The New S7B/E14 Question and Answer Draft Guidance for Industry: Contents and Commentary

por Darpo, Borje, Ferber, Georg
Publicado 2021

Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study of the Effects of Omadacycline on QT/QTc Intervals in Healthy Subjects

por Darpo, Borje, Xue, Hongqi, Tanaka, S. Ken, Tzanis, Evan
Publicado 2019

A Phase I, Randomized, Double-Blinded, Placebo- and Moxifloxacin-Controlled, Four-Period Crossover Study To Evaluate the Effect of Gepotidacin on Cardiac Conduction as Assessed by...

por Hossain, Mohammad, Zhou, Meijian, Tiffany, Courtney, Dumont, Etienne, Darpo, Borje
Publicado 2017

Thorough QT/QTc Evaluation of the Cardiac Safety of Secnidazole at Therapeutic and Supratherapeutic Doses in Healthy Individuals

por Darpo, Borje, Xue, Hongqi, Adetoro, Nikki, Matthews, Barbara G., Pentikis, Helen S.
Publicado 2017

Potential strategy for assessing QT/QTc interval for drugs that produce rapid changes in heart rate: Electrocardiographic assessment of the effects of intravenous remimazolam on ca...

por Kleiman, Robert B., Darpo, Borje, Thorn, Michael, Stoehr, Thomas, Schippers, Frank
Publicado 2020

684. Cardiac Safety in Adults with Community-Acquired Bacterial Pneumonia (CABP) Treated with Lefamulin (LEF) or Moxifloxacin (MOX): Analysis of Lefamulin Evaluation Against Pneumo...

por Darpo, Borje, Das, Anita F, Stein, Daniel, Schranz, Jennifer, Gelone, Steven P
Publicado 2019

Effects of intranasal kinetic oscillation stimulation on heart rate variability

por Jerling, Markus, Cygankiewicz, Iwona, Al‐Tawil, Nabil, Darpo, Borje, Ljungström, Anders, Zareba, Wojciech
Publicado 2017

Diurnal QT analysis in patients with sotalol after cardioversion of atrial fibrillation

por Lenhoff, Hanna, Darpö, Börje, Page, Alex, Couderc, Jean Philippe, Tornvall, Per, Frick, Mats
Publicado 2021

Evaluation of the QT effect of a combination of piperaquine and a novel anti-malarial drug candidate OZ439, for the treatment of uncomplicated malaria

por Darpo, Borje, Ferber, Georg, Siegl, Peter, Laurijssens, Bart, Macintyre, Fiona, Toovey, Stephen, Duparc, Stephan
Publicado 2015

Revefenacin, a Long‐Acting Muscarinic Antagonist, Does Not Prolong QT Interval in Healthy Subjects: Results of a Placebo‐ and Positive‐Controlled Thorough QT Study

por Borin, Marie T., Barnes, Chris N., Darpo, Borje, Pendyala, Srikanth, Xue, Hongqi, Bourdet, David L.
Publicado 2019

The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects

por Mueller, Markus S., Sidharta, Patricia N., Voors-Pette, Christine, Darpo, Borje, Xue, Hongqi, Dingemanse, Jasper
Publicado 2020

Albiglutide Does Not Prolong QTc Interval in Healthy Subjects: A Thorough ECG Study

por Darpo, Borje, Zhou, Meijian, Matthews, Jessica, Zhi, Hui, Young, Malcolm A., Perry, Caroline, Reinhardt, Rickey R.
Publicado 2014

Erratum to: Albiglutide Does Not Prolong QTc Interval in Healthy Subjects: A Thorough ECG Study

por Darpo, Borje, Zhou, Meijian, Matthews, Jessica, Zhi, Hui, Young, Malcolm A., Perry, Caroline, Reinhardt, Rickey R.
Publicado 2014

A thorough QT study in the context of an uptitration regimen with selexipag, a selective oral prostacyclin receptor agonist

por Hoch, Matthias, Darpo, Borje, Remenova, Tatiana, Stoltz, Randall, Zhou, Meijian, Kaufmann, Priska, Bruderer, Shirin, Dingemanse, Jasper
Publicado 2014

Safety, Pharmacokinetics, and Pharmacodynamics of Trazpiroben (TAK‐906), a Novel Selective D(2)/D(3) Receptor Antagonist: A Phase 1 Randomized, Placebo‐Controlled Single‐ and Multi...

por Whiting, Roger L., Darpo, Borje, Chen, Chunlin, Fletcher, Margaret, Combs, Dan, Xue, Hongqi, Stoltz, Randall R.
Publicado 2021

Evaluation of Deutetrabenazine's Potential to Delay Cardiac Repolarization Using Concentration‐QTc Analysis

por Schneider, Frank, Darpo, Borje, Loupe, Pippa S., Xue, Hongqi, Knebel, Helena, Gutierrez, Maria, Gordon, Mark Forrest, Rabinovich‐Guilatt, Laura
Publicado 2022

Pridopidine Does Not Significantly Prolong the QTc Interval at the Clinically Relevant Therapeutic Dose

por Darpo, Borje, Geva, Michal, Ferber, Georg, Goldberg, Yigal Paul, Cruz-Herranz, Andres, Mehra, Munish, Kovacs, Richard, Hayden, Michael R.
Publicado 2023

Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECG

por Kleiman, Robert, Darpo, Borje, Brown, Randy, Rudo, Todd, Chamoun, Svetlana, Albert, David E., Bos, Johan Martijn, Ackerman, Michael J.
Publicado 2021

No QTc Prolongation With Zanubrutinib: Results of Concentration‐QTc Analysis From a Thorough QT Study in Healthy Subjects

por Mu, Song, Darpo, Borje, Tang, Zhiyu, Novotny, William, Tawashi, Manal, Xue, Hongqi, Willett, Michael, Lin, Leo, Sahasranaman, Sri, Ou, Ying C.
Publicado 2020

Exenatide at therapeutic and supratherapeutic concentrations does not prolong the QT(c) interval in healthy subjects

por Darpö, Börje, Sager, Philip, MacConell, Leigh, Cirincione, Brenda, Mitchell, Malcolm, Han, Jenny, Huang, Wenying, Malloy, Jaret, Schulteis, Christine, Shen, Larry, Porter, Lisa
Publicado 2013