Volume 52, No. 1/2014(January)
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Original
Prescribing patterns of duloxetine in France: a prescription assessment study in real-world conditions
Beatrice Augendre-Ferrante, Hernan Picard, David Evans, Hafida Arkoub, Sireesha Pamulapati, Serge Perrot, Paul Valensi and Frederic Rouillon
Price
42.00 $
Page No. 1
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (1-7)
Prescribing patterns of duloxetine in France: a prescription assessment study in real-world conditions
Beatrice Augendre-Ferrante1, Hernan Picard1, David Evans1, Hafida Arkoub1, Sireesha Pamulapati2, Serge Perrot3, Paul Valensi4, and Frederic Rouillon5
1Lilly France, Medical Department, Biomedicines, Neuilly sur Seine Cedex, France, 2Lilly UK, Windlesham, Surrey, United Kingdom, 3Pain Center and Department of Internal Medicine, Hotel Dieu Hospital, Assistance Publique-Hopitaux de Paris, Paris Descartes University, Paris, 4Department of Endocrinology, Diabetology and Nutrition, Jean Verdier Hospital, AP-HP, Paris Nord University, Bondy, and 5Clinique des Maladie Mentales et de l‘Encephale, Sainte Anne Hospital, Paris, France
Duloxetine is a serotonin and norepinephrine reuptake inhibitor approved in the European Union for the treatment of major depressive disorder, generalized anxiety disorder, and diabetic peripheral neuropathic pain in adults. This study aimed to assess the real-world conditions of duloxetine use in France. Between April 2009 and January 2010, 290 dispensing pharmacies, randomly selected from a nationally representative list, included 1,104 patients who presented a duloxetine prescription and consented to the study. Demographic, clinical, and prescription data were extracted from pharmacy records and requested from prescribing physicians. Of the 294 patients with full data available, the mean age (standard deviation) was 54.5 (13.5) years; 74.1% were female; and 86.7% presented with a renewal prescription. 73.5% of patients had major depressive disorder; 3.4% generalized anxiety disorder; and 3.4% diabetic peripheral neuropathic pain. Overall, 78.2% (95% CI: 73.1; 82.8) of patients received duloxetine for an EU-approved indication; 95.2% (95% CI: 92.1; 97.4) of patients had no contra-indication to duloxetine; and 99.0% (95% CI: 97.0; 99.8) received an approved dose. Combining these three criteria, the overall approved use of duloxetine was 73.7% (95% CI: 68.3; 78.7). The strengths and limitations of the study design are discussed.Correspondence to:
Beatrice Augendre-Ferrante, MD
Lilly France
24 Boulevard Vital Bouhot, CS 50004
92521 Neuilly sur Seine Cedex, France
Email: [email protected]
Original
Population pharmacokinetics of adefovir dipivoxil tablets in healthy Chinese volunteers
Jihan Huang, Yaping Zhang, Xiaohui Huang, Lujin Li, Yunfei Li, Kun Wang, Juan Yang, Yingchun He, Yinghua Lv, and Qingshan Zheng
Price
42.00 $
Page No. 8
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (8-14)
Population pharmacokinetics of adefovir dipivoxil tablets in healthy Chinese volunteers
Jihan Huang1*, Yaping Zhang2*, Xiaohui Huang3, Lujin Li1, Yunfei Li1, Kun Wang1,2, Juan Yang1, Yingchun He1, Yinghua Lv1, and Qingshan Zheng1
1Department of Pharmacometrics, Center for Drug Clinical Research, Shanghai University of Chinese Medicine, Shanghai, China, 2Department of Biomedical Engineering, University of Southern California, Los Angeles, CA, USA, and 3Department of Basic and Clinical Pharmacology, School of Pharmacy, Anhui Medical University, Hefei, Anhui, China
