The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study

por Ferber, Georg, Lorch, Ulrike, Täubel, Jörg
Publicado 2015

Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity

por Ferber, Georg, Fernandes, Sara, Täubel, Jörg
Publicado 2017

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

por Lorch, Ulrike, O’Kane, Martin, Taubel, Jorg
Publicado 2014

Blinding Is Seeing: A Single-Centre Study Into the Viability of Auto-Injectors for Blinded-Drug Administration in Randomised Controlled Trials

por Aggarwal, Vishal, Taubel, Jorg, Lorch, Ulrike, York, Thomas
Publicado 2023

The Reliability of Auto-Injectors in Clinical Use: A Systematic Review

por Dostal, Petr, Taubel, Jorg, Lorch, Ulrike, Aggarwal, Vishal, York, Thomas
Publicado 2023

Safety, Tolerability, and Dose Proportionality of a Novel Transdermal Fentanyl Matrix Patch and Bioequivalence With a Matrix Fentanyl Patch: Two Phase 1 Single‐Center Open‐Label, R...

por Lorch, Ulrike, Pierscionek, Tomasz, Freier, Anne, Spencer, Christopher S., Täubel, Jörg
Publicado 2020

Pharmacokinetics, Safety and Cognitive Function Profile of Rupatadine 10, 20 and 40 mg in Healthy Japanese Subjects: A Randomised Placebo-Controlled Trial

por Täubel, Jörg, Ferber, Georg, Fernandes, Sara, Lorch, Ulrike, Santamaría, Eva, Izquierdo, Iñaki
Publicado 2016

Comparing the consistency of electrocardiogram interval measurements by resting ECG versus 12‐lead Holter

por Mendzelevski, Boaz, Spencer, Christopher S, Freier, Anne, Camilleri, Dorothée, Graff, Claus, Täubel, Jörg
Publicado 2021

Single Doses up to 800 mg of E-52862 Do Not Prolong the QTc Interval – A Retrospective Validation by Pharmacokinetic-Pharmacodynamic Modelling of Electrocardiography Data Utilising...

por Täubel, Jörg, Ferber, Georg, Lorch, Ulrike, Wang, Duolao, Sust, Mariano, Camm, A. John
Publicado 2015

Thorough QT study of the effect of intravenous amisulpride on QTc interval in Caucasian and Japanese healthy subjects

por Täubel, Jörg, Ferber, Georg, Fox, Gabriel, Fernandes, Sara, Lorch, Ulrike, Camm, A. John
Publicado 2016

Time- and Race-Specific Haematological Reference Intervals for Healthy Volunteer Trials: A Retrospective Analysis of Pooled Data From Multiple Phase I Trials

por Coates, Simon, Wang, Duolao, Pierscionek, Tomasz, Fernandes, Sara, Djumanov, Dilshat, Lorch, Ulrike, Täubel, Jörg
Publicado 2020

Pharmacodynamic Consequences of Administration of VLA-4 Antagonist CDP323 to Multiple Sclerosis Subjects: A Randomized, Double-Blind Phase 1/2 Study

por Wolf, Christian, Sidhu, Jagdev, Otoul, Christian, Morris, Dexter L., Cnops, Jennifer, Taubel, Jorg, Bennett, Barbara
Publicado 2013

Effect of hyperglycaemia in combination with moxifloxacin on cardiac repolarization in male and female patients with type I diabetes

por Taubel, Jorg, Pimenta, Dominic, Cole, Samuel Thomas, Graff, Claus, Kanters, Jørgen K., Camm, A. John
Publicado 2022

Kinetics of anti-SARS-CoV-2 IgG antibody levels and potential influential factors in subjects with COVID-19: A 11-month follow-up study

por Luo, Huanyuan, Camilleri, Dorothée, Garitaonandia, Ibon, Djumanov, Dilshat, Chen, Tao, Lorch, Ulrike, Täubel, Jörg, Wang, Duolao
Publicado 2021

Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges

por Mundy, Charles, Bush, James, Cheriyan, Joseph, Lorch, Ulrike, Stringer, Steffan, Taubel, Jörg, Wydenbach, Kirsty, Hardman, Timothy C.
Publicado 2023

Confirmation of the Cardiac Safety of PGF(2α) Receptor Antagonist OBE022 in a First‐in‐Human Study in Healthy Subjects, Using Intensive ECG Assessments

por Täubel, Jörg, Lorch, Ulrike, Coates, Simon, Fernandes, Sara, Foley, Paul, Ferber, Georg, Gotteland, Jean‐Pierre, Pohl, Oliver
Publicado 2018

Confirmation of the cardiac safety of nolasiban in a randomised cohort of healthy female volunteers

por Täubel, Jörg, Lorch, Ulrike, Spencer, Christopher S., Freier, Anne, Camilleri, Dorothée, Djumanov, Dilshat, Ferber, Georg, Marchand, Line, Gotteland, Jean-Pierre, Pohl, Oliver
Publicado 2021

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising TAK-438 (Vonoprazan) Doses in Healthy Male Japanese/non-Japanese Subjects

por Sakurai, Yuuichi, Nishimura, Akira, Kennedy, Gale, Hibberd, Mark, Jenkins, Richard, Okamoto, Hiroyuki, Yoneyama, Tomoki, Jenkins, Helen, Ashida, Kiyoshi, Irie, Shin, Täubel, Jörg
Publicado 2015

The Cardiovascular Effects of a Meal: J‐T(peak) and T(peak)‐T(end) Assessment and Further Insights Into the Physiological Effects

por Täubel, Jörg, Ferber, Georg, Van Langenhoven, Leen, del Bianco, Teresa, Fernandes, Sara, Djumanov, Dilshat, Kanters, Jørgen K., Graff, Claus, Camm, A. John
Publicado 2019

Results of a phase 1/2 study of cemdisiran in healthy subjects and patients with paroxysmal nocturnal hemoglobinuria

por Gaya, Anna, Munir, Talha, Urbano‐Ispizua, Alvaro, Griffin, Morag, Taubel, Jorg, Bush, Jim, Bhan, Ishir, Borodovsky, Anna, Wang, Yue, Badri, Prajakta, Garg, Pushkal
Publicado 2023