The publications and presentations of the Austrian Medicines and Medical Devices Agency are available in the AGES Research Portal.

2015

Baumgärtel, Christoph; Godman, Brian; Editorial, Are generic immunosuppressants safe and effective?

British Medical Journal, BMJ 2015;350:h3248

Baumgärtel, Christoph; Godman, Brian; Bioequivalence of narrow therapeutic index drugs and immunosuppressives.

Generics and Biosimilars Initiative Journal, GaBI Journal; 2015;4 (4):12.

Baumgärtel, Christoph; Hyposensibilisierung - keine Gesundheitsgefahr durch Aluminium.

Pädiatrische Praxis; 2015;84:4624

Baumgärtel, Christoph; Status quo der gesetzlichen Rahmenbedingungen - Zulassung und Anwendung von Biosimilars in Österreich.

Jatros, Hämatologie & Onkologie, 2015; 3/15,112-3

Baumgärtel, Christoph; Status quo der gesetzlichen Rahmenbedingungen - Zulassung und Anwendung von Biosimilars in Österreich.

Jatros, Orthopädie & Rheumatologie, 2015; 3/15,56-8

Baumgärtel, Christoph; FDA warnt vor Bradykardien - Gleichzeitige Gabe von Amiodaron und neuen Hepatitis-C-Therapeutika, Bedeutung der Warnhinweise für Österreich.

Medical Tribune; 2015;16:4

Baumgärtel, Christoph; Substantial savings with generics in Austria - and still room for more.

Generic and Biosimilar Initiative GaBI Journal; 2015;4(3)

Baumgärtel, Christoph; Generika in Österreich und Bedeutung für das Gesundheitssystem; 2015; ISBN: 978-3-639-49126-5

Baumgärtel, Christoph; Codein bei Kindern, AGES warnt vor Anwendungsfehlern; Pharmaceutical Tribune; 2015;3:23

Baumgärtel, Christoph; Gazda-Pleban, Katharina; Generics authorization - groundbreaking regulatory approach to closer international cooperation on the rise - IGDRP, Generics and Biosimilars Initiative Journal, GaBI Journal; 2015;4(1):48.

Heinze, Georg; Hronsky, Milan; Baumgärtel, Christoph; Reichardt; Berthold; Müllner, Marcus; Bucsics, Anna; Potential Savings in Prescription Drug Costs for Hypertension, Hyperlipidemia and Diabetes Mellitus by Equivalent Drug Substitution in Austria. A Nationwide Cohort Study.

Appl Health Econ Health Policy. 2015 Apr;13(2):193-205

Heinze, Georg; Jandeck, Lisanne; Hronsky, Milan; Baumgärtel, Christoph; Reichardt; Berthold; Bucsics, Anna; Müllner, Marcus; Winkelmayer, Wolfgang; Prevalence and determinants of unintended double medication of antihypertensive, lipid-lowering, and hypoglycemic drugs in Austria. A nationwide cohort study.

Pharmacoepidemiology and Drug Safety. 2016 Jan;25(1):90-9

Godman, Brian; Wilcock, Michael; Martin Andrew; Bryson Scott; Baumgärtel, Christoph; Generic Pregabalin. Current Situation and Implications for Health Authorities, Generic and Biosimilar Manufacturers in the Future.

Generic and Biosimilar Initiative, GaBI journal; 2015;4(3),125-35

Kisser, A.; Kirisits, Andreas; Endovaskuläre Embolisation unrupturierter intrakranieller Aneurysmen mit Flow Divertern.

Decision Support Document 83; MÄR/2015; (2015)Vienna; ISSN: online: 1998-0469

Moser, Judith; Farkouh, A.; Mayer, Christian; Anour, Rene; (2015); Biosimilars - zukunftsträchtige Nachahmung auf hohem Niveau.

JATROS; (3/15) : 22-24; 18/MÄR - 19/MÄR/2015; Quelle: Forum Pharma: Biosimilars

Rendi-Wagner, Pamela; Klein, Jean-Paul; Falb, Petra; Feierabend, Petra; Holzmann, Heidemarie; Kitchen, Maria; Kollaritsch, Herwig; Kreidl, Peter; Kundi, Michael; Palmisano, Georg; Tucek, Barbara; Wiedermann-Schmidt, Ursula; Zenz, Werner; Zwiauer, Karl; (2015); Impfplan Österreich 2015; 1-87; 19/JÄN/2015; ISBN. 978-3-902611-87-1

Salmikangas, Paula; Menezes-Ferreira, Margarida; Reischl, Ilona; Tsiftsoglou, Asterios; Kyselovic, Jan; Borg, John Joseph; Ruiz, Sol; Flory, Egbert; Trouvin, Jean-Hugues; Celis, Patrick; Ancans, Janis; Timon, Marcos; Pante, Guido; Sladowski, Dariusz; Lipnik-Stangelj, Metoda; Schneider, Christian K.; (2015); Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.