Aim: To develop a population pharmacokinetic model of adefovir dipivoxil in healthy volunteers and evaluate the effect of individual factors on the pharmacokinetics of adefovir dipivoxil. Methods: Plasma concentration data collected from 32 healthy Chinese subjects in a Phase I clinical study was pooled. Subjects received a single oral dose of 10 mg, 20 mg, or 30 mg adefovir dipivoxil, or multiple doses of 10 mg once a day for 9 days. Plasma concentrations of adefovir dipivoxil were measured using a validated liquid chromatography-mass spectrometric method. A nonlinear mixed-effect model was used to analyze the plasma concentration data of adefovir dipivoxil in healthy volunteers and to calculate the relevant parameters as well as inter- and intra-individual variability. Results: The time course of adefovir dipivoxil concentration is best described by a firstorder absorption and first-order elimination two-compartment model with lag time. The final estimate of total body clearance (CL) is 56.9 L/h and 78.7 L/h for single and multiple dosing regimen, respectively; the volume distribution of the central compartment (V2) is 106 L; inter-compartmental clearance (Q) is 220 L/h; volume distribution of the peripheral compartment (V3) is 498 L and 800 L for single and multiple dosing regimen, respectively; absorption rate is 0.509 h–1; and lag time is 0.315 hours. The inter-individual variabilities of CL and V2 were 22.4% and 58.9%, respectively. The proportional error of residual variability is 14.1% and the additive error is 0.30 ng/L. The final pharmacokinetic model was evaluated using a bootstrap method. Conclusions: A nonlinear mixed effect model for oral adefovir dipivoxil formulations was developed in healthy Chinese subjects. A multiple dosing regimen may significantly increase the body clearance and volume distribution of the peripheral compartment compared to a single dosing regimen.
*These authors contribute equally to this work.Correspondence to:
Dr. Kun Wang
Department of pharmacometrics
Center for Drug Clinical Research
Shanghai University of Chinese Medicine
Shanghai 20123, China
Email: [email protected]
Original
Comparison of methods for evaluation of the suppressive effects of prednisolone on the HPA axis and bone turnover: changes in s-DHEAS are as sensitive as the ACTH test
Eva Gruvstad, Lars Pavo Hedner, Peter Höglund, Anders Luts and Ensio Norjavaara
Price
42.00 $
Page No. 15
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (15-26)
Comparison of methods for evaluation of the suppressive effects of prednisolone on the HPA axis and bone turnover: changes in s-DHEAS are as sensitive as the ACTH test
Eva Gruvstad1, Lars Pavo Hedner2, Peter Höglund3, Anders Luts1*, and Ensio Norjavaara4,5
1AstraZeneca R&D, 2Department of Medicine, 3Department of Clinical Pharmacology, Lund University Hospital, Lund, 4AstraZeneca R&D, Mölndal, and 5Göteborg Pediatric Growth Research Center, Sahlgrenska Academy at University of Gothenburg, Göteborg, Sweden
Objective: Different hypothalamic-pituitary-adrenal (HPA) axis function tests are used for diagnosing disease and evaluating suppressive effects of corticosteroid treatment. Our objectives were to evaluate sensitivity and precision of different HPA axis tests to be able to select one that combines good performance with good practicability, suitable for investigation of new corticosteroids in clinical trials. Methods: In this descriptive, double-blind, parallel-group study, 60 healthy male volunteers were treated with once-daily morning doses of prednisolone for 2 weeks. The volunteers were randomized to 1 of 5 treatment groups (prednisolone 2.5, 5, 7.5, 10, or 15 mg). We compared the plasma-cortisol (p-cortisol) 24-hour average concentration (Cav) with morning (08:00 hours) p-cortisol, daytime p-cortisol Cav, and 24-hour urinary cortisol excretion. Adrenocorticotrophic hormone (ACTH) stimulation tests and the metyrapone test were also performed. Furthermore, we analyzed levels of serum dehydroepiandrosterone sulfate (s-DHEAS), insulin, and markers of bone turnover. Results: Doserelated effects were shown, but the magnitude of effects and sensitivities varied greatly between the tests. P-cortisol measurements over the course of 24 hours were used as the reference method. Low- and standard-dose ACTH tests and morning s-DHEAS levels had similar sensitivity. Urinary cortisol excretion and the metyrapone stimulation test had low sensitivity. The effects of prednisolone on markers of bone turnover were, in general, less than those on the HPA axis. Only osteocalcin, procollagen Type 1 Cpeptide and procollagen Type 3 N-peptide were significantly affected. Treatment with prednisolone was well tolerated. Conclusion: Changes in s-DHEAS and the low-dose ACTH test combine good sensitivity and precision for evaluation of the suppressive effect of exogenous corticosteroids on the HPA axis, and they are easy to perform.Correspondence to:
Ensio Norjavaara, MD, PhD
Clinical TA CVGI, AstraZeneca R&D
Pepparedsleden 1, 431 83 Mölndal, Sweden
Email: [email protected]
Original
Assessment of disease-drug-drug interaction between single-dose tocilizumab and oral contraceptives in women with active rheumatoid arthritis
Xiaoping Zhang, Lucy Rowell, Scott Fettner, Carol Lau and Denise Teuber
Price
42.00 $
Page No. 27
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (27-38)
Assessment of disease-drug-drug interaction between single-dose tocilizumab and oral contraceptives in women with active rheumatoid arthritis
Xiaoping Zhang1, Lucy Rowell2, Scott Fettner1, Carol Lau3 and Denise Teuber1
1Department of Clinical Pharmacology, Hoffmann-LaRoche Inc., Nutley, NJ, USA, 2Department of Biostatistics, Roche Products Ltd, Welwyn Garden City, UK and 3Department of Drug Safety, Hoffmann-LaRoche Inc., Nutley, NJ, USA
Objectives: The objective of this study was to evaluate the effect of a single intravenous dose of tocilizumab (TCZ) on pharmacokinetics (PK) of oral contraceptive (OC; norethindrone (NE) and ethinyl estradiol (EE)) and on sex hormone levels (progesterone (PG), luteinizing hormone (LH), and follicle-stimulating hormone (FSH)) in subjects with active rheumatoid arthritis (RA) who were on stable doses of methotrexate. Methods: This was an open-label, nonrandomized, multicenter, two-parallel group, one-sequence crossover study. In Group 1, Cycle 1 was a baseline cycle to determine the PK of OC and levels of sex hormones. At the start of Cycle 2, patients continued to receive OC and single TCZ dosing on Day 1. In Cycle 2, we determined the PK of OC and levels of sex hormones when OC and TCZ were combined. In Cycle 3, we determined the PK of OC and the levels of sex hormones after TCZ treatment was stopped. PK for EE and NE were analyzed serially on Day 7 when maximum TCZ effect on inflammation as indicated by C-reactiv protein (CRP) was expected. Hormone levels (PG, LH and FSH) were measured mid-cycle (cycle Days 12 – 16 and Day 21) during each cycle. Group 2 (healthy subjects) was studied to compare the levels of OC PK exposures with those in each cycle of Group 1 (RA subjects). Results: Levels of PG, LH and FSH were not affected by the combination of TCZ/OC treatment in RA patients studied. No breakthrough bleeding was attributed to the initiation of TCZ treatment in subjects receiving OCs. PK exposures of EE and NE were similar between RA and healthy subjects at baseline and were not affected by single-dose TCZ. Administration of OC with or without a single dose of TCZ was well tolerated. Conclusions: Data from this study indicated that the PK and sex hormone levels were not affected in RA subjects who had active disease and were on a stable regimen of methotrexate.Correspondence to:
Xiaoping Zhang, PhD
Department of Clinical Pharmacology
Hoffmann-La Roche, Inc.
