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1

Sample size determination for bioequivalence assessment using a multiplicative model

Dieter Hauschke, Volker W. Steinijans, Edgar Diletti, Martin Burke

Journal:

Journal of Pharmacokinetics and Pharmacodynamics

Year:

1992

Language:

english

File:

PDF, 211 KB

english, 1992

2

Silica coated iron oxide nanoparticles-induced cytotoxicity, genotoxicity and its underlying mechanism in human HK-2 renal proximal tubule epithelial cells

Královec, Karel, Havelek, Radim, Kročová, Eliška, Kučírková, Lucie, Hauschke, Martina, Bartáček, Jan, Palarčík, Jiří, Sedlák, Miloš

Journal:

Mutation Research/Genetic Toxicology and Environmental Mutagenesis

Year:

2019

Language:

english

File:

PDF, 1.97 MB

english, 2019

3

The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research-based pharmaceutical company

Dieter Hauschke, Volker W. Steinijans

Journal:

Statistics in Medicine

Year:

2000

Language:

english

File:

PDF, 55 KB

english, 2000

4

The time course of motor cortex plasticity after spaced motor practice

Igor Delvendahl, Nicola G. Kuhnke, Nikolai H. Jung, Florian Mainberger, Matthias Cronjaeger, Josef Unterrainer, Dieter Hauschke, Volker Mall

Journal:

Brain Stimulation

Year:

2011

Language:

english

File:

PDF, 319 KB

english, 2011

5

Navigated transcranial magnetic stimulation does not decrease the variability of motor-evoked potentials

Nikolai H. Jung, Igor Delvendahl, Nicola G. Kuhnke, Dieter Hauschke, Sabine Stolle, Volker Mall

Journal:

Brain Stimulation

Year:

2010

Language:

english

File:

PDF, 359 KB

english, 2010

6

Trace fossils versus pseudofossils in Lower Triassic playa deposits, Germany

Dirk Knaust, Norbert Hauschke

Journal:

Palaeogeography, Palaeoclimatology, Palaeoecology

Year:

2004

Language:

english

File:

PDF, 587 KB

english, 2004

7

Automated Analysis of Urinary Stone Composition Using Raman Spectroscopy: Pilot Study for the Development of a Compact Portable System for Immediate Postoperative Ex Vivo Application

Miernik, Arkadiusz, Eilers, Yvan, Bolwien, Carsten, Lambrecht, Armin, Hauschke, Dieter, Rebentisch, Gunter, Lossin, Phillipp S., Hesse, Albrecht, Rassweiler, Jens J., Wetterauer, Ulrich, Schoenthaler,

Journal:

The Journal of Urology

Year:

2013

Language:

english

File:

PDF, 1.09 MB

english, 2013

8

Metrics to Characterize Concentration-Time Profiles in Single- and Multiple-Dose Bioequivalence Studies

Steinijans, V. W., Sauter, R., Hauschke, D., Elze, M.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

1995

Language:

english

File:

PDF, 504 KB

english, 1995

9

KURFÜRST JOHANN FRIEDRICH VON SACHSEN UND DER ASTRONOM UND MATHEMATIKER JOHANNES SCHÖNER: DAS GLOBENPAAR VON 1533/1534 IN WEIMAR

Journal:

Der Globusfreund

Year:

2003-2005

Language:

german

File:

PDF, 1.26 MB

german, 2003-2005

10

Earliest record of exophytic insect oviposition on plant material from the latest Pennsylvanian (Gzhelian, Stephanian C) of the Saale Basin, Germany

Laaß, Michael, Hauschke, Norbert

Journal:

Palaeogeography, Palaeoclimatology, Palaeoecology

Year:

2019

Language:

english

File:

PDF, 14.29 MB

english, 2019

11

Sample size determination for proving equivalence based on the ratio of two means for normally distributed data

Dieter Hauschke, Meinhard Kieser, Edgar Diletti, Martin Burke

Journal:

Statistics in Medicine

Year:

1999

Language:

english

File:

PDF, 137 KB

english, 1999

12

Proof of Safety in Toxicology Based on the Ratio of Two Means for Normally Distributed Data

Dieter Hauschke, Meinhard Kieser, Ludwig A. Hothorn

Journal:

