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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

Pharmacokinetic characterization of controlled-release formulations

V. W. Steinijans

Journal:

European Journal of Drug Metabolism and Pharmacokinetics

Year:

1990

Language:

english

File:

PDF, 867 KB

english, 1990

3

Some Conceptual Issues in the Evaluation of Average, Population, and Individual Bioequivalence

Steinijans, V. W.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2001

Language:

english

File:

PDF, 558 KB

english, 2001

4

Differences in pH-Dependent Activation Rates of Substituted Benzimidazoles and Biological in vitro Correlates

Kromer, W., Kr&uuml, ger, U., Huber, R., Hartmann, M., Steinijans, V.W.

Journal:

Year:

1998

Language:

english

File:

PDF, 260 KB

english, 1998

5

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

6

The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research-based pharmaceutical company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

7

Sustained release properties of the once daily theophylline capsule BY912 as compared with Theo–24® capsules

J. H. G. Jonkman, V. W. Steinijans, W. Beier, W. J. V. Van Der Boon, G. Crasmeijer

Journal:

Biopharmaceutics & Drug Disposition

Year:

1989

Language:

english

File:

PDF, 422 KB

english, 1989

8

An M1-selective muscarinic receptor antagonist telenzepine improves lung function in patients with chronic obstructive bronchitis

M. Cazzola, G. D'Amato, E. Guidetti, H. Staudinger, V.W. Steinijans, U. Kilian

Journal:

Pulmonary Pharmacology

Year:

1990

Language:

english

File:

PDF, 426 KB

english, 1990

9

Effect of ciclesonide on allergen challenge in subjects with bronchial asthma

B. B. Larsen, L. P. Nielsen, R. Engelstätter, V. Steinijans, R. Dahl

Journal:

Year:

2003

Language:

english

File:

PDF, 144 KB

english, 2003

10

Lack of pharmacokinetic interaction of pantoprazole with diazepam in man

R. GUGLER, M. HARTMANN, J. RUDI, I. BROD, R. HUBER, V. W. STEINIJANS, H. BLIESATH, W. WURST, U. KLOTZ

Journal:

British Journal of Clinical Pharmacology

Year:

1996

Language:

english

File:

PDF, 219 KB

english, 1996

11

Pharmacodynamics and pharmacokinetics of three different doses of urapidil infused in hypertensive patients

R. Kirsten, K. Nelson, J. Neff, R. Haerlin, V. Steinijans, H. W. Radtke

Journal:

European Journal of Clinical Pharmacology

Year:

1986

Language:

english

File:

PDF, 382 KB

english, 1986

12

Pharmacokinetics of theophylline in patients following short-term intravenous infusion

V. W. Steinijans, R. Eicke, J. Ahrens

Journal:

European Journal of Clinical Pharmacology

Year:

1982

Language:

english

File:

PDF, 689 KB

english, 1982

13

A non-parametric confidence interval method

A. Racine-Poon, A. P. Grieve, V. W. Steinijans, E. Diletti

Journal:

European Journal of Clinical Pharmacology

Year:

1985

Language:

english

File:

PDF, 293 KB

english, 1985

14

Absolute bioavailability of theophylline from a sustained-release formulation using different intravenous reference infusions

V. W. Steinijans, H. -U. Schulz, A. Böhm, W. Beier

Journal:

European Journal of Clinical Pharmacology

Year:

1987

Language:

english

File:

PDF, 403 KB

english, 1987

15

Equivalence concepts in clinical trials

V. W. Steinijans, M. Neuhäuser, F. Bretz

Journal:

European Journal of Drug Metabolism and Pharmacokinetics

Year:

2000

Language:

english

File:

PDF, 361 KB

english, 2000

16

Lack of pharmacodynamic and pharmacokinetic interaction between pantoprazole and phenprocoumon in man

A. Ehrlich, H. Fuder, M. Hartmann, G. Wieckhorst, W. Timmer, R. Huber, M. Birkel, H. Bliesath, V. W. Steinijans, W. Wurst, P. W. Lücker

