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Helmut Schütz
Helmut Schütz
BEBAC
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Title
Cited by
Year
Critical Remarks on Reference-Scaled Average Bioequivalence
H Schütz, D Labes, MJ Wolfsegger
Journal of Pharmacy and Pharmaceutical Sciences 25, 285–296, 2022
42022
An iterative method to protect the type I error rate in bioequivalence studies under two-stage adaptive 2×2 crossover designs
E Molins, D Labes, H Schütz, E Cobo, J Ocaña
Biometrical Journal 63 (1), 122–133, 2021
42021
Assessing goodness‐of‐fit for evaluation of dose‐proportionality
MJ Wolfsegger, A Bauer, D Labes, H Schütz, R Vonk, B Lang, S Lehr, ...
Pharmaceutical Statistics 20 (2), 272–281, 2020
32020
Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits
H Schütz, D Labes, M Tomashevskiy, M González-de la Parra, A Shitova, ...
The AAPS Journal 22 (2), 44, 2020
2020
Sample size determination in bioequivalence studies using statistical assurance
A Ring, B Lang, C Kazaroho, D Labes, R Schall, H Schütz
British Journal of Clinical Pharmacology 85 (10), 2369–2377, 2019
162019
Pharmacokinetic modelling and validation of the half-life extension needed to reduce the burden of infusions compared with standard factor VIII
C Hermans, J Mahlangu, J Booth, H Schütz, E Santagostino, G Young, ...
Haemophilia 24 (3), 376–384, 2018
192018
Dissolution comparisons using a Multivariate Statistical Distance (MSD) test and a comparison of various approaches for calculating the measurements of dissolution profile …
JM Cardot, B Roudier, H Schütz
The AAPS Journal 19 (4), 1091–1101, 2017
142017
Inflation of Type I Error in the Evaluation of Scaled Average Bioequivalence, and a Method for its Control
D Labes, H Schütz
Pharmaceutical Research 33 (11), 2805–2814, 2016
252016
Two-stage designs in bioequivalence trials
H Schütz
European Journal of Clinical Pharmacology 71 (3), 271–281, 2015
172015
Adaptive two-stage bioequivalence trials with early stopping and sample size re-estimation
F König, M Wolfsegger, T Jaki, H Schütz, G Wasmer
Trials 16 (Suppl 2), P218, 2015
12015
Reference Datasets for Bioequivalence Trials in a Two-Group Parallel Design
A Fuglsang, H Schütz, D Labes
The AAPS Journal 17 (2), 400–404, 2014
32014
Impact of Data Base Structure in a Successful In Vitro-In Vivo Correlation for Pharmaceutical Products
B Roudier, B Davit, H Schütz, JM Cardot
The AAPS Journal 17 (1), 24–34, 2014
62014
Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies
H Schütz, D Labes, A Fuglsang
The AAPS Journal 16 (6), 1292–1297, 2014
72014
Adaptive two-stage bioequivalence trials with early stopping and sample size re-estimation
F König, M Wolfsegger, T Jaki, H Schütz, G Wasmer
35th Annual Conference of the International Society for Clinical …, 2014
12014
Performing Reference-Scaled Average Bioequivalence (RSABE) in Phoenix WinNonlin
A Henry, H Schütz, L Hughes, S Davis
AAPS Annual Meeting and Exposition, San Antonio, TX, 2013
2013
Quantitative determination of methylphenidate in plasma by gas chromatography negative ion chemical ionisation mass spectrometry using o-(pentafluorobenzyloxycarbonyl)-benzoyl …
HJ Leis, H Schütz, W Windischhofer
Analytical and Bioanalytical Chemistry 400 (8), 2663–2670, 2011
162011
Lack of bioequivalence between two methylphenidate extended modified release formulations in healthy volunteers
H Schütz, R Fischer, M Großmann, D Mazur, HJ Leis, R Ammer
International Journal of Clinical Pharmacology and Therapeutics 47 (12), 761–769, 2009
132009
Bioequivalence of a methylphenidate hydrochloride extended-release preparation: comparison of an intact capsule and an opened capsule sprinkled on applesauce
R Fischer, H Schütz, M Großmann, HJ Leis, R Ammer
International Journal of Clinical Pharmacology and Therapeutics 44 (3), 135–141, 2006
132006
An extremely strange observation?
H Schütz
European Journal of Drug Metabolism and Pharmacokinetics 29 (1), 69–72, 2004
12004
Relative bioavailability of 3 different chlormezanone 200 mg preparations after single dose oral administration
H Schütz, A Eichinger, V Nitsche, R Hofmann
International Journal of Clinical Pharmacology and Therapeutics 35 (3), 112–116, 1997
11997
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