Biometrical Journal

Year:

1999

Language:

english

File:

PDF, 161 KB

english, 1999

13

Biostatistical Assessment of Mutagenicity Studies by Including the Positive Control

Dieter Hauschke, Renate Slacik-Erben, Sabrina Hensen, Ronny Kaufmann

Journal:

Biometrical Journal

Year:

2005

Language:

english

File:

PDF, 84 KB

english, 2005

14

S32.3: Regulatory guidelines and their statistical impact on respiratory trials

Dieter Hauschke

Journal:

Biometrical Journal

Year:

2004

Language:

english

File:

PDF, 73 KB

english, 2004

15

Establishing Efficacy of a New Experimental Treatment in the ‘Gold Standard’ Design

Dieter Hauschke, Iris Pigeot

Journal:

Biometrical Journal

Year:

2005

Language:

english

File:

PDF, 71 KB

english, 2005

16

Rejoinder to “Establishing Efficacy of a New Experimental Treatment in the ‘Gold Standard’ Design”

Dieter Hauschke, Iris Pigeot

Journal:

Biometrical Journal

Year:

2005

Language:

english

File:

PDF, 45 KB

english, 2005

17

Letter to the Editor

Joachim Röhmel, Dieter Hauschke

Journal:

Biometrical Journal

Year:

2006

Language:

english

File:

PDF, 51 KB

english, 2006

18

Book Review: Biostatistik 2. By M. Precht and R. Kraft

Dieter Hauschke

Journal:

Biometrical Journal

Year:

2006

Language:

english

File:

PDF, 30 KB

english, 2006

19

Effects of Lung Surfactant Factor (LSF) Treatment on Gas Exchange and Histopathological Changes in an Animal Model of Adult Respiratory Distress Syndrome (ARDS): Comparison of Recombinant LSF with Bovine LSF

D. Häfner, P.-G. Germann, D. Hauschke

Journal:

Pulmonary Pharmacology

Year:

1994

File:

PDF, 1.01 MB

1994

20

Characterisation of the rat lung lavage model as biological assay for testing the activity of surfactant preparations

Dietrich Häfner, Martin Burke, Karl Schick, Dieter Hauschke

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

1999

Language:

english

File:

PDF, 161 KB

english, 1999

21

A nonparametric test for proving noninferiority in clinical trials with ordered categorical data

Ullrich Munzel, Dieter Hauschke

Journal:

Pharmaceutical Statistics

Year:

2003

Language:

english

File:

PDF, 154 KB

english, 2003

22

Assessment of clinical relevance by considering point estimates and associated confidence intervals

Meinhard Kieser, Dieter Hauschke

Journal:

Pharmaceutical Statistics

Year:

2005

Language:

english

File:

PDF, 166 KB

english, 2005

23

Letter to the editor

Dieter Hauschke, Dietrich Knoerzer

Journal:

Pharmaceutical Statistics

Year:

2006

Language:

english

File:

PDF, 232 KB

english, 2006

24

Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo

Iris Pigeot, Juliane Schäfer, Joachim Röhmel, Dieter Hauschke

Journal:

Statistics in Medicine

Year:

2003

Language:

english

File:

PDF, 145 KB

english, 2003

25

Paleolimulus fuchsbergensisn. sp. (Xiphosura, Merostomata) aus der oberen Trias von Nordwestdeutschland, mit einer Übersicht zur Systematik und Verbreitung rezenter Limuliden

Norbert Hauschke, Volker Wilde

Journal:

Paläontologische Zeitschrift

Year:

1987

File:

PDF, 3.46 MB

1987

26

Biometrische Verfahren zum Wirksamkeitsnachweis im Zulassungsverfahren

J. Röhmel, D. Hauschke, A. Koch, I. Pigeot

Journal:

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Year:

2005

Language:

german

File:

PDF, 791 KB

german, 2005

27

Internuclear chromosome distribution of dysplastic megakaryocytes in myelodysplastic syndromes is dependent on the level of ploidy

Claudia Münch, Annette M. May, Dieter Hauschke, Jasmine Roth, Silke Lassmann, Martin Werner

Journal:

Year:

2011

Language:

english

File:

PDF, 613 KB

english, 2011

28

Sensory irritations and pulmonary effects in human volunteers following short-term exposure to pinewood emissions

Richard Gminski, Rainer Marutzky, Sebastian Kevekordes, Frank Fuhrmann, Werner Bürger, Dieter Hauschke, Winfried Ebner, Volker Mersch-Sundermann

Journal:

Journal of Wood Science

Year:

2011

Language:

english

File:

PDF, 406 KB

english, 2011

29

Template-based synoptic reports improve the quality of pathology reports of prostatectomy specimens

Konrad Aumann, Dominic Amann, Vera Gumpp, Dieter Hauschke, Gian Kayser, Annette M May, Ulrich Wetterauer, Martin Werner

Journal:

Year:

2012

Language:

english

File:

PDF, 337 KB

english, 2012

30

Bioequivalence and Statistics in Clinical Pharmacology

Dieter Hauschke

Journal:

Year:

2006

Language:

english

File:

PDF, 226 KB

english, 2006

31

Comparison of rSP-C surfactant with natural and synthetic surfactants after late treatment in a rat model of the acute respiratory distress syndrome

Dietrich Häfner, Paul-Georg Germann, Dieter Hauschke

Journal:

British Journal of Pharmacology

Year:

1998

Language:

english

File:

PDF, 448 KB

english, 1998

32

Letter to the Editor: A Note on Sample Size Calculation in Bioequivalence Trials

Dieter Hauschke

Journal:

Journal of Pharmacokinetics and Pharmacodynamics

Year:

2002

Language:

english

File:

PDF, 134 KB

english, 2002

33

Occurrence of Aurora A positive multipolar mitoses in distinct molecular classes of colorectal carcinomas and effect of Aurora A inhibition

Corinna Herz, Fabienne Schlürmann, Daniela Batarello, Christiane D. Fichter, Anja Schöpflin, Claudia Münch, Dieter Hauschke, Martin Werner, Silke Lassmann

Journal:

Molecular Carcinogenesis

Year:

2012

Language:

english

File:

PDF, 1.19 MB

english, 2012

34

Comment on: Updates of bioequivalence programs (including statistical power approximated by Student's t)

Dieter Hauschke

Journal:

Computer Methods and Programs in Biomedicine

Year:

1995

Language:

english

File:

PDF, 76 KB

english, 1995

35

A note on conventional null hypothesis testing in active control equivalence studies

Dieter Hauschke, Volker W. Steinijans

Journal:

Controlled Clinical Trials

Year:

1996

Language:

english

File:

PDF, 237 KB

english, 1996

36

Determination of power and sample size for proving equivalence based on the ratio of two means for normally distributed data

Meinhard Kieser, Dieter Hauschke

Journal:

Controlled Clinical Trials

Year:

1998

Language:

english

File:

PDF, 64 KB

english, 1998

37

Intratracheally applied rSP-C surfactant exhibits no anaphylactic shock reactions in a guinea pig model of acute lung hypersensitivity

Paul-Georg Germann, Jörg Kemkowski, Dieter Hauschke, Wolfram Steinhilber, Dietrich Häfner

Journal:

Experimental and Toxicologic Pathology

Year:

1999

Language:

english

File:

PDF, 3.82 MB

english, 1999

38

A Review of: “Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition, by S.-C. Chow and J.-P. Liu” : Boca Raton, FL: Chapman & Hall/CRC, 2009, ISBN 978-1-58488-668-6, xxii + 733 pp., $99.95.

Hauschke, Dieter

Journal:

Journal of Biopharmaceutical Statistics

Year:

2009

Language:

english

File:

PDF, 50 KB

english, 2009

39

Effects of Early Treatment with rSP-C Surfactant on Oxygenation and Histology in Rats with Acute Lung Injury

D. Häfner, P.- G. Germann, D. Hauschke, U. Kilian

Journal:

Pulmonary Pharmacology & Therapeutics

Year:

1999

Language:

english

File:

PDF, 533 KB

english, 1999

40

The immunohistochemical staining pattern of Gab2 correlates with distinct stages of chronic myeloid leukemia

Konrad Aumann, Silke Lassmann, Anja Schöpflin, Annette M. May, Franziska U. Wöhrle, Robert Zeiser, Cornelius F. Waller, Dieter Hauschke, Martin Werner, Tilman Brummer

