigi Hirsch: Precision reimbursement for precision medicine: using real-world evidence to evolve from trial-and-project to track-and-pay to learn-and-predict

  CLINICAL PHARMACOLOGY & THERAPEUTICS 2022, 111(1): 52-62 https://doi:10.1002/cpt.2471

• Rafael Dal-Ré, Raphaël Porcher, Frits R Rosendaal, Brigitte Schwarzer-Daum: It is time to include real-world effectiveness data on medicinal product labels

  THE LANCET RESPIRATORY MEDICINE  Published: January 10, 2022 DOI: https://doi.org/10.1016/S2213-2600(22)00003-0

• Maria E. Sheean, Frauke Naumann-Winter, Giuseppe Capovilla, Maria Elisabeth Kalland, Eva Malikova, Segundo Mariz, Darius Matusevicius, Robert Nistico, Brigitte Schwarzer-Daum, Stelios Tsigkos, Kyriaki Tzogani, Kristina Larsson, Armando Magrelli and Violeta Stoyanova-Beninska:

  Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective

  FRONTIERS IN MEDICINE, 27 August 2021 https://doi.org/10.3389/fmed.2021.744625

• Rafael Dal-Ré, Linda-Gail Bekker, Christian Gluud, Søren Holm, Vivekanand Jha, Gregory A Poland, Frits R Rosendaal, Brigitte Schwarzer-Daum, Esperança Sevene, Halidou Tinto, Teck Chuan Voo, Nadarajah Sreeharan:  Ongoing and future COVID-19 vaccine clinical trials:  challenges and opportunities  LANCET INFECTIOUS DISEASES 2021 Published Online May 18, 2021

  DOI: https://doi.org/10.1016/S1473-3099(21)00263-2