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Publikationen 2007 bis 2008

Bachmann P

Europäische Verfahren der gegenseitigen Anerkennung im Bereich der Humanarzneimittel. Dezentrales Verfahren und gegenseitige Anerkennung. Bundesgesundheitsblatt 51 (7), 2008, 722-730.

Broich K

Outcome measures in clinical trials on medicinal products for the treatment of dementia: a European regulatory perspective. International Psychogeriatrics 19, 2007, 509-524.

Broich K, Möller HJ

Pharmacogenetics, Pharmacogenomics and Personalized Psychiatry: Are we there yet? European Archives of Psychiatry and Clinical Neuroscience 258 (Suppl 1), 2008, 1-2.

Burlinson B, Tice R, Speit G, Agurell E, Brendler-Schwaab S, Collins A, Escobar P, Honma M, Kumaravel T, Nakajima M, Sasaki YF, Thybaud V, Uno Y, Vasquez M, Hartmann A

Results of the in vivo Comet Assay Workgroup. Mutation Research 627 (Issue 1), 2007, 31-35.

Claaßen S, Ludwig J, Zünkler BJ

Electrophysiological and fluorescence microscopy studies with HERG channel/EGFP fusion proteins. Archives of Pharmacology 2007, Volume 375: 46.

Claaßen S, Schwarzer S, Ludwig J, Zünkler BJ

Electrophysiological and Fluorescence Microscopy Studies with HERG channel/EGFP Fusion Proteins. Journal of Membrane Biology 222, 2008, 31-41.

Daniel C, Kersten T, Kehraus S, König G, Knöss W

Identifizierung und Charakterisierung von Arzneipflanzen mit "Metabolic Fingerprinting". Zeitschrift für Phytotherapie 29, 2008, 270-274.

Enzmann H, Schneider C

Die Rolle des Ausschusses für Humanarzneimittel (CHMP) bei der europäischen zentralen Zulassung. Bundesgesundheitsblatt 51 (7), 2008, 731-739.

Fielden MR, Nie A, McMillian M, Elangbam CS, Trela BA, Yang Y, Dunn II RT, Dragan Y, Fransson-Stehen R, Bogdanffy M, Adams SP, Foster WR, Chen SJ, Rossi P, Kasper P , Jacobson-Kram D, Tatsuoka KS, Wier PJ, Gollub J, Halbert DN, Roter A, Young JK, Sina JF, Marlowe J, Martus HJ, Aubrecht J, Olaharski AJ, Roome N, Nioi P, Pardo I, Snyder R, Perry R, Lord P , Matthes W, Car BD

Interlaboratory evaluation of genomic signatures for predicting carcinogenicity in the rat.Toxicology Sciences 103, 2008, 28-34.

Fischer T

Das Data Monitoring Committee. Die dritte Säule in der methodischen Durchführung von klinischen Prüfungen. Bundesgesundheitsblatt 51 (7), 2008, 793-796.

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

Der Verlust von endogenem Estradiol nach bilateraler Ovariektomie zeigt in ApoE-Defizienten Mäusen anti-Atherogene Effekte und verbessert die Endothelfunktion. Deutsche Medizinische Wochenschrift 132, 2007, Suppl 1.

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

Effects of estradiol and medroxyprogesterone acetate on atherosclerosis and thrombosis in ApoE mice. Archives of Pharmacology 2008, 377 (Suppl 1): 1-98.

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

Effects of estrogenes and gestagens on atherosclerosis and thrombosis after surgically induced menopause in ApoE mice. Journal of Hypertension 2008, Volume 26 (Suppl 1).


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

Estradiol and medroxyprogesterone acetate: differential roles in atherosclerosis, endothelial function and thrombosis after surgically induced menopause in ApoE mice. European Heart Journal 2008, 29 (Suppl): 864-865.


Frötschl R, Kasper P

Microarrays in drug development: regulatory perspektive. Parnham (Ed): Microarrays in Inflammation, Progress in Inflammation Research Series, Birkhäuser Verlag, 2008, 199-209.