Journal:

Human Pathology

Year:

2011

Language:

english

File:

PDF, 846 KB

english, 2011

41

First Late Triassic Record of a Paleoentomofauna from South America (Malargüe Basin, Mendoza Province, Argentina)

Carsten BRAUCKMANN, Oscar F. GALLEGO, Norbert HAUSCHKE, Rafael G. MARTINS-NETO, Elke GROENING, Jan-M. ILGER, María B. LARA

Journal:

Acta Geologica Sinica - English Edition (Wiley-Blackwell)

Year:

2010

Language:

english

File:

PDF, 6.66 MB

english, 2010

42

Summary of discussion on effects of physical agents on tumor nuclei

Theodore S. Hauschk

Journal:

Experimental Cell Research

Year:

1963

Language:

english

File:

PDF, 302 KB

english, 1963

43

DNA-Quantifizierung in der forensischen Spurenkunde

R. Pflugradt, T. Sänger, N. Schlauderer, D. Hauschke, S. Lutz-Bonengel…

Journal:

Year:

2012

Language:

german

File:

PDF, 716 KB

german, 2012

44

Investigation of a Potential Food Effect on the Pharmacokinetics of Roflumilast, an Oral, Once-Daily Phosphodiesterase 4 Inhibitor, in Healthy Subjects

Hauns, Bernhard, Hermann, Robert, Hünnemeyer, Andreas, Herzog, Rolf, Hauschke, Dieter, Zech, Karl, Bethke, Thomas D.

Journal:

Journal of Clinical Pharmacology

Year:

2006

Language:

english

File:

PDF, 97 KB

english, 2006

45

The Bootstrap in Bioequivalence Studies

Pigeot, Iris, Hauschke, Dieter, Shao, Jun

Journal:

Journal of Biopharmaceutical Statistics

Year:

2011

Language:

english

File:

PDF, 153 KB

english, 2011

46

Somatropin treatment of spinal muscular atrophy: A placebo-controlled, double-blind crossover pilot study

Kirschner, J., Schorling, D., Hauschke, D., Rensing-Zimmermann, C., Wein, U., Grieben, U., Schottmann, G., Schara, U., Konrad, K., Müller-Felber, W., Thiele, S., Wilichowski, E., Hobbiebrunken, E., St

Journal:

Neuromuscular Disorders

Year:

2014

Language:

english

File:

PDF, 914 KB

english, 2014

47

ID2 and ID3 protein expression mirrors granulopoietic maturation and discriminates between acute leukemia subtypes

May, Annette M., Frey, Anna-Verena, Bogatyreva, Lioudmila, Benkisser-Petersen, Marco, Hauschke, Dieter, Lübbert, Michael, Wäsch, Ralph, Werner, Martin, Hasskarl, Jens, Lassmann, Silke

Journal:

Histochemistry and Cell Biology

Year:

2014

Language:

english

File:

PDF, 541 KB

english, 2014

48

Differenzialdiagnose myelproliferativer Neoplasien

Aumann, K., Frey, A.-V., May, A.M., Hauschke, D., Kreutz, C., Marx, J.P., Timmer, J., Werner, M., Pahl, H.L.

Journal:

Year:

2013

Language:

german

File:

PDF, 1.19 MB

german, 2013

49

Bioequivalence Studies in Drug Development || Front Matter

Hauschke, Dieter, Steinijans, Volker, Pigeot, Iris

Year:

2007

Language:

english

File:

PDF, 179 KB

english, 2007

50

Comparison of Prasugrel and Bivalirudin vs Clopidogrel and Heparin in Patients With ST-Segment Elevation Myocardial Infarction: Design and Rationale of the Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 Trial

Schulz, Stefanie, Richardt, Gert, Laugwitz, Karl-Ludwig, Mehran, Roxana, Gershlick, Anthony H., Morath, Tanja, Mayer, Katharina, Neudecker, Julia, Tölg, Ralph, Ibrahim, Tareq, Hauschke, Dieter, Braun,

Journal:

Clinical Cardiology

Year:

2014

Language:

english

File:

PDF, 203 KB

english, 2014