340 Kingsland Street, Nutley, NJ 07110, USA
Email: [email protected]
Bioavailability Section
Pharmacokinetic comparison and bioequivalence evaluation of losartan/ hydrochlorothiazide tablet between Asian Indian and Japanese volunteers
Sudershan Kumar, Tausif Monif, Arshad Khuroo, Simrit Reyar, Rakesh Jain, Ajay K. Singla, and Kazuya Kurachi
Price
42.00 $
Page No. 39
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (39-54)
Pharmacokinetic comparison and bioequivalence evaluation of losartan/ hydrochlorothiazide tablet between Asian Indian and Japanese volunteers
Sudershan Kumar1, Tausif Monif1, Arshad Khuroo1, Simrit Reyar1, Rakesh Jain1, Ajay K. Singla2, and Kazuya Kurachi3
1Clinical Pharmacology and Pharmacokinetics, Ranbaxy Laboratories Limited, 2Research and Development Centre Ranbaxy Laboratories Limited, Gurgaon Haryana, India, and 3Daiichi Sankyo Espha Co., Tokyo, Japan
Objectives: To demonstrate the bioequivalence between the test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablet and evaluate the effect of ethnicity on pharmacokinetics properties of losartan, losartan carboxylic acid and hydrochlorothiazide on healthy Asian Indian and Japanese volunteers. Methods: Randomized, open-label, crossover, bioavailability studies were conducted separately in healthy Asian Indian and Japanese volunteers. One tablet either of test or of reference product was administered after 10 hours of overnight fasting. After dosing, serial blood samples were collected for a period of 48 hours for both the studies. Plasma samples were analyzed for losartan, losartan carboxylic acid and hydrochlorothiazide by a validated liquid chromatographic and mass spectrometric method (LC-MS/MS). The pharmacokinetic parameters AUC0–t, AUC0–∞, Cmax, tmax, and other pharmacokinetics parameters were determined from plasma concentrationtime profiles for both test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablets. Statistical evaluations were done to evaluate bioequivalence between generic test formulation (EPR0001) and Japanese reference product (Preminent®). Results: Losartan, losartan carboxylic acid and hydrochlorothiazide were well tolerated by subjects in all periods of each study under fasted conditions. No serious adverse events were observed. The ratios of least square means for AUC0–t and Cmax and the affiliated 90% confidence intervals were within acceptance range recommended by PMDA. Marginal differences were observed in pharmacokinetic values of Asian Indian and Japanese volunteers. Conclusions: The results of these bioavailability studies indicate that the test formulation of losartan/hydrochlorothiazide 50 + 12.5 mg (EPR0001) tablets is bioequivalent to marketed Preminent® reference formulation in Asian Indian and Japanese volunteers, when administered under fasting conditions. Both test and reference formulations were well tolerated as a single oral dose when administered to healthy adult subjects under fasted conditions. Although Asian Indian and Japanese volunteers are ethnically different, results of these studies indicate that pharmacokinetic parameters of Asian Indian and Japanese volunteers are comparable to each other in terms of bioavailability of losartan, losartan carboxylic acid and hydrochlorothiazide. Similar least square means ratios were obtained in Asian Indian and Japanese volunteers demonstrating that a bioequivalence study conducted on Japanese volunteers seems to be substituted by Asian Indian volunteers’ studies.Correspondence to:
Sudershan Kumar, M. Pharm
Plot No. GP-5, HSIDC, Sector-18,
Old Delhi – Gurgaon Road,
Gurgaon 122 015, Haryana, India
Email: [email protected]
Bioavailability Section
Pharmacokinetic comparisons between two formulations containing 100 mg of miglitol in healthy male Korean volunteers: a randomized, open-label, single-dose, two-period, twosequence crossover bioequivalence study
Hyun-Gyu Choi, Ji-Young Jeon, Yong-Jin Im, Yunjeong Kim, Haejong Jang, Seungwoo Kang, Kyeong Ho Kim4, Soo-Wan Chae, Sun Young Lee, and Min-Gul Kim
Price
42.00 $
Page No. 55
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (55-63)
Pharmacokinetic comparisons between two formulations containing 100 mg of miglitol in healthy male Korean volunteers: a randomized, open-label, single-dose, two-period, twosequence crossover bioequivalence study
Hyun-Gyu Choi1,2*, Ji-Young Jeon1,2*, Yong-Jin Im1,2, Yunjeong Kim1,2, Haejong Jang3, Seungwoo Kang3, Kyeong Ho Kim4, Soo-Wan Chae1,2,5, Sun Young Lee1,6, and Min-Gul Kim1,2
1Clinical Trial Center, 2Biomedical Research Institute, Chonbuk National University Hospital, Jeollabuk-do, 3International Scientific Standards, 4Kangwon National University, Kangwon-city, 5Department of Pharmacology, Medical School, and 6Department of Radiation Oncology, Chonbuk National University, Jeollabuk-do, Korea