Garcia-Moreno I, Wiertz M, Höschele D

Development of an in ovo model for investigation of mitchonondrial toxicity of nucleoside reverse transcriptase inhibitors. Archives of Pharmacology 2007, Volume 375 (Suppl 1), No 487: 96.

Garcia-Moreno I, Wiertz M, Höschele D

Investigation of mitochondrial toxicity of nucleoside reverse transcriptase inhibitors in a newly developed in ovo model. Toxicology Letters 2007, Volume 172: 78.

Garcia-Moreno I, Wiertz M, Höschele D

Influence of mitochondrial toxic drugs on mitochondrial gene expression in ovo. Archives of Pharmacology 2008, Volume 377 (Suppl 1), No 372: 75.

Ghaly H, Kriete C, Sahin S, Pflöger A, Holzgrabe U, Zünkler BJ, Rustenbeck I

The insulinotropic effect of fluoroquinolones. Biochemical Pharmacology 2008 (in press)

Giersig C

Gestagene und Brustkrebs. Die fehlenden Puzzleteile. Bundesgesundheitsblatt 51 (7), 2008, 782-786.

Giersig C

Nephrogene systemische Fibrose als unerwünschte Arzneimittelwirkung gadoliniumhaltiger Kontrastmittel für die Magnetresonanztomographie. Der Radiologe 2007, 1-6.

Giersig C

Nephrogenic systemic fibrosis as an adverse drug reaction of gadolinium-based contrast media for magnetic resonance imaging. Radiologie 47, 2007, 794-799.

van Gool AJ, Spindler P, Harpur E, Bounous D, Olejniczak K, van de Klundert FA, Haenen B

Biomarkers in the drug development process: Report from workshop discussions. Regulatory Toxikology and Pharmacology 52, 2008, 75-76.

Green-Golan L, Yates C, Drinkard B, VanRyzin C , Eisenhofer G, Weise M , Merke DP

Patients with Classic Congenital Adrenal Hyperplasia Have Decreased Epinephrine Reserve and Defective Glycemic Control During Prolonged Moderate-Intensity Exercise. Journal of Clinical Endocrinology and Metabolism 92, 2007, 3019-3024 .

Grote-Wessels S, Buchwalow I, Fabritz L, Zimmermann N, Schmitz W, Müller FU, Boknik P

Functional Studies in mice overexpressing A2A Adenosine Receptors in the Heart. Archives of Pharmacolgy 2007, Volume 375, Suppl 1: 59.

Grüger T, Schnitzler N, Nidermajer S, Brandenburg K, Zündorf J

Influence of linezolid on phagocytosis and killing og Gramnegative bacteria by polymorphonuclear neutrophils. Clinical Microbiology and Infection 2008, 14 (7): P762.

Grüger T, Schnitzler N, Horré R, Brandenburg K, Nidermajer S, Zündorf J

Influence of Quinolones on CD11b-Expression of Human Polymorphonuclear Neutrophils (PMN) and Subsequent Phagocytosis and Killing of Methicillin resistant Staphylococcus aureus (MRSA). Intensive Care Medicine 2008, 34, Suppl 1: 28 (0095).

Grüger T, Schnitzler N, Horré R, Brandenburg K, Nidermajer S, Zündorf J

Phagocytosis and killing of methicillin-resistant Staphylococcus aureus (MRSA) by human polymorphonuclear neutrophils in the presence of fluoroquinolones. International Journal of Medical Microbiology 2008, 298, Suppl 2: 1-118 (AIP08).

Grüger T, Mörler C, Schnitzler N, Brandenburg K, Nidermajer S, Horré R, Zündorf J

Influence of fluoroquinolones on phagocytosis and killing of Candida albicans by human polymorphonuclear neutrophils. Medical Mycology 46 (7), 2008 675-684.

Hagemann U, Paeschke N

Spontaneous Reporting in Germany. Pharmacovigilance, 2nd edition, 2007, Chapter 18.

Haverkamp JB, Lipke U, Zapf T, Galensa R, Lipperheide C

Interaktion zwischen Arzneimittel und Primärverpackung. Untersuchung von halbfesten Darreichungsformen und Aluminiumtuben mit epoxidphenolhaltiger Innenbeschichtung. Apotheken-Magazin 25, 2007, 8-14.

Haverkamp JB, Lipke U, Zapf T, Galensa R, Lipperheide C

Contamination of semi-solid dosage forms by leachables from aluminium tubes. European Journal of Pharmaceutics and Biopharmaceutics 70, 2008, 921-928.

Heinz B, Ladhoff U, Kahl C, Rzany B, von Mallek D

Vorkommnisse zu injizierbaren Füllmaterialien. Auswertung des Medizinprodukte-Beobachtungs- und Meldesystems in Deutschland. Bundesgesundheitsblatt 51 (7), 2008, 787-792.

Horn M

Neuregelung der Verlängerung von Zulassungen und Einführung der Sunset-Clause. Erfahrungen des BfArM mit der neuen Gesetzgebung. Bundesgesundheitsblatt 51 (7), 2008, 740-747.

Horré R

Cerebral Infections due to Pseudallescheria boydii after near-drowning, a special entity. Mycoses 2007, 50 (5): 379, P39.

Horré R

Eumyzetome und andere Erkrankungen durch Pseudallescheria/Scedosporium Spezies. Hofmann F (Hrsg.): Handbuch der Infektionskrankheiten. 28. Ergänzungslieferung. Ecomed-Verlag. 2008, Kapitel VIII-3.4.3: 1-11.

Horré R, Choi SM, de Hoog GS,

Species of Ochroconis: taxonomy, medical significance and methods for isolation and identification. Mycoses 2007, 50 (5): 379, P38.

Horré R, Lackner M, de Hoog GS, Bouchara JP

Update on Scedosporium/Pseudallescheria Infections. Clinical Microbiology and Infections 2008, 14 (7): P2193.

Horré R, Siekmeier R, de Hoog GS, Tintelnot K

Pseudallescheriose/Scedosporiose der Lunge und des Gehirns nach Beinahe-Ertrinken - Review und Re-Identifizierung von Isolaten aus Deutschland. Atemwegs- und Lungenkrankheiten; Zeitschrift für Diagnostik und Therapie 34, 2008, 295-300.

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

Isolation von Pilzen des Pseudallescheria/Scedosporium-Komplexes aus dem Respirationstrakt von Patienten mit zystischer Fibrose in Bonn, Atemwegs- und Lungenkrankheiten, Zeitschrift für Diagnostik und Therapie 34, 2008, 301-306.

Horré R, Robert V, de Hoog GS, Becker W, Symoens F, Garcia-Hermoso D, Göttlich E

The Scedosporium/Pseudallescheria Database and Culture Collection.Clinical Microbiology and Infection 2007 (Sonderband): 348, P1266.

Höschele D, Garcia-Moreno I, Wiertz M

Mitochondrial toxicity of combinations of nucleoside reverse transcriptase inhibitors (NRTIs) - Investigation of potential additive or synergistic toxic effects in HepG2 cells. Archives of Pharmacology 2007, Volume 375 (Suppl 1), No 375: 77.

Höschele D, Garcia-Moreno I, Wiertz M

Establishment of a HepG2 cell culture model for detection of drug-induced mitochondrial toxicity. Toxicology Letters 2007, Volume 172: 79.

Höschele D, Wiertz M, Garcia-Moreno I

Different effects of nucleoside reverse transcriptase inhibitors on mitochondrial gene expression. Archives of Pharmacology 2008, Volume 377 (Suppl 1), No 371: 75.

Höschele D, Wiertz M, Garcia-Moreno I

A duplex real-time PCR assay for detection of drug-induced mitochondrial DNA depletion in HepG2 cells. Analytical Biochemistry 379 (2), 2008, 208-210 .

Kasper P

How to manage genotoxic impurities in pharmceuticals: A new CHMP guideline provides instructions. Industrial Pharmacy 14, 2007, 14-16.

Kasper P

How to manage genotoxic impurities in pharmceuticals. PharmacoVigilance Review 3, 2007, 19-21.

Kasper P, Uno Y, Mauthe R, Asano N, Douglas G, Matthewes E, Moore M, Mueller L, Nakajima M, Singer T, Speit G

Follow-up testing of rodent carciongens not positive in the standard genotoxicity testing battery: IWGT workgroup report, Mutation Research - Genetic Toxicology and Environmental Mutagenesis 627, 2007, 106-116.

Kersten T, Daniel C, König G, Knöss W

Das Potenzial PCR-basierter Markermethoden zur Identifizierung von Arzneipflanzen. Zeitschrift für Phytotherapie 29, 2008, 122-128.

Kirchner C, Werner C , Knöss W

Regulatorische Einordnung von Mistelpräparaten. Scheer, Alban, Becker, Holzgrabe, Kemper, Kreis, Matthes, Schilcher (Hrsg): Die Mistel in der Tumortherapie 2: Aktueller Stand der Forschung und klinische Anwendung. KVC Verlag, 2008, 3-13.

Kirkland DJ, Hayashi M, Jacobson-Kram D, Kasper P, MacGregor JT, Müller L, Uno Y

The International Workshops on Genotoxicity Testing (IWGT): History and Achievements. Mutation Research 627, 2007, 1-4.

Kirkland DJ, Kasper P, Müller L, Corvi R, Speit G

Recommended lists of genotoxic and non-genotoxic chemicals for assessment of the performance of new or improved genotoxicity tests: A follow-up to an ECVAM Workshop. Mutation Research - Genetic Toxicology and Environmental Mutagenesis 653, 2008, 99-108.

Kirkland DJ, Pfuhler S, Tweats D, Aardema M, Corvi R, Daroudi F, Elhajouji A, Glatt HR, Hastwell P, Hayashi M, Kasper P, Kirchner S, Lynch A, Marzin D, Maurici D, Meunier JR, Müller L, Nohynek G, Parry J, Parry E, Thybaud V, Tice R, van Benthem J, Vanparys P, White P

How to reduce false positive results with in vitro genotoxicity testing and avoid unnescessary follow-up animal tests: Report of an ECVAM Workshop. Mutation Research - Genetic Toxicology and Environmental Mutagenesis 628, 2007, 31-55.

Knöss W, Stolte F, Reh K

Europäische Gesetzgebung zu besonderen Therapierichtungen. Bundesgesundheitsblatt 51 (7), 2008, 771-778.

Lackner M, Horré R

Culture characteristics of Pseudallescheria/Scedosporium Strains. Mycoses 2008, 51 (5): 402-403 (R67).

Lackner M, Poeder R, Horré R

Aktuelles von der European Confederation of Medical Mycology der International Society for Human and Animal Mycology (ECMM-ISHAM) Pseudallescheria/Scedosporium Working Group. Chemotherapie Journal 2008, 17: 69.

Lackner M, Poeder R, Grüger T, Schnitzler N, Zündorf J, Schween U, Nidermajer S, Brandenburg K, Reiners AL, Horré R

Culture characteristics of strains of the Pseudallescheria/Scedosporium complex. Clinical Microbiology and Infection 2008, (Sonderband): S348, P1266.

Lehmann B

Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations. BioMed Central - Adolescent Psychiatry and Mental Health, online published 08.12.2008, doi: 10.1186/1753-2000-2-37.

Lehmann B

Clinical research in minors and the mentally ill. Thiele, Fegert, Stock (eds): Graue Reihe (No 46) der Europäischen Akademie zur Erforschung von Folgen wissenschaftlich-technischer Entwicklungen, 2008, 77-89.

Lehmann B

Überblick über die Entwicklung der europäischen Rechtsetzung zur Angleichung der Arzneimittelvorschriften. Bundesgesundheitsblatt 51 (7), 2008, 713-721.

Lipperheide C, Haverkamp J, Norwig J

Gut verpackt - Regulatorische Anforderungen an die Primärverpackung von Parenteralia. SterilTechnik 1, 2007, 24-25 .

Lütz J, Enzmann H

European Incentives for Orphan Medicinal Products. Bundesgesundheitsblatt 51 (5), 2008, 500-508.

Madle S, Kasper P, Pabel U, Speit G

Strategies for Evaluation of Genotoxicity. Greim., Snyder (Eds): Toxicology and Risk Assessment: A comprehensive Introduction, Jon Wiley & Sons, 2008.

von Mallek D, Heinz BC, Löffler BG, Mellert F

Vorkommnissmeldungen bei mechanischen Herzklappenprothesen. Auswertung des deutschen Medizinprodukte-Beobachtungs- und Meldesystems im Bundesinistitut für Arzneimittel und Medizinprodukte. Deutsche medizinische Wochenschrift 133, 2008, 2008-2013.

Mayer D, Shukla A, Enzmann H

Proliferative effects of insulin analogues on mammary epithelial cells. Archives of Physiology and Biochemistry 114 (1), 2008, 38-44.

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

Biotherapy Development Association: Market and Patient Access to New Oncology Products in Europe: A Current, Multidisciplinary Perspective. Oxford Journals Annals of Oncology, 2008 (in press).

Menges K

Die Harmonisierung des Zulassungsdossiers: Perspektiven einheitlicher Vorgaben. Arzneimittelprüfrichtlinien und Common Technical Document. Bundesgesundheitsblatt 51 (7), 2008, 748-756.

Mörler C, Grüger T, Brandenburg K, Nidermajer S, Schnitzler N, Horré R, Zündorf J

Influence of newer fluoroquinolones on phagocytosis and killing of Candida albicans by human polymorphonuclear neutrophils. International Journal of Antimicrobial Agents 2007, Volume 29 Suppl 2: 596 und Clinical Microbiology and Infection 2007, Volume 13, Issue s1: 596.

Olejniczak K

Excipients. Journal of Pharmacy and Pharmacology 2007, Suppl 1: A-66.

Olejniczak K, Bode G, Kasper P, von Kreutz E, Kramer PJ

Non-clinical Study Reports. Friese, Jentges, Muazzam (Eds): Guide to Drug Regulatory Affairs, Editio Cantor Verlag, 2007, 685-718.

Olejniczak K, Williams RT, Kühler T, Spindler P

Summary of Workshop on Use of Data Developed During Drug Development for Read Across to Environmental Analyses. Drug Information Journal 41, 2007, 201-202.

Przybilla B, Aberer W, Bircher AJ, Brehler R, Brockow K, Dickel H, Fuchs T, Hertl M, Mockenhaupt M, Pfaar O, Ring J, Sachs B, Vieluf D, Wedi B, Worm M, Zuberbier T, Merk HF

Allergological approach to drug hypersensitivity reactions. Journal Deutsche Dermatologische Gesellschaft 1, 2008.

Radulescu RT, Hufnagel C, Luppa P, Hellebrand H, Kuo WL, Rosner MR, Harbeck N, Giersig C, Meindl A, Schmitt M and Weirich G

Immunohistochemical demonstration of the zinc metalloprotease insulin-degrading enzyme in normal and malignant human breast: Correlation with tissue insulin levels. International Journal of Oncology 30, 2007, 73-80.

Roth S, Langguth P, Spicher K, Enzmann H

Comparative toxicity and cell-tissue distribution study on nanoparticular iron complexes using avian embryos and HepG2-cells. Translational Research 151, 2008, 36-44.

Sachs B, Martin M, Merk HF

Stellenwert des Lymphozyten-Transformations-Tests in der Diagnostik von Arzneimittelallergien. Allergologie 4, 2008.

Sachs B, Fischer-Barth W, Erdmann S, Merk HF, Seebeck J

Anaphylaxis and toxic epidermal necrolysis or Stevens- Johnson syndrome after nonmucosal topical drug application: fact or fiction? Allergy 62, 2007, 877-883.

Sachs B, Martin M, Erdmann S, Grüger T

Nach der Sommerzeit - Photosensitive Reaktionen auf Antibiotika. Der Hautarzt 10, 2007, 904-906.

Seitz R, Enzmann H

Arzneimittelzulassung: Europäische Zusammenarbeit ohne Alternative. Bundesgesundheitsblatt 51 (7), 2008: 703.

Spindler P, Montforts M, Olejniczak K, Koschorreck J, Vidal JM, Johansson AK, Stemplewski H, Virtanen V, Rönnefahrt I, Kristensen S, van der Laan JW

Environmental Risk Assessment in the EU. Drug Information Journal 41, 2007, 149-153.

Steffen C

The dilemma of approving antidotes. Toxicology 233 (1-3), 2007, 13-19 .

Stolte F

Pflanzliche und traditionelle Arzneimittel - erste Erfahrungen mit der Registrierung nach §§ 39a ff. AMG. Pharma Recht 3, 2008, 133-136.

Thybaud V, Aardema M, Casciano D, Dellarco V, Embry MR, Gollapudi BB, Hayashi M, Holsapple MP, Jacobson-Kram D, Kasper P, MacGregor JT, Rees R

Relevance and follow-up of positive results in in vitro genetic toxicity assays: an ILSI-HESI initiative. Mutation Research 633, 2007, 67-79.

Tintelnot K, Just-Nübling G, Sobottka I, Haas A, Horré R

Scedosporium prolificans in Germany: Patients with deep infections or long lasting colonisation from 1993 to 2007 and characterization of the clinical isolates. International Journal of Systematic and Evolutionary Microbiology 2007, 297 (S1): 96-97.

Tintelnot K, Wagner N , Seibold M, de Hoog GS, Horré R

Re-identification of clinical isolates of the Pseudallescheria boydii-complex involved in near-drowning. Mycoses 51, 2008, 11-16.

Ukelis U, Kramer PJ, Olejniczak K

Replacement of In Vivo Toxicity by In Vitro Cytotoxicity Methods: Opportunities, Limits and Regulatory Status. Regulatory Toxikology and Pharmacology 51, 2008, 108-118.

Webb S, Ternes T, Gibert M, Olejniczak K

Indirect Human Exposure to Pharmaceuticals via Drinking Water. Dietrich, Webb, Petry (Hrsg). Hot spot pollutants: Pharmaceutical in the Environment, Elsevier Academic Press, 2007, 79-94.

Weber AA, Heim HK, Schumacher M, Schrör K, Hohlfeld T

Effects of selective cyclooxygenase isoform inhibition on systemic prostacyclin synthesis and on platelet function at rest and after exercise in healthy volunteers. Platelets 18, 2007, 379-385.

Weirich G, Mengele K, Yfanti C, Gkazepis A, Hellmann D, Welk A, Giersig C, Kuo WL, Rosner RM, Tang WJ, Schmitt M

Immunohistochemical evidence for ubiquitous distribution of the metalloendoprotease insulin-degrading enzyme (IDE; insulysin) in human non-malignant tissues and tumor cell lines. Biological Chemistry 389 (11), 2008, 1441-1445.

Weiß C, Schnädelbach D, Manns D

Quality-relevant compounds in homeopathic mother finctures - Isolation and characterisation of 3,5- and 4,5-dicaffeoylquinic acid. Planta Medica 73, 2007: 918.

Williams GM, Iatropoulos MJ, Enzmann H

Principles of Testing for Carcinogenic Action. Hayes, A.W. (Ed): Principles and Methods of Toxicology , 2007, 1265-1316.

Yfanti C, Mengele K, Gkazepis A, Weirich G, Giersig C, Kuo WL, Tang WJ, Rosner RM, Schmitt M

Expression of metalloprotease insulin-degrading enzyme insulysin in normal and malignant human tissues. International Journal of Molecular Medicine 22 (4), 2008, 421-431.

Zündorf J, Schween U, Schnitzler N, Horré R, Brandenburg K, Nidermajer S, Grüger T

Effects of Perfluiocarbons on Phagocytosis and Killing of Staphylococcus aureus by Human Polymorphonuclear Neutrophils. Intensive Care Medicine 2008, 34, Suppl 1: 50 (0183).

Zündorf J, Kremer S, Grüger T

Formation of hydrogen fluoride by gamma and beta sterilisation in medical devices containing perfluoroheptane. Toxicology 243, 2008, 284-293.