Population pharmacokinetic-pharmacodynamic model of elinzanetant based on integrated clinical phase I and II data.

Autor: Willmann S; Bayer AG, Pharmaceuticals, Pharmacometrics/Modeling and Simulation, Wuppertal/Leverkusen/Berlin, Germany., Lloyd A; BAST Inc. Limited, Leicester, UK., Austin R; BAST Inc. Limited, Leicester, UK., Joseph S; BAST Inc. Limited, Leicester, UK., Solms A; Bayer AG, Pharmaceuticals, Pharmacometrics/Modeling and Simulation, Wuppertal/Leverkusen/Berlin, Germany., Zhang Y; Bayer AG, Pharmaceuticals, Pharmacometrics/Modeling and Simulation, Wuppertal/Leverkusen/Berlin, Germany., Schneider ARP; Bayer AG, Pharmaceuticals, Pharmacometrics/Modeling and Simulation, Wuppertal/Leverkusen/Berlin, Germany., Frechen S; Bayer AG, Pharmaceuticals, Pharmacometrics/Modeling and Simulation, Wuppertal/Leverkusen/Berlin, Germany., Schultze-Mosgau MH; Bayer AG, Pharmaceuticals, Clinical Pharmacology, Berlin, Germany.

Publikováno v: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Sep 18. Date of Electronic Publication: 2024 Sep 18.

Mass Balance and Metabolic Pathways of Eliapixant, a P2X3 Receptor Antagonist, in Healthy Male Volunteers.

Autor: Reif S; Clinical Pharmacology, Bayer AG Research and Development, Pharmaceuticals, Müllerstraße 178, 13353, Berlin, Germany. stefanie.reif@bayer.com., Schultze-Mosgau MH; Clinical Pharmacology, Bayer AG Research and Development, Pharmaceuticals, Müllerstraße 178, 13353, Berlin, Germany., Engelen A; Bayer AG Research and Development, Pharmaceuticals, Wuppertal, Germany., Piel I; Bayer AG Research and Development, Pharmaceuticals, Wuppertal, Germany., Denner K; Clinical Pharmacology, Bayer AG Research and Development, Pharmaceuticals, Müllerstraße 178, 13353, Berlin, Germany., Roffel A; ICON Plc (Formerly PRA Health Sciences), Van Swietenlaan 6, 9728 NZ, Groningen, The Netherlands., Tiessen R; ICON Plc (Formerly PRA Health Sciences), Van Swietenlaan 6, 9728 NZ, Groningen, The Netherlands., Klein S; Clinical Pharmacology, Bayer AG Research and Development, Pharmaceuticals, Müllerstraße 178, 13353, Berlin, Germany., Francke K; Clinical Pharmacology, Bayer AG Research and Development, Pharmaceuticals, Müllerstraße 178, 13353, Berlin, Germany., Rottmann A; Clinical Pharmacology, Bayer AG Research and Development, Pharmaceuticals, Müllerstraße 178, 13353, Berlin, Germany.

Publikováno v: European journal of drug metabolism and pharmacokinetics [Eur J Drug Metab Pharmacokinet] 2024 Jan; Vol. 49 (1), pp. 71-85. Date of Electronic Publication: 2023 Dec 03.

Single- and Multiple-Dose Pharmacokinetics and Safety of Vilaprisan in Healthy Postmenopausal Japanese Women: A Randomized Clinical Trial.

Autor: Schultze-Mosgau MH; Clinical Pharmacology, Bayer AG, 13342, Berlin, Germany. marcus.schultze-mosgau@bayer.com., Matsuki S; Fukuoka Mirai Hospital, Fukuoka, Japan.; Clinical Pharmacology, Bayer Yakuhin Ltd., Osaka, Japan., Okumura K; Clinical Pharmacology, Bayer Yakuhin Ltd., Osaka, Japan., Kaneko M; Clinical Pharmacology, Bayer Yakuhin Ltd., Osaka, Japan.

Publikováno v: European journal of drug metabolism and pharmacokinetics [Eur J Drug Metab Pharmacokinet] 2022 Jan; Vol. 47 (1), pp. 49-56. Date of Electronic Publication: 2021 Oct 11.

Effect of Food Intake on the Pharmacokinetics of the Selective Progesterone Receptor Modulator Vilaprisan: A Randomized Clinical Study in Healthy Postmenopausal Women.

Autor: Schultze-Mosgau MH; Bayer AG, Clinical Pharmacology, Berlin, Germany., Kaiser A; Bayer AG, Statistics & Data Insights, Berlin, Germany., Zollmann FS; Pharma Consult, Berlin, Germany.

Publikováno v: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Jun; Vol. 10 (6), pp. 675-680. Date of Electronic Publication: 2020 Oct 05.

The effects of vilaprisan on the pharmacodynamics and pharmacokinetics of a combined oral contraceptive-A randomized controlled trial.

Autor: Schultze-Mosgau MH; Department of Clinical Pharmacology, Research & Development, Pharmaceuticals, Bayer AG, Berlin, Germany., Schütt B; Department of Clinical Pharmacology, Research & Development, Pharmaceuticals, Bayer AG, Berlin, Germany., Draeger C; dinox GmbH, Female Health Research, Berlin, Germany., Casjens M; CRS Clinical Research Services Berlin GmbH, Berlin, Germany., Loewen S; Early Development Statistics, Chrestos Concept GmbH & Co. KG, Essen, Germany., Zimmermann T; Department of Clinical Pharmacology, Research & Development, Pharmaceuticals, Bayer AG, Berlin, Germany., Rohde B; Department of Clinical Pharmacology, Research & Development, Pharmaceuticals, Bayer AG, Berlin, Germany.

Publikováno v: British journal of clinical pharmacology [Br J Clin Pharmacol] 2021 Mar; Vol. 87 (3), pp. 925-936. Date of Electronic Publication: 2020 Jul 24.