Background: Miglitol is an α-glucosidase inhibitor (AGI) used as an antihyperglycemic agent in the treatment of type 2 diabetes mellitus. The mechanism is that miglitol binds to and inhibits the α-glucosidase reversibly in the proximal intestine. Thus, carbohydrates not digested in the upper small intestine are transported to the lower intestine where they are eventually digested. Objective: This study was performed for the subsequent marketing of the test miglitol formulation in Korea. We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers. Methods: A total of 40 healthy adult subjects were enrolled in this single-dose, randomized, open-label, 2-period, 2-sequence, crossover bioequivalence study. During each period, subjects received 100 mg of miglitol test or reference. Blood samples from the subjects were obtained before dosing at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 9, and 12 hours after oral drug administration. Plasma concentrations were determined by using liquid chromatography/mass spectrometry/mass spectrometry (LC-MS/MS). The PK parameters including AUCt, AUC∞, Cmax, and tmax were measured and all treatment-emergent adverse events (TEAEs) and their relationships to study these medications were recorded throughout the entire study. Results: A total of 40 healthy adult male Korean subjects were enrolled in the study and randomized into two treatment groups. Ultimately, 33 subjects completed the study. During each treatment period, blood samples were collected at specific time intervals from 0 to 12 hours after administration of a single drug dose. The PK parameters including AUCt, AUC∞, Cmax, and tmax were calculated and the 90% CIs of the ratio (test/reference) of the parameters were obtained by analysis of variance (ANOVA) on logarithmically transformed data. The 90% CIs of the geometric mean ratios for the test to reference formulations were as follows: 1.05 (0.97 – 1.13) for AUCt and 1.05 (0.96 – 1.14) for Cmax. Statistical analysis confirmed that the 90% CIs for these PK parameters were within the commonly accepted bioequivalence range of 0.8 – 1.25. There were no serious or unexpected TEAEs during the study. Conclusions: In the healthy adult Korean subjects, the test and reference formulations had similar PK parameters and similar plasma concentration-time profiles. The test formulation of miglitol met the Korean regulatory criteria (AUCt and Cmax) for assuming bioequivalence and both formulations were generally welltolerated. The CRiS identifiers: KCT0000770.
*These authors contributed equally to this work.Correspondence to:
Min-Gul Kim, MD
Biomedical Research Institute
Chonbuk National University Hospital
20, Geonji-ro, Deokjin-Gu, Jeonju-si, Jeollabuk-do, 561-712, Korea
Email: [email protected]
Bioavailability Section
Pharmacokinetic properties and bioequivalence of olmesartan medoxomil/hydrochlorothiazide in healthy Korean male subjects
Changyun Jin, Ji-Young Jeon, Yong-Jin Im, Jin-A Jung, Yunjeong Kim, KwangKyu Park, Yoonho Choi, Soo-Wan Chae, and Min-Gul Kim
Price
42.00 $
Page No. 64
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (64-72)
Pharmacokinetic properties and bioequivalence of olmesartan medoxomil/hydrochlorothiazide in healthy Korean male subjects
Changyun Jin1,2*, Ji-Young Jeon1,2*, Yong-Jin Im1,2, Jin-A Jung1,2, Yunjeong Kim1,2, KwangKyu Park3, Yoonho Choi3, Soo-Wan Chae1,2, and Min-Gul Kim1,2
1Clinical Trial Center, 2Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, and 3BioInfra Co. Ltd., Suwon, Korea
Olmesartan medoxomil inhibits the vasoconstrictor effects of angiotensin II. Hydrochlorothiazide (HCTZ) promotes sodium excretion, resulting in a reduction of plasma volume and peripheral resistance. A combination of these agents is known to have a greater effect for the treatment of hypertension than monotherapy with either one of these components. Objective: To assess bioequivalence between fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide (HCTZ) in healthy Korean subjects. Methods: 40 healthy Korean volunteers were randomized into two groups. After administration of a single dose of investigational products, blood samples were collected before study drug administration (baseline) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours after study drug administration. The plasma concentrations of olmesartan and HCTZ were measured by LC-MS/MS. The pharmacokinetic parameters were calculated, and the 90% confidence intervals (CIs) of the geometric mean ratio (test/reference) of the parameters were obtained by analysis of variance (ANOVA) on logarithmically transformed data. Results: The corresponding 90% CIs for the geometric mean ratio of the test to reference drugs were 0.93 – 1.04, 0.93 – 1.04, and 0.95 – 1.10. For HCTZ treatments, the 90% CIs for the geometric mean ratio of test to reference drugs were 0.95 – 1.03 for AUClast, 0.96 – 1.03 for AUC∞, and 0.89 – 1.04 for Cmax. Conclusion: This study demonstrated that the test and reference products met the regulatory criteria assuming bioequivalence. Both formulations were safe and well tolerated, and there were no noteworthy differences in the safety profiles of the test and reference drugs.
