BfArM - Federal Institute for Drugs and Medical Devices

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Publications 2009 - 2011

Abernethy DR, DeStefano AJ, Cecil TL, Zaidi K, Williams RL, Lewen N, Shelbourn TL, Barton C, Callis CM, Dentali SJ, Fan AM, Frötschl R, Kazeminy A, Ko R, Turk GC, Wiens R, Blosser R, De M, Fowler BA, Kauffman JF, Merrill JC

Metal Impurities in Food and Drugs. Pharmaceutical Research 27 (5), 2010, 750-755.

Adler S, Bicker G, Bigalke H, Bishop C, Blümel J, Dressler D, Fitzgerald J, Gessler F, Heuschen H, Kegel B, Luch A, Milne C, Pickett A, Ratsch H, Ruhdel I, Sesardic D, Stephens M, Stiens G, Thornton PD, Thürmer R, Vey M, Spielmann H, Grune B, Liebsch M

The Current Scientific and Legal Status of Alternative Methods to the LD50 Test for Botulinum Neurotoxin Potency Testing. ATLA 38, 2010, 315-330.

Aly AF, Menges K, Haas CH, Zimmermann L, Kaltschmidt J, Criegee-Rieck M

Prerequisites for electronic systems evaluating safe and effective drug therapy. A contribution to the Action Plan of the Federal Health Ministry. Bundesgesundheitsblatt 54 (11), 2011, 1170-1178.

Bouchara JP, Horré R, Hoog SD

Pseudallescheria and Scedosporium: Emerging Opportunists. Medical Mycology 47 (4), 2009, 341-342.

Bousquet PJ, Demoly P, Romano A, Aberer W, Bircher A, Blanca M, Brockow K, Pichler W, Torres MJ, Terreehorst I, Arnoux B, Atanaskovic-Markovic M, Barbaud A, Bijl A, Bonadonna P, Burney PG, Caimmi S, Canonica GW, Cernadas J, Dahlen B, Daures JP, Fernandez J, Gomes E, Gueant JL, Kowalski ML, Kvedariene V, Mertes PM, Martins P, Nizankowska-Mogilnicka E, Papadopoulos N, Ponvert C, Pirmohamed M, Ring J, Salapatas M, Sanz ML, Szczeklik A, Van Ganse E, De Weck AL, Zuberbier T, Merk HF, Sachs B, Sidoroff A

Pharmacovigilance of drug allergy and hypersensitivity using the ENDA-DAHD database and the GALEN platform. The Galenda projekt. Allergy 64 (2), 2009, 194-203.

Broich K

Committee for Medicinal Products for Human Use (CHMP) assessment on efficacy of antidepressants. European Neuropsychopharmacology 19, 2009, 305-308.

Broich K, Schlosser G, DelSignore S

Dementia from a regulatory perspective - challenges, opportunities, requirements. Nistico G, DelSignore S, Salmonson T (Eds): Clinical Trials in Brain Diseases in Elderly People. Exorma Roma, 2010, 22-40.

Broich K, Weiergräber M, Hampel H

Biomarkers in clinical trials for neurodegenerative diseases: Regulatory perspectives and requirements. Progress in Neurobiology 95, 2011, 498-500.

Brosteanu O, Houben P, Ihrig K, Ohmann C, Paulus U, Pfistner B, Schwarz G, Strenge-Hesse A, Zettelmeyer U

Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials. Clinical Trials 2009, 1-12.

Colgan ST, Mohan G, Vudathala G, Kasper P, McMahon M

Global regulatory challenges for controlling genotoxic impurities. Part I: Summary of presentations. Regulatory Rapporteur 7 (5), 2010, 23-27.

Colgan ST, Mohan G, Vudathala G, Kasper P, McMahon M

Global regulatory challenges for controlling genotoxic impurities. Part II: Panel discussions and Q&As. Regulatory Rapporteur 7 (6), 2010, 21-23.

Coyle K, Rother KI, Weise M, Ahmed A, Miller FW, Rider LG

Metabolic Abnormalities and Cardiovascular Risk Factors in Children with Myositis. Journal of Pediatrics 155 (6), 2009, 882-887.

Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, Webb CP, Baer W, Senagore A, Schipper MJ, Vonderscher J, Sultana S, Gerhold DL, Phillips JA, Maurer G, Carl K, Laurie D, Harpur E, Sonee M, Ennulat D, Holder D, Andrews-Cleavenger D, Gu Y-Z, Thompson KL, Goering PL, Vidal J-M, Abadie E, Maciulaitis R, Jacobson-Kram D, Defelice AF, Hausner EA, Blank M, Thompson A, Harlow P, Throckmorton D, Xiao S, Xu N, Taylor W, Vamvakas S, Flamion B, Silva Lima B, Kasper P, Pasanen M, Prasad K, Troth S, Bounous D, Robinson-Gravatt D, Betton G, Davis MA, Akunda J, McDuffie JE, Suter L, Obert L, Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, Collins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nature Biotechnology 28, 2010, 455-462.

Ehrt U, Broich K, Larsen JP, Ballard C, Aarsland D

Use of drugs with anticholinergic effect and impact on cognition in Parkinson's disease: a cohort study. Journal of Neurology, Neurosurgery, and Psychiatry 81, 2010, 160-165.

Enzmann H, Weise Martina

Current european regulatory perspectives on insulin analogues. Diabetology & Metabolic Syndrome 2011, 3: 14.

Freudenberger T, Dai G, Mayer P, Heim HK, Schrör K, Fischer JW

Estradiol suppresses hyaluronic acid synthase expression in human vascular smooth muscle cells. Archives of Pharmacology 2009, 379 (Suppl 1): 1-100.

Freudenberger T, Oppermann M, Marzoll A, Heim HK, Mayer P, Kojda G, Weber AA, Schrör K, Fischer JW

Differential effects of medroxyprogesterone acetate on thrombosis and atherosclerosis in mice. British Journal of Pharmacology 158 (8), 2009, 1951-1960.

Freudenberger T, Oppermann M, Heim HK, Mayer P, Kojda G, Schrör K, Fischer JW

Anti-atherogenic but pro-thrombotic effects of medroxyprogesterone acetate in ApoE-/- mice. Clinical Research in Cardiology 2009, 98 (Suppl 1): P1323.

Freudenberger T, Dai G, Mayer P, Heim HK, Fischer JW

Estradiol-mediated inhibition of hyaluronic acid synthase expression and proliferation is restored after lentiviral overexpression of hyaluronic acid synthases 1 and 2 in vascular smooth muscle cells. Clinical Research in Cardiology 2010, 99 (Suppl 1): P690.

Freudenberger T, Oppermann M, Heim HK, Mayer P, Kojda G, Schrör K, Fischer JW

Proatherogenic effects of estradiol in a model of accelerated atherosclerosis in ovariectomized ApoE-deficient mice. Basic Research in Cardiology 105 (4), 2010, 479-486.

Freudenberger T, Dai G, Mayer P, Heim HK, Fischer JW

Lentiviral overexpresion of hyaluronic acid synthases 1 and 2 restores estradiol-mediated inhibition of PDGF-induced proliferation in human vascular smooth muscle cells. Archives of Pharmacology 2010, 381 (Suppl 1): 49.

Freudenberger T, Röck K, Dai G, Dorn S, Mayer P, Heim HK, Fischer JW

Estradiol inhibits hyaluronic acid synthase 1 expression in human vascular smooth muscle cells. Basic Research in Cardiology 106, 2011, 1099-1109.

Freudenberger T, Röck K, Dai G, Mayer P, Heim HK, Schrör K, Fischer JW

Estradiol-mediated ERα-dependent inhibition of HAS1-mRNA-expression is causally involved in inhibition of proliferation in vascular smooth muscle cells. Archives of Pharmacolgy 2011, 383 (Suppl 1): 36.

Friemel A, Zünkler BJ

Interactions at Human ether-à-go-go-Related Gene Channels. Toxicological Sciences 114 (2), 2010, 346-355.

Ghaly H, Kriete Ch, Seher S, Pflöger A, Holzgrabe U, Zünkler BJ, Rustenbeck I

The insulinotropic effect of fluoroquinolones. Biochemical Pharmacology 77, 2009, 1040-1052.

Grüger T, Reiners AL, Schnitzler N, Brandenburg K, Zündorf J

Garenoxacin-induced increase of CD11b expression on human polymorphonuclear neutrophils does not affect phagocytosis and killing of Staphylococcus aureus. Journal of Infection and Chemotherapy 2010, published online 13. August 2010, DOI 10.1007/s1056-010-0099-8.

Haas B, Celner J, Enzmann H, Pfeifer A

Glitazone-like action of glimepiride and glibenclamide in primary human adipocytes. Diabetes, Obesity and Metabolism 2011 (April 7), doi: 10.1111/j.1463-1326.2011.01409.x.

Haas B, Mayer P, Jennissen K, Scholz D, Diaz MB, Bloch W, Herzig S, Fässler R, Pfeifer A

Protein Kinase G Controls Brown Fat Cell Differentiation and Mitochondrial Biogenesis. Science Signaling 2009, Volume 2, Issue 99 ra78, published online 01.12.2009 doi 10.1126/scisignal.2000511.

Halbauer J, Siekmeier R, Funk M

Safety of high risk in vitro diagnostic medical devices. International and national measures. Bundesgesundheitsblatt 52 (6), 2009, 610-619.

Hampel H, Broich K

Enrichment of MCI and early Alzheimer's disease treatment trials using neurochemical and imaging candidate biomarkers. Journal of Nutrition Health and Aging 13, 2009, 373-375.

Hampel H, Broich K, Hoessler Y, Pantel J

Biological markers for early detection and pharmacological treatment of Alzheimer's disease. Dialogues in Clinical Neuroscience 11, 2009, 141-157.

Hampel H, DelSignore S, Papaluca-Amati M, Broich K

Neurochemical and neuroimaging biomarkers of Alzheimer's Disease. Nistico G, DelSignore S, Salmonson T (Eds): Clinical Trials in Brain Diseases in Elderly People. Exorma Roma 2010, 111-132.

Hampel H, Frank R, Broich K, Teipel SJ, Katz RG, Hardy J, Herholz K, Bokde AL, Jessen F, Hoessler YC, Sanhai WR, Zetterberg H, Woodcock J, Blennow K

Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives. Nature Reviews Drug Discovery 9, 2010, 560-574.

Heim HK

Similar biological medicinal products currently licensed in the European Union - Overview of non-clinical study programs. Biologicals 39, 2011, 284-288.

Heinz BC

Arthroplasty registries and their contribution to the safety of patient care in joint replacement. Bundesgesundheitsblatt 52 (6), 2009, 589-593.

Hines RN, Sargent D, Autrup H, Birnbaum LS, Brent RL, Doerrer NG, Cohen Hubal EA, Juberg DR, Laurent C, Luebke R, Olejniczak K, Portier CJ, Slikker W.

Approaches for Assessing Risks to Sensitive Populations: Lessons Learned from Evaluating Risks in the Pediatric Population. Toxicological Sciences 113 (1), 2010, 4-26.

Hinze AV, Harst A, Mayer P, von Kügelgen I

Effects of adenosine on proliferation and gene expression in human coronary artery vascular smooth muscle cells. Purinergic Signalling 2010, 6: 87.

Hinze AV, Harst A, Mayer P, von Kügelgen I

Early gene induction of the nuclear factor NR4A1 in primary human coronary smooth muscle cells by extracellular nucleotides. Archives of Pharmacology 2010, 381 (Suppl 1): 18.

Horré R, Marklein G

Isolation and clinical significance of Pseudallescheria and Scedosporium species. Medical Mycology 47 (4), 2009, 415-421.

Horré R, Marklein G, Siekmeier R, Nidermajer S, Reiffert

Selective Isolation of Pseudallescheria ans Scedosporium Species from Respiratory Tract Specimens of Cystic Fibrosis Patients. Respiration 77 (3), 2009, 320-324.