Journal:

European Journal of Clinical Pharmacology

Year:

1996

Language:

english

File:

PDF, 105 KB

english, 1996

17

Dynamic responses to intravenous urapidil and dihydralazine in normal subjects*

Belz, Gustav G, Matthews, Jennifer H, Graf, Detlef, Stern, Heiko C, Bachmann, Renate, Belz, Gudrun, Steinijans, Volker W, Palm, Dieter

Journal:

Clinical Pharmacology & Therapeutics

Year:

1985

Language:

english

File:

PDF, 473 KB

english, 1985

18

The influence of caffeine on the steady-state pharmacokinetics of theophylline

Jonkman, Jan H G, Sollie, Frans A E, Sauter, Rita, Steinijans, Volker W

Journal:

Clinical Pharmacology & Therapeutics

Year:

1991

Language:

english

File:

PDF, 567 KB

english, 1991

19

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

20

Pharmacokinetic interaction of isopropylaminophenazone and phenylbutazone in the horse

EDUARD JENNY, VOLKER W. STEINIJANS, PHILIPPE SEIFERT

Journal:

Journal of Veterinary Pharmacology and Therapeutics

Year:

1979

Language:

english

File:

PDF, 433 KB

english, 1979

21

Inhibition of gluconeogenesis in isolated perfused rat liver by clanobutin

H. Wolf, J. Schlepper, V. Steinijans, R. Scholz

Journal:

Biochemical Pharmacology

Year:

1980

Language:

english

File:

PDF, 492 KB

english, 1980

22

Ciclesonide is more effective than budesonide in the treatment of persistent asthma

Dieter Ukena, Christian Biberger, Volker Steinijans, Volker von Behren, Ronitta Malek, Hans H. Weber, Ekkehard Beck, Anneliese Linnhoff

Journal:

Pulmonary Pharmacology & Therapeutics

Year:

2007

Language:

english

File:

PDF, 263 KB

english, 2007

23

Bioequivalence of 2 sustained release preparation of isosorbide-5-mononitrate

J. Bron, J.H.G. Jonkman, V.W. Steinijans, E. Dileti

Journal:

European Journal of Pharmaceutical Sciences

Year:

1996

Language:

english

File:

PDF, 181 KB

english, 1996

24

Pantoprazole does not interact with diclofenac

H. Bleisath, R. Huber, M. Hartmann, V.W. Steinijans, H.J. Koch, W. Wurst

Journal:

Gastroenterology

Year:

1995

Language:

english

File:

PDF, 159 KB

english, 1995

25

Lack of pharmacokinetic and pharmacodynamic interaction of pantoprazole and phenprocoumon in man

A. Ehrlich, H. Fuder, M. Hartmann, W. Timmer, R. Huber, M. Birkel, H. Bliesath, V.W. Steinijans, W. Wurst, P.W. Lücker

Journal:

Gastroenterology

Year:

1995

Language:

english

File:

PDF, 151 KB

english, 1995

26

Lack of effect of pantoprazole on the pharmacodynamics and pharmacokinetics of warfarin [see comments]

L. Duursema, FO Muller, R. Schall, MV Middle, HK Hundt, G. Groenewoud, VW Steinijans, H. Bliesath

Journal:

British Journal of Clinical Pharmacology

Year:

1995

Language:

english

File:

PDF, 610 KB

english, 1995

27

Equivalent Pharmacokinetics of the Active Metabolite of Ciclesonide With and Without Use of the AeroChamber Plus™ Spacer for Inhalation

Dr Anton Drollmann, Ruediger Nave, Volker W. Steinijans, Eugen Baumgärtner, Thomas D. Bethke

Journal:

Clinical Pharmacokinetics

Year:

2006

Language:

english

File:

PDF, 131 KB

english, 2006

28

Lack of Pharmacokinetic and Pharmacodynamic Interaction Between Pantoprazole and Glibenclamide in Humans