*These authors contributed equally to this work.Correspondence to:
Min-Gul Kim, MD
Biomedical Research Institute
Chonbuk National University Hospital
20, Geonji-ro, Deokjin-Gu, Jeonju-si, Jeollabuk-do, 561-712, Korea
Email: [email protected]
CESAR Communications: Annual Meeting of CESAR in Tuebingen, Germany June 27 – 29, 2013
Editorial
Joachim von Pawel, Matthias Schwab, and Daniel Sehrt
Page No. 73
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (73)
Editorial
Joachim von Pawel, Matthias Schwab, and Daniel Sehrt
Extended Abstract
Circulating tumor cell composition and outcome in patients with solid tumors
Ivonne Nel, Thomas Gauler, and Andreas-Claudius Hoffmann
Page No. 74
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (74-75)
Circulating tumor cell composition and outcome in patients with solid tumors
Ivonne Nel, Thomas Gauler, and Andreas-Claudius Hoffmann
Department of Medical Oncology, Molecular Oncology Risk-Profile Evaluation, West German Cancer Center, University Hospital of Essen, Essen, Germany
Correspondence to:
Priv.-Doz. Dr. med. habil. Andreas-C. Hoffmann
Department of Medical Oncology
Molecular Oncology Risk-Profile Evaluation (MORE)
West German Cancer Center
University Hospital Essen
Hufelandstraße 55, 45147 Essen, Germany
Email: [email protected]
Extended Abstract
Vascular endothelia growth factor targeted therapy may improve the effect of dendritic cell-based cancer immune therapy
Johanna Buchroithner, Josef Pichler, Christine Marosi, Georg Widhalm, Marcel Seiz-Rosenhagen, Martha Novosielski, Stefan Oberndorfer, Reinhard Ruckser, Karl Rössler, Amedeo Azizi, Gord von Campe, Karin Bordihn, and Thomas Felzmann
Page No. 76
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (76-77)
Vascular endothelia growth factor targeted therapy may improve the effect of dendritic cell-based cancer immune therapy
Johanna Buchroithner1, Josef Pichler2, Christine Marosi3, Georg Widhalm4, Marcel Seiz-Rosenhagen5, Martha Novosielski6, Stefan Oberndorfer7, Reinhard Ruckser8, Karl Rössler9, Amedeo Azizi10, Gord von Campe11, Karin Bordihn12, and Thomas Felzmann13
1Neurosurgical Department, 2Neurooncological Department, Landesnervenklinik Wagner Jauregg Linz, Linz, 3Oncological Department, 4Neurosurgical Department, Medical University Vienna, Vienna, 5Neurosurgical Department, 6Neurological Department, Medical University Innsbruck, Innsbruck, 7Neurological Department, Landesklinikum St. Pölten, St. Pölten, 8Oncological Department, Donauspital Wien, Vienna, Austria, 9Neurosurgical Department, Friedrich-Alexander-Universität Erlangen-Nürnberg, Nuremberg, Germany, 10Pediatric Department, Medical University Vienna, Vienna, 11Neurosurgical Department, Medical University Graz, Graz, 12Neurosurgical Department, Medical University Salzburg, Salzburg, and 13Activartis Biotech GmbH Wien, Vienna, Austria
Correspondence to:
Dr. Johanna Buchroithner
Neurosurgical Department
Landesnervenklinik Wagner Jauregg, Neurochirurgie
Wagner-Jauregg-Weg 15, 4020 Linz, Austria
Email: [email protected]
Extended Abstract
Liposomal cisplatin can overcome chemotherapy resistance of A2780 ovarian cancer cells by inducing the extrinsic apoptotic pathway
Daniel P. Stölting, Martin Koch, Michael Wiese, Hans-Dieter Royer, and Gerd Bendas
Page No. 78
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (78-81)
Liposomal cisplatin can overcome chemotherapy resistance of A2780 ovarian cancer cells by inducing the extrinsic apoptotic pathway
Daniel P. Stölting1, Martin Koch1, Michael Wiese1, Hans-Dieter Royer2, and Gerd Bendas1
1Pharmaceutical Institute, University Bonn, Bonn, and 2Institute of Human Genetics and Anthropology, Medical Faculty, Heinrich-Heine University Düsseldorf, Germany
Correspondence to:
Daniel Philipp Stölting
WG Prof. Gerd Bendas
Pharmaceutical Department
University of Bonn
An der Immenburg 4, 53121 Bonn, Germany
Email: [email protected]
Extended Abstract
Drug resistance mediated changes in lymphendothelial tumor cell intravasation
Daniel Senfter, Nicole Huttary, Georg Krupitza, Helmut Dolznig, and Robert M. Mader
Page No. 82
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (82-84)
Drug resistance mediated changes in lymphendothelial tumor cell intravasation
Daniel Senfter1,2,3, Nicole Huttary1, Georg Krupitza1, Helmut Dolznig2, and Robert M. Mader3
1Institute of Clinical Pathology, Comprehensive Cancer Center of the Medical University of Vienna, 2Institute of Medical Genetics, Medical University of Vienna, and 3Department of Medicine I, Comprehensive Cancer Center of the Medical University of Vienna, Austria
Correspondence to:
Ao. Univ.-Prof. Dipl.Ing. Dr. Robert Mader
Universitätsklinik für Innere Medizin I
Währinger Gürtel 18 - 20, 1090 Vienna, Austria
Email: [email protected]
Extended Abstract
microRNA expression profiles distinguish colorectal cancer patients in two regions of Austria
Marlies I. Moshammer, Maria Kalipciyan, Felix Offner, William Sterlacci, Günther G. Steger, Robert M. Mader, and Roland Sedivy
Page No. 85
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (85-86)
microRNA expression profiles distinguish colorectal cancer patients in two regions of Austria
Marlies I. Moshammer1, Maria Kalipciyan1, Felix Offner2, William Sterlacci2, Günther G. Steger1, Robert M. Mader1, and Roland Sedivy3,4
1Department of Medicine I, Comprehensive Cancer Center of the Medical University of Vienna, Vienna, 2Department of Pathology, Landeskrankenhaus Feldkirch, Feldkirch, 3Department of Clinical Pathology, Landesklinikum/Clinical Center St. Pölten, St. Pölten, and 4Center of Pathology, Danube Private University, Krems/Donau, Austria
Correspondence to:
Ao. Univ.-Prof. Dipl.-Ing. Dr. Robert Mader
Universitätsklinik für Innere Medizin I
Währinger Gürtel 18-20, 1090 Vienna, Austria
Email: [email protected]
Extended Abstract
Exosomal microRNA transfer varies with specific microRNAs functional in colorectal cancer and cellular differentiation
Marlies I. Moshammer, Maria Kalipciyan, Rupert Bartsch, Günther G. Steger, Roland Sedivy, and Robert M. Mader
Page No. 87
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (87-88)
Exosomal microRNA transfer varies with specific microRNAs functional in colorectal cancer and cellular differentiation
Marlies I. Moshammer1, Maria Kalipciyan1, Rupert Bartsch1, Günther G. Steger1, Roland Sedivy2,3, and Robert M. Mader1
1Department of Medicine I, Comprehensive Cancer Center of the Medical University of Vienna, Vienna, 2Department of Clinical Pathology, Landesklinikum/Clinical Center St. Pölten, St. Pölten, and 3Center of Pathology, Danube Private University, Krems/Donau Austria
Correspondence to:
Ao. Univ.-Prof. Dipl.-Ing. Dr. Robert Mader
Universitätsklinik für Innere Medizin I
Währinger Gürtel 18-20, 1090 Vienna, Austria
Email: [email protected]
Extended Abstract