Höschele D, Wiertz M

Mitochondrial effects of chloramphenicol and linezolid in HepG2 cells. Toxicology Letters 2009, Volume 189S: 262.

Hütten M, Lassay L, Sachs B, Deutz P, Mertens R, Baron JM, Merk HF, Ott H

Successful topical treatment of sorafenib-induced handfoot skin reaction in a child with hepatocellular carcinoma. Pediatric Dermatology, 26 (3), 2009, 349-350.

Kaber G, Kaiser B, Baumgärtel-Allekotte D, Noßmann S, Heim HK, Weber AA, Nagy N, Fischer JW, Schrör K

Antagonism of the antithrombotic and antiatherosclerotic actions of aspirin by rofecoxib in the cholesterol-fed rabbit. British Journal of Pharmacology 164 (2b), 2011, 561-569.

Kasper P

Adherence to the 3R principles in the ICH process. Alternatives to Animal Experimentation ALTEX 26 (Special Issue), 2009: 154.

Kasper P

Genotoxicity testing in vivo: Strategies to reduce the number of animals in mandatory regulatory studies. Alternatives to Animal Experimentation ALTEX 26 (Special Issue), 2009: 249.

Kasper P

Genotoxicity. Cartwright T, Matthews B (Eds): International Pharmaceutical Product Registration (2nd Edition). Informa Healthcare USA, 2009, 402-418.

Kasper P

Genotoxicity testing of pharmaceuticals: An update on changing regulatory guidances. Toxicology Letters 196S, 2010, S13-S14.

Knapp K, Graikou K, Chinou I, Knöss W

Modern approaches to characterise the quality of Propolis. Planta Medica 2010, Volume 76, P015: 1196.

Knapp K, Kehraus S, Orland A, König G, Knöss W

Identification of herbal substances in finished herbal medicinal products. Planta Medica 2010, Volume 76, P016: 1197.

Krämer E, Schütz E, Frötschl R

Site specific phosphorylation of p53 may depend on phosphorylation of p38 defferently activated by substances with different genotoxic mode of action. Mutagenesis 2011, 26 (5) P89: 717-718.

Lackner M, Klaassen CH, Meis JF, Gerrits van den Ende AHG, de Hoog GS

Molecular identification tools for sibling species of Scedosporium and Pseudallescheria. Medical Mycology 2011, 1-12, doi: 10.3109/13693786.2011.618939.

Lehmann B, Mentzer D, Fischer T, Mallinckrodt-Pape K

Clinical trials in children - Between the expectations of scientific requirements, the assurance of proven treatment and ethical demands. Bundesgesundheitsblatt 52 (4), 2009, 410-416.

von Mallek D, Wetzel D, Schrappe M, Hölscher U

Patient safety and innovation. Bundesgesundheitsblatt 52 (6), 2009, 575-576.

von Mallek D, Biersack HJ, Mull R, Wilhelm K, Heinz B, Mellert F

Medical technology and medical education. Bundesgesundheitsblatt 53 (8), 2010, 846-852.

Martin M, Ott H, Merk HF and Sachs B

Analysis of cytokine secretion from lymphocytes of patients with hypersensitivity reactions to contaminated heparins. British Journal of Dermatology 164, 2011, 68-75.

Martin M, Wurpts G, Ott H, Baron JM, Erdmann S, Merk HF, Sachs B

In vitro detection and characterization of drug hypersensitivity using flow cytometry. Allergy 65, 2010, 32-39.

Mayer P, Hinze AV, Harst A, von Kügelgen I

A2B receptors mediate the induction of early genes and inhibition of arterial smooth muscle cell proliferation via Epac. Cardiovascular Research 90, 2011, 148-156.

Mayer P, Haas B, Celner J, Enzmann H, Pfeifer A

Glitazone-like action of glimepiride and glibenclamide in primary human adipocytes. Diabetes, Obesity and Metabolism 2011 (April 7), doi: 10.1111/j.1463-1326.2011.01409.x.

Mayer P, Mering S, Warnken M, Reitzenstein U, Racké K

Interaction of TGF-ß and insulin/IGF-I stimulation in human bronchial fibroblasts and epithelial cells. Archives of Pharmacology 2009, 379 (Suppl 1): 36.

Mayer P, Warnken M, Mehring B, Reitzenstein U, Racké K, Enzmann H

Growth-factor-like effects of low insulin concentrations in H292 human bronchial carcinoma comparison with human normal bronchial epithelial cells. American Journal of Respiratory and Critical Care Medicine 2010, 181: A2071.

Mayer P, Reitzenstein U, Warnken M, Mering S, Enzmann H, Racké K

Insulin actions in H292 bronchial carcinoma cells as compared to normal human bronchial epithelial cells. Archives of Pharmacology 2010, 381 (Suppl 1): 56.

McCabe C, Bergmann L, Bosanquet N, Ellis KM, Enzmann H, von Euler M, Jönsson B, Kallen KJ, Newling D, Nüssler V, Paschen B, de Wilde R, Wilking N, Teale C, Zwierzina H

Market and Patient Access to New Oncology Products in Europe: A Current, Multidisciplinary Perspective. Annals of Oncology 20 (3), 2009, 403-412.

Mellert, von Mallek D

Medical devices and patient safety from the clinicians' view. Bundesgesundheitsblatt 52 (6), 2009, 584-588.

Meyer RE, Salzman C, Youngstrom EA, Clayton PJ, Goodwin FK, Mann JJ, Alphs LD, Broich K, Goodman WK, Greden JF, Meltzer HY, Normand SL, Posner K, Shaffer D, Oquendo MA, Stanley B, Trivedi MH, Turecki G, Beasley CM jr., Beautrais AL, Bridge JA, Brown GK, Revicki DA, Ryan ND, Sheehan DV

Suicidality and risk of suicide-definition, drug safety concerns, and a necessary target for drug development: a brief report. Journal of Clinical Psychiatry 2010.

Moller HJ, Broich K

Principle standards and problems regarding proof of efficacy in clinical psychopharmacology. European Archives of Psychiatry and Clinical Neuroscience 260, 2010, 3-16.

Olejniczak K, Bass R

Nonclinical Testing Strategy. Cartwright T, Matthews B (Eds): International Pharmaceutical Product Registration (2nd Edition). Informa Healthcare New York, London, 2009, 300-322.

Pfuhler S, Kirkland D, Kasper P, Hayashi M, Vanparys P, Carmichael P, Dertinger S, Eastmond D, Elhajouji A, Krul C, Rothfuss A, Schoening G, Smith A, Speit G, Thomas C, van Benthem J, Corvi R

Reduction of use of animals in regulatory genotoxicity testing: Identification and implementation opportunities - Report from an ECVAM Workshop. Mutation Research/Genetic Toxicology and Environmental Mutagenesis 680, 2009, 31-42.

Pfuhler S, Fellows M, van Benthem J, Corvi R, Curren R, Dearfield K, Fowler P, Frötschl R, Elhajouji A, Le Hégarat L, Kasamatsu T, Kojima H, Quédraogo G, Scott A, Speit G

In vitro genotoxicity test approaches with better predictivity: summary of an IWGT workshop. Mutation Research 723 (2), 2011, 101-107.

Reitzenstein U, Fuhrmann R, Mayer P, Enzmann H, Racké K, Warnken M

Characterization of proliferative effects of insulin in human lung fibroblasts. Archives of Pharmacology 2009, 379 (Suppl 1): 10 and American Journal of Respiratory and Critical Care Medicine 2009, 179: A3477.

Rodriguez-Tudela JL, Berenguer J, Guarro J, Serda Kantarcioglu A, Horré R, de Hoog GS, Cuenca-Estrella M

Epidemiology and outcome of Scedosporium prolificans infection, a review of 162 cases. Medical Mycology 47 (4), 2009, 415-421.

Rölleke T

Relevancy and binding character of standards for the safety of medical devices. Bundesgesundheitsblatt 52 (6), 2009, 605-609.

Schriever J, Schwarz G, Steffen C, Krafft H

The authorization of clinical trials by the federal authorities. Bundesgesundheitsblatt 52 (4), 2009, 377-386.

Shukla A, Enzmann H, Mayer D

Proliferative effect of Apidra (insulin glulisine), a rapid-acting insulin analogue on mammary epithelial cells. Archives of Physiology and Biochemistry 115 (3), 2009, 119-126.

Shukla A, Grisouard J, Ehemann V, Hermani A, Enzmann H, Mayer D

Analysis of signaling pathways related to cell proliferation stimulated by insulin analogs in human mammary epithelial cell lines. Endocrine-Related Cancer 16, 2009, 429-441, published online 19.01.2009, http://dx.doi.org/10.1677/ERC-08-0240.

Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu Y-Z, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Silva Lima B, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal J-M, Vonderscher J, Walker E, Webb C, Yu Y

Towards consensus practices to qualify safety biomarkers for use in early drug development. Nature Biotechnology 28, 2010, 446-454.

Sudhop T

Compassionate use of non-approved medicinal products. Legal basis and guidelines. Bundesgesundheitsblatt 52 (4), 2009, 439-443.

Sudhop T, Enzmann H, Klar R

Clinical research. Effects of European legislation and current developments. Bundesgesundheitsblatt 52 (4), 2009, 375-376.

Tintelnot K, Just-Nübling G, Horré R, Graf B, Sobottka I, Seibold M, Haas A, Kaben U, de Hoog GS

A review of German Scedosporium prolificans cases from 1993 to 2007. Medical Mycology 47 (4), 2009, 351-358.

Warnken M, Reitzenstein U, Fuhrmann R, Mayer P, Enzmann H, Racké K

Characterization of proliferative effects of insulin and insulin-like growth factor in human airway epithelial cells. American Journal of Respiratory and Critical Care Medicine 2009, 179: A4982.

Warnken M, Reitzenstein U, Fuhrmann R, Mayer P, Enzmann H, Racké K

Characterization of proliferative effects of insulin and insulin-like growth factor in human airway epithelial cells. Archives of Pharmacology 2009, 379 (Suppl 1): 10.

Warnken M, Reitzenstein U, Sommer A, Fuhrmann M, Mayer P, Enzmann H, Juergens UR, Racké K

Characterization of proliferative effects of insulin, inulin analogues and insulin-like growth factor-1 (IGF-1) in human lung fibroblasts. Archives of Pharmacology 2010, 382: 511-524.

Weise M, Schneider C

Biosimilars in the EU: the interplay of regulators, treating physicians and pharmacists. Hospital Pharmacy Europe 43, 2009, 31-33.

Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, Heim HK, Heinonen E, Ho K, Thorpe R, Vleminckx C, Wadhwa M, Schneider CK

Biosimilars - why terminology matters. Nature Biotechnology 2011 (8), Volume 29, 690-693.

Wetzel D, von Mallek D

Information on the policies of the Medical Devices Safety Act. Bundesgesundheitsblatt 52 (6), 2009, 577-578.

Williams GM, Brunnemann KD, Iatropoulos MJ, Smart DJ, Enzmann HG

Production of liver preneoplasia and gallbladder agenesis in turkey fetuses administered diethylnitrosamine. Archives of Toxicology 2011 (6), Volume 85, 681-687 .

Wollanka H, Weidenmaier W, Giersig C

NSF after Gadovist exposure: a case report and hypothesis of NSF development. Nephrology Dialysis Transplantation 24, 2009, 3882-3884.

Zünkler BJ, Friemel A

Allosteric interactions between terfenadine and chlorobutanol on hERG channels. Toxicology Letters 2009, 189S: 257.

Zünkler BJ, Wos-Maganga M

Comparison of the effects of methadone and heroin on human ether-à-go-go-related gene channels. Cardiovascular Toxicology 10, 2010, 161-165.