Prof. I. E. Walter-Sack, H. Bliesath, F. Stötzer, R. Huber, V. W. Steinijans, R. Ding, H. Mascher, W. Wurst

Journal:

Clinical Drug Investigation

Year:

1998

Language:

english

File:

PDF, 277 KB

english, 1998

29

Bioequivalence Studies in Drug Development || Front Matter

Hauschke, Dieter, Steinijans, Volker, Pigeot, Iris

Year:

2007

Language:

english

File:

PDF, 179 KB

english, 2007

30

Sustained release properties of the once daily theophylline capsule euphylong as compared with theo-dur tablets

Kerkhof, F.A., de Noord, O.E., Grasmeyer, G., Jonkman, J.H.G., Steinijans, V.W., Beier, W., Yska, J.P.

Journal:

International Journal of Pharmaceutics

Year:

1988

Language:

english

File:

PDF, 437 KB

english, 1988

31

Controlled-Release Theophylline Inhibits Early Morning Airway Obstruction and Hyperresponsivenes in Asthmatic Subjects

Crescioli, S, Carobbo, A Dal, Maestrelli, P, Boschetto, P, Santagada, T, Steinijans, VW, Hurst, TS, Parise, G, Fabbri, LM

Journal:

Annals of Allergy, Asthma & Immunology

Year:

1996

Language:

english

File:

PDF, 165 KB

english, 1996

32

A Note on Welch's Approximate t-Solution to Bioequivalence Assessment

Dieter Hauschke, Volker W. Steinijans and Ludwig A. Hothorn

Journal:

Year:

1996

Language:

english

File:

PDF, 243 KB

english, 1996

33

International Harmonization of Regulatory Bioequivalence Requirements

Steinijans, V. W., Hauschke, D.

Journal:

Clinical Research and Regulatory Affairs

Year:

1993

Language:

english

File:

PDF, 954 KB

english, 1993

34

Therapeutic Advantage of Unequal Dosing of Theophylline in Patients With Nocturnal asthma

Dorow, P., Steinijans, V. W.

Journal:

Chronobiology International

Year:

1987

Language:

english

File:

PDF, 580 KB

english, 1987

35

Controversies in Bioequivalence Studies

Dr Volker W. Steinijans,Dieter Hauschke,Jan H. G. Jonkman

Journal:

Clinical Pharmacokinetics

Year:

1992

Language:

english

File:

PDF, 839 KB

english, 1992

36

Efficacy of Once-Daily Urapidil Treatment in Mild or Moderate Essential Hypertension Assessed by Ambulatory 24-Hour Blood Pressure Monitoring

Dr Bruno Trimarcö,G. Rosiello,P. Feldhaus,V. W. Steinijans,F. Vecchione…

Journal:

Year:

1988

Language:

english

File:

PDF, 1.17 MB

english, 1988

37

Acute Effects of Urapidil on Airway Response in Hypertensive Patients with Chronic Obstructive Pulmonary Disease

Prof. Dr M. Cazzola,A. Spinazzi,G. Santangelo,V. W. Steinijans,W. Wurst…

Journal:

Year:

1990

Language:

english

File:

PDF, 461 KB

english, 1990

38

Circadian Rhythm of Serum Cortisol after Repeated Inhalation of the New Topical Steroid Ciclesonide

Weinbrenner, Anita, Hüneke, Dagny, Zschiesche, Michael, Engel, Georg, Timmer, Wolfgang, Steinijans, Volker W., Bethke, Thomas, Wurst, Wilhelm, Drollmann, Anton, Kaatz, Hans Joachim, Siegmund, Werner

Journal:

Journal of Clinical Endocrinology & Metabolism

Year:

2002

Language:

english

File:

PDF, 94 KB

english, 2002

39

Steady State Pharmacokinetics, Metabolism and Pharmacodynamics of Theophylline in Children After Unequal Twice-Daily Dosing of a New Sustained-Release Formulation

Reinhardt, D., Berdel, D., Heimann, G., Kusenbach, G., Berg, A. von, Johnson, E., Steinijans, V. W., Staudinger, H.