A systems pharmacology approach to improve drug therapy in NSCLC: Establishing a CESAR network
Ganna V. Kalayda, Martin Michaelis, Jindrich Cinatl jr., Robert M. Mader, Holger Fröhlich, Navin Sarin, Johanna Melin, Florian Engel, Walter Jäger, Roland Frötschl, Ulrich Jaehde, Charlotte Kloft, and Christoph A. Ritter
Page No. 89
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (89-91)
A systems pharmacology approach to improve drug therapy in NSCLC: Establishing a CESAR network
Ganna V. Kalayda1, Martin Michaelis2, Jindrich Cinatl jr.3, Robert M. Mader4, Holger Fröhlich5, Navin Sarin1, Johanna Melin6, Florian Engel7, Walter Jäger8, Roland Frötschl7, Ulrich Jaehde1, Charlotte Kloft6, and Christoph A. Ritter9
1Institute of Pharmacy, Clinical Pharmacy, University of Bonn, Bonn, Germany, 2Centre for Molecular Processing and School of Biosciences, University of Kent, Canterbury, UK, 3Institut für Medizinische Virologie, Klinikum der Goethe- Universität, Frankfurt/Main, Germany, 4Department of Medicine I, Comprehensive Cancer Center of the Medical University of Vienna, Austria, 5Algorithmic Bioinformatics, University of Bonn, Bonn, 6Department of Clinical Pharmacy and Biochemistry, Freie Universität Berlin, 7Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany, 8Department of Clinical Pharmacy and Diagnostics, University of Vienna, Austria, and 9Clinical Pharmacy, Institute of Pharmacy, University of Greifswald, Germany
Correspondence to:
Prof. Dr. Christoph Ritter
Ernst-Moritz-Arndt-Universität Greifswald
Institut für Pharmazie, Klinische Pharmazie
Friedrich-Ludwig-Jahn-Str. 17, 17487 Greifswald, Germany
Email: [email protected]
Extended Abstract
NSCLC cells adapted to EGFR inhibition accumulate EGFR interacting proteins and down-regulate microRNA related to epithelial-mesenchymal transition
Robert M. Mader, Sarah Foerster, Navin Sarin, Martin Michaelis, Jindrich Cinatl jr., Charlotte Kloft, Holger Fröhlich, Florian Engel, Ganna V. Kalayda, Walter Jäger, Roland Frötschl, Ulrich Jaehde, and Christoph A. Ritter
Page No. 92
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 1/2014 (92-94)
NSCLC cells adapted to EGFR inhibition accumulate EGFR interacting proteins and down-regulate microRNA related to epithelial-mesenchymal transition
Robert M. Mader1, Sarah Foerster2, Navin Sarin3, Martin Michaelis4, Jindrich Cinatl jr.5, Charlotte Kloft6, Holger Fröhlich7, Florian Engel8, Ganna V. Kalayda3, Walter Jäger9, Roland Frötschl8, Ulrich Jaehde3, and Christoph A. Ritter2
1Department of Medicine I, Comprehensive Cancer Center of the Medical University of Vienna, Vienna, Austria, 2Clinical Pharmacy, Institute of Pharmacy, University of Greifswald, Greifswald, 3Institute of Pharmacy, Clinical Pharmacy, University of Bonn, Bonn, Germany, 4Centre for Molecular Processing and School of Biosciences, University of Kent, Canterbury, UK, 5Institut für Medizinische Virologie, Klinikum der Goethe-Universität, Frankfurt/Main, 6Department of Clinical Pharmacy and Biochemistry, Freie Universität Berlin, Berlin, 7Algorithmic Bioinformatics, University of Bonn, 8Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany, and 9Department of Clinical Pharmacy and Diagnostics, University of Vienna, Austria
Correspondence to:
Prof. Dr. Christoph Ritter
Ernst-Moritz-Arndt-Universität Greifswald
Institut für Pharmazie, Klinische Pharmazie
Friedrich-Ludwig-Jahn-Str. 17, 17487 Greifswald, Germany
Email: [email protected]