Regenerative Medicine; 10 (1): 65-78

Stain, Milena; (2015); Neue Anti-Adipositas Präparate in Europa/Österreich. Neuzulassungen 2015.

Universum Innere Medizin; (09/15)

Wiedermann-Schmidt, Ursula; Kollaritsch, Herwig; Kundi, Michael; Falb, Petra; Godnic-Cvar, Jasminka; Hallström, Ingrid; Harbich, Harald; Höltl, Eva; Holzmann, Heidemarie; Kitchen, Maria. Palmisano, Georg; Payer-Neundlinger, Gabriela; Pils, Marzena; Pospischil, Erich; Rath, Erwin; Rupp, Bernhard; Tucek, Barbara; Rendi-Wagner, Pamela; Zenz, Werner; Zwiauer, Karl; (2015).

Impfungen für Erwachsene im erwerbsfähigen Alter - Erläuterungen und Definitionen in Ergänzung zum Österreichischen Impfplan; 1-16; JÄN/2015

2014

Anour, Rene (2014); Biosimilars versus 'biobetters' - a regulator's perspective.

Generics and Biosimilars Initiative Journal (GaBI Journal); 34. gabi-journal.net/biosimilarsversus-biobetters-a-regulators-perspective.html

Bauer, Ronald (2014); Einfuhr und Verbringung von Arzneiwaren und Blutprodukten nach Österreich - Regelwerk für Warenströme aus EWR und Drittländern.

Pharmazeutische Medizin; Jahrgang 16 (2) : 117-121; JUN/2014

Bauernhofer, Thomas; Samonigg, Helmut; Regitnik, Peter; Weitzer Werner; Lileg, Brigitte; Waxenecker, Günter; Wiederkum Susanne; Kainer, Manuela; Schuster, Manfred; Loibner, Hans; Fido, Markus; Kircheis, Ralf; Nechansky, Andreas; Scientific Research Publishing (2014); Safety and Therapeutic Efficacy of the Lewis Y Carbohydrate Specific Humanized Antibody MB311 in Patients with Malignant Effusion.

Journal of Cancer Therapy; (5) : 28-37; JÄN/2014

Baumgärtel, Christoph (2014); Arzneimittelfälschungen aus dem Internet.

Österreichische Apothekerzeitung (ÖAZ); 68. Jg. (6) : 15-17; 17/mär/2014

Baumgärtel, Christoph (2014); Generika in Österreich und ihre Bedeutung für das Gesundheitssystem, AkademikerVerlag, ISBN: 978-3-639-49126-5

Baumgärtel, Christoph (2014); New product-specific bioequivalence guidance.

Generics and Biosimilars Initiative Journal (GaBI Journal); 3 (1):29

Baumgärtel, Christoph; Neuhauser, Jan (2014); New EU guidance for the evaluation of medicinal products with modified drug release will finished by the middle of 2014; Generics and Biosimilars Initiative Journal (GaBI Journal); 3 (2) : 99; 22/NOV/2014

Baumgärtel, Christoph; Unterkofler, Bernd (2014); Die EU-Arzneimittelfälschungsrichtlinie und der Internet (Versand-)handel sowie Auswirkungen auf Originale und Generika; Springer Verlag, Apotheker Plus; 25/MÄR/2014

Erben, Reinhold G.; Silva-Lima, Beatriz; Reischl, Ilona; Steinhoff, Gustav; Tiedemann, Gudrun; Dalemans, Wilfried; Vos, Alexander; Janssen, Rob T.A.; Le Blanc, Katarina; van Osch, Gerjo J.V.M.; Luyten, Frank P.; Mary Ann Liebert, Inc. (2014); White Paper on How to Go Forward with Cell-Based Advanced Therapies in Europe.

Tissue engineering; 20(19-20) : 2549-2554; OKT/2014

Godman, Brian; Malmström, Rickard E.; Diogene, Eduardo; Jayathissa, Sisira; McTaggart, Stuart; Cars, Thomas; Alvarez-Madrazo, Samantha; Baumgärtel, Christoph; Brzezinska, Anna; Bucsics, Anna; Campbell, Stephen; Eriksson, Irene; Finlayson, Alexander; Piessnegger, Jutta; Selke, Gisbert, Gustafsson, Lars L.; et al. (2014).

Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs.

