Zobrazeno 1 - 10
of 33
pro vyhledávání: '"Kosalaram, Goteti"'
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:
Asger Reinstrup Bihlet, Torben Balchen, Kosalaram Goteti, Jesper Sonne, Christoph Ladel, Morten Asser Karsdal, Victor Ona, Flavie Moreau, Roseann Waterhouse, Anne‐Christine Bay‐Jensen, Hans Guehring
Publikováno v:
ACR Open Rheumatology, Vol 6, Iss 4, Pp 205-213 (2024)
Objective To assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple injections of M6495, a disintegrin and metalloproteinase with thrombospondin motifs 5 (ADAMTS‐5) nanobody, in healthy volunteers and patients wi
Externí odkaz:
https://doaj.org/article/59a53152c87d4341ac5e68cc12a2ad20
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:
Kosalaram Goteti, Jonathan French, Ramon Garcia, Ying Li, Florence Casset‐Semanaz, Aida Aydemir, Robert Townsend, Cristina Vazquez Mateo, Matthew Studham, Oliver Guenther, Amy Kao, Marc Gastonguay, Pascal Girard, Lisa Benincosa, Karthik Venkatakrishnan
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 2, Pp 180-195 (2023)
Abstract Systemic lupus erythematosus (SLE) is an autoimmune disease affecting multiple organ systems. Many investigational agents have failed or shown only modest effects when added to standard of care (SoC) therapy in placebo‐controlled trials, a
Externí odkaz:
https://doaj.org/article/1557da4204d843a4921890da95fb3dbf
Autor:
Kristyn Pantoja, Shankar Lanke, Alain Munafo, Anja Victor, Christina Habermehl, Armin Schueler, Karthik Venkatakrishnan, Pascal Girard, Kosalaram Goteti
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 11, Iss 10, Pp 1371-1381 (2022)
Abstract One of the objectives of oncology phase I dose‐escalation studies has been to determine the maximum tolerated dose (MTD). Although MTD is no longer set as the dose for further development in contemporary oncology drug development, MTD dete
Externí odkaz:
https://doaj.org/article/ab6710d0c3df4e3eb9793d4ded39e1a8
Autor:
Sebastian Haertter, Jitendar Kanodia, Jack Cook, Jeanette Alicea, Bonnie J. Brennan, Amit Desai, Bela Patel, Lin Pan, Kosalaram Goteti
Publikováno v:
Clinical and Translational Science, Vol 15, Iss 3, Pp 601-609 (2022)
Abstract An IQ consortium working group (WG) conducted a survey across multiple biopharmaceutical companies to gain information about the level of blinding commonly utilized for early clinical development trials. The main objectives were: (1) to unde
Externí odkaz:
https://doaj.org/article/215f17ecb4f545a98aba5c405220611a
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:
Kosalaram Goteti, Jonathan French, Ramon Garcia, Ying Li, Florence Casset‐Semanaz, Aida Aydemir, Robert Townsend, Cristina Vazquez Mateo, Matthew Studham, Oliver Guenther, Amy Kao, Marc Gastonguay, Pascal Girard, Lisa Benincosa, Karthik Venkatakrishnan
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology. 12:180-195
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::17395fafa5e6187a99e1b713a51dd913
https://doi.org/10.1002/psp4.12888
https://doi.org/10.1002/psp4.12888
Opportunities and Challenges of Disease Progression Modeling in Drug Development – An IQ Perspective
Autor:
Kosalaram Goteti, Nathan Hanan, Mindy Magee, Jessica Wojciechowski, Sven Mensing, Bojan Lalovic, Yaming Hang, Alexander Solms, Indrajeet Singh, Rajendra Singh, Theodore Robert Rieger, