Critical Remarks on Reference-Scaled Average Bioequivalence H Schütz, D Labes, MJ Wolfsegger Journal of Pharmacy and Pharmaceutical Sciences 25, 285–296, 2022 | 4 | 2022 |
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 | 4 | 2021 |
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 | 3 | 2020 |
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 | 16 | 2019 |
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 | 19 | 2018 |
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 | 14 | 2017 |
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 | 25 | 2016 |
Two-stage designs in bioequivalence trials H Schütz European Journal of Clinical Pharmacology 71 (3), 271–281, 2015 | 17 | 2015 |
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 | 1 | 2015 |
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 | 3 | 2014 |
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 | 6 | 2014 |
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 | 7 | 2014 |
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 | 1 | 2014 |
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 | 16 | 2011 |
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 | 13 | 2009 |
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 | 13 | 2006 |
An extremely strange observation? H Schütz European Journal of Drug Metabolism and Pharmacokinetics 29 (1), 69–72, 2004 | 1 | 2004 |
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 | 1 | 1997 |