Journal:

Chronobiology International

Year:

1987

Language:

english

File:

PDF, 770 KB

english, 1987

40

Theophylline Steady-State Pharmacokinetics: Recent Concepts and Their Application in Chronotherapy of Reactive Airway Diseases

Steinijans, V. W., Trautmann, H., Johnson, E., Beier, W.

Journal:

Chronobiology International

Year:

1987

Language:

english

File:

PDF, 943 KB

english, 1987

41

Directional decision for a two-tailed alternative

Hauschke, Dieter, Steinijans, Volker W.

Journal:

Journal of Biopharmaceutical Statistics

Year:

1996

Language:

english

File:

PDF, 108 KB

english, 1996

42

Chrono-Optimization of the Time of Evening Administration with Unequally Divided Twice-Daily Theophylline

Kunkel, G., Steinijans, V. W., Borner, K.

Journal:

Chronobiology International

Year:

1987

Language:

english

File:

PDF, 656 KB

english, 1987

43

Modified-Release Dosage Forms: Acceptance Criteria and Statistics for Bioequivalence

Hauschke, D., Steinijans, V. W.

Journal:

Drug Information Journal

Year:

1993

Language:

english

File:

PDF, 441 KB

english, 1993

44

Quantitative Bestimmung der Nierenfunktion In der Computertomographie

Klose, K. J., Walz, P. H., Steinijans, V.

Journal:

Biomedical Engineering/ Biomedizinische Technik

Year:

1984

Language:

german

File:

PDF, 351 KB

german, 1984

45

International Harmonization of Regulatory Requirements for Average Bioequivalence and Current Issues in Individual Bioequivalence

Steinijans, V. W., Hauschke, D., Schall, R.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

1995

Language:

english

File:

PDF, 588 KB

english, 1995

46

Choice of student's t-or wilcoxon-based confidence intervals for assessment of average bioequivalence

Hauck, Walter W, Hauschke, Dieter, Diletti, Edgar, Bois, Frédéric Y, Steinijans, Volker W, Anderson, Sharon

Journal:

Journal of Biopharmaceutical Statistics

Year:

1997

Language:

english

File:

PDF, 481 KB

english, 1997

47

A Dose-dependent Effect of the Novel Inhaled Corticosteroid Ciclesonide on Airway Responsiveness to Adenosine-5 ′ -Monophosphate in Asthmatic Patients

TAYLOR, DAVID A., JENSEN, MARIANNE W., KANABAR, VARSHA, ENGELSTÄTTER, RENATE, STEINIJANS, VOLKER W., BARNES, PETER J., O'CONNOR, BRIAN J.

Journal:

American Journal of Respiratory and Critical Care Medicine

Year:

1999

Language:

english

File:

PDF, 84 KB

english, 1999

48

Individual bioequivalence—a european perspective

Steinijans, Volker W., Hauschke, Dieter

Journal:

Journal of Biopharmaceutical Statistics

Year:

1997

Language:

english

File:

PDF, 436 KB

english, 1997

49

Twenty-four Hour Lung Function in Adult Patients with Asthma: Chronoptimized Theophylline Therapy Once-daily Dosing in the Evening versus Conventional Twice-daily Dosing

D'Alonzo, Gilbert E., Smolensky, Michael H., Feldman, Stuart, Gianotti, Leslie A., Emerson, Marcia B., Staudinger, Heribert, Steinijans, Volker W.

Journal:

American Review of Respiratory Disease

Year:

1990

Language:

english

File:

PDF, 824 KB

english, 1990

50

Measurements of morning and evening airflow grossly underestimate the circadian variability of FEV1 and peak expiratory flow rate in asthma.

D'Alonzo, G E, Steinijans, V W, Keller, A

Journal:

American Journal of Respiratory and Critical Care Medicine

Year:

1995

Language:

english

File:

PDF, 371 KB

english, 1995

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