Front. Pharmacol.; 5; JUN/2014 Huemer, Karl-Heinz; Wang, S.; Bar-Shalom D, Rose K. (2014); Paediatric Pharmaceutical Legislation and Ist Impact on Adult and Paediatric Drug Development. The EU View; Pediatric Formulations, AAPS Advances in the Pharmaceutical Sciences

Kisser, A.; Kirisits, Andreas; Literaturserver der Ludwig Boltzmann Gesellschaft (2014); Zytoreduktive Chirurgie und hypertherme intraperitoneale Chemotherapie bei Peritonealkarzinose.

Decision Support Document 74

König, Franz; Slattery, Jim; Groves, Trish; Lang, Thomas; Benjamini, Yoav; Day, Simon; Bauer, Peter; Posh, Martin (2014); Sharing clinical trial data on patient level. Opportunities and challenges.

Biometrical Journal; 1-19; Weinheim; ISSN: Online: 1521-4036

Munkhambwa, Emanuel; Baumgärtel, Christoph; Probst, Josef; Krammer, Heinz (2014); Lieferengpässe ja, aber keine Versorgungsengpässe.

Apotheker Krone; (83); 16/JUN/2014

Österreicher, Z.; Zeitlinger, M.; Burgmann, H.; Moser, T.; Lehner, H.; Baumgärtel, Christoph (2014); How similar are generic antimicrobials really? Retrospective Analysis of PK Parameters of Generic and Originator Antibacterials, Antifungals and Antivirals; Presentation Number. A-1324; 08/SEP/2014; Washington, DC, Exhibit Hall B; ICAAC: 153-Clinical Pharmacology and Therapeutic Drug Monitoring of Vancomycin and Newer Lipoglycopeptides/Lipopeptides

Pullirsch, Dieter; Bellemare, J.; Hackl, Andreas; Trottier, Y.L.; Mayrhofer, Andreas; Schindl, Heidemarie; Taillon, C.; Gartner, Christian; Hottowy, B.; Beck, Gerhard; Gagnon, J. (2014); Microbiological contamination in counterfeit and unapproved drugs.

BMC Pharmacol Toxicol.; 15 (1) : 34; 26/JUN/2014

Sewell, Fiona; Chapman, Kathryn; Baldrick, Paul; Brewster, David; Broadmeadow, Alan; Brown, Paul; Burns-Naas, Leigh Ann; Clarke, Janet; Constan, Alex; Couch, Jessica; Czupalla, Oliver; Danks, Andy; de George, Joseph; de Haan, Lolke. Hettinger, Klaudia; Hill, Marilyn; Festag, Matthias; Jacobs, Abby; Jacobson-Kram, David; Kopytek, Stephan; Lorenz, Helga; Gry Moesgaard, Sopia; Moore, Emma; Pasanen, Markku; Perry, Rick; Ragan, Ian; Robinson, Sally; Schmitt, Petra M.; Short, Brian; Silva Lima, Beatriz; Smith, Diane; Sparrow, Sue; van Bekkum, Yvette; Jones, David (2014).

Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.

Regulatory Toxicology and Pharmacology; 70 (1) : 413-429; OKT/2014

Wernsperger, Johanna; Baumgärtel, Christoph (2014); Modifizierte Rahmenbedingungen für die Antibiotika-Entwicklung im Überblick.

Pharm. Ind; 76 (3) : 369-372; Aulendorf, Germany. 10.3389/fphar.2014.00109

2013

Malmström RE, Godman BB, Diogene E, Baumgärtel C, Bennie M et al., Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. Front Pharmacol. 2013 May 14;4:39.

Baumgärtel C, Austria increases dialogue in order to involve physicians more with biosimilars.

Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(1):8.

Godman B, Finlayson AE, Cheema PK, Zebedin-Brandl E, Gutiérrez-Ibarluzea I, Jones J, Malmström RE, Asola E, Baumgärtel C, Bennie M, et al., Personalizing health care: feasibility and future implications.

BMC Med. 2013 Aug 13;11:179. doi: 10.1186/1741-7015-11-179.

Lackner F, Beck G, Eichmeir S, Gemeiner M, Hummel K, Pullirsch D, Razzazi-Fazeli E, Seifner A, Miller I. Contamination of therapeutic human immunoglobulin preparations with apolipoprotein H (-glycoprotein I).

Electrophoresis. 2014 Feb;35(4):515-21. doi: 10.1002/elps.201300319. Epub 2013 Nov 24.

Seifner A, Beck G, Bayer P, Eichmeir S, Lackner F, Rögelsperger O, Weber K, Wollein G. Assessment of immunoglobulin concentrates on thrombogenic activity by thrombin generation assay, prekallikrein activator assay, and size-exclusion chromatography.

Transfusion. 2014 Feb;54(2):376-83. doi: 10.1111/trf.12280. Epub 2013 Jun 17.