Zobrazeno 1 - 10
of 22
pro vyhledávání: '"Lena Klopp-Schulze"'
Autor:
Hong Lu, Lena Klopp‐Schulze, Jatinder Kaur Mukker, Dandan Li, Yoshihiro Kuroki, Jayaprakasam Bolleddula, Nadia Terranova, Kosalaram Goteti, Wei Gao, Rainer Strotmann, Jennifer Dong, Karthik Venkatakrishnan
Publikováno v:
Clinical and Translational Science, Vol 17, Iss 10, Pp n/a-n/a (2024)
Abstract With the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guidelines in effect from 2018, the design of Asia‐inclusive multiregional clinical trials (MRCTs) has been streamline
Externí odkaz:
https://doaj.org/article/d5d8471bf06f4dc8acdf94e4a0ea1d08
Autor:
Kosalaram Goteti, Ramon Garcia, William R. Gillespie, Jonathan French, Lena Klopp‐Schulze, Ying Li, Cristina Vazquez Mateo, Sanjeev Roy, Oliver Guenther, Lisa Benincosa, Karthik Venkatakrishnan
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 2, Pp 281-295 (2024)
Abstract Several investigational agents are under evaluation in systemic lupus erythematosus (SLE) clinical trials but quantitative frameworks to enable comparison of their efficacy to reference benchmark treatments are lacking. To benchmark SLE trea
Externí odkaz:
https://doaj.org/article/7bef3d63ff144d048d023a316148b601
Autor:
John E. McKinnon, Joel Santiaguel, Claudia Murta de Oliveira, Dongzi Yu, Mukhy Khursheed, Flavie Moreau, Lena Klopp‐Schulze, Jamie Shaw, Sanjeev Roy, Amy H. Kao, the ANEMONE Study Team
Publikováno v:
Clinical and Translational Science, Vol 16, Iss 12, Pp 2640-2653 (2023)
Abstract Enpatoran is a selective inhibitor of toll‐like receptors 7 and 8 (TLR7/8) that potentially targets pro‐inflammatory pathways induced by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2). A phase II study conducted in Braz
Externí odkaz:
https://doaj.org/article/dac7d19bf3f140e78fae2fdc00bbf872
Autor:
Andreas Port, Jamie V. Shaw, Lena Klopp‐Schulze, Afrim Bytyqi, Claudia Vetter, Elizabeth Hussey, Nadra Mammasse, Victor Ona, Angelika Bachmann, Denis Strugala, Christian Reh, Kosalaram Goteti
Publikováno v:
Pharmacology Research & Perspectives, Vol 9, Iss 5, Pp n/a-n/a (2021)
Abstract This study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple oral doses of enpatoran (formerly named M5049), a new toll‐like receptor (TLR) 7 and 8 dual antagonist, and the effect o
Externí odkaz:
https://doaj.org/article/8b6bac10490c420498e14c91c2474382
Autor:
Lena Klopp-Schulze, Anna Mueller-Schoell, Patrick Neven, Stijn L. W. Koolen, Ron H. J. Mathijssen, Markus Joerger, Charlotte Kloft
Publikováno v:
Frontiers in Pharmacology, Vol 11 (2020)
IntroductionAt tamoxifen standard dosing, ∼20% of breast cancer patients do not reach proposed target endoxifen concentrations >5.97 ng/mL. Thus, better understanding the large interindividual variability in tamoxifen pharmacokinetics (PK) is cruci
Externí odkaz:
https://doaj.org/article/fc06d67b045e49eda67a9c6c4d9ed78f
Autor:
Anna Mueller-Schoell, Lena Klopp-Schulze, Robin Michelet, Madelé van Dyk, Thomas E. Mürdter, Matthias Schwab, Markus Joerger, Wilhelm Huisinga, Gerd Mikus, Charlotte Kloft
Publikováno v:
Pharmaceuticals, Vol 14, Iss 2, p 115 (2021)
Tamoxifen is widely used in breast cancer treatment and minimum steady-state concentrations of its active metabolite endoxifen (CSS,min ENDX) above 5.97 ng/mL have been associated with favourable disease outcome. Yet, about 20% of patients do not rea
Externí odkaz:
https://doaj.org/article/2c22f6de0b6c42f6b68afc845c3dd2b6
Autor:
Lena, Klopp-Schulze, Jamie V, Shaw, Jennifer Q, Dong, Akash, Khandelwal, Cristina, Vazquez-Mateo, Kosalaram, Goteti
Publikováno v:
Clinical Pharmacology & Therapeutics. 112:297-306
Dual toll-like receptor (TLR) 7 and TLR8 inhibitor enpatoran is under investigation as a treatment for lupus and coronavirus disease 2019 (COVID-19) pneumonia. Population pharmacokinetic/pharmacodynamic (PopPK/PD) model-based simulations, using PK an
Autor:
Ellen Copson, Hiltrud Brauch, Robin Michelet, Matthias Schwab, Wilhelm Huisinga, Lena Klopp-Schulze, Patrick Neven, Diana Eccles, Nathalie K. Zgheib, Thomas E. Mürdter, Sylvia Chen, Ron H.J. Mathijssen, Werner Schroth, Arafat Tfayli, Markus Joerger, Balram Chowbay, Anna Mueller-Schoell, Charlotte Kloft, Stijn L.W. Koolen
Publikováno v:
Clinical Pharmacology & Therapeutics, 108(3), 661-670. Wiley-Blackwell
Endoxifen is one of the most important metabolites of the prodrug tamoxifen. High interindividual variability in endoxifen steady-state concentrations (CSS,min ENDX ) is observed under tamoxifen standard dosing and patients with breast cancer who do
Autor:
Afrim Bytyqi, Denis Strugala, Lena Klopp‐Schulze, Victor Ona, Elizabeth Hussey, Jamie V. Shaw, Andreas Port, Kosalaram Goteti, Christian Reh, Nadra Mammasse, Angelika Bachmann, Claudia Vetter
Publikováno v:
Pharmacology Research & Perspectives, Vol 9, Iss 5, Pp n/a-n/a (2021)
Pharmacology Research & Perspectives
Pharmacology Research & Perspectives
This study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple oral doses of enpatoran (formerly named M5049), a new toll‐like receptor (TLR) 7 and 8 dual antagonist, and the effect of food on
Autor:
Lena Klopp-Schulze, Jamie Shaw, Jennifer Dong, Akash Khandelwal, Elizabeth Adams, Dongzi Yu, Kosalaram Goteti
Publikováno v:
Open Forum Infectious Diseases
Background Enpatoran, formerly known as M5049, is a potential first-in-class small molecule antagonist of toll-like receptors (TLR) 7 and 8, which may prevent viral-associated hyperinflammatory response and progression to ‘cytokine storm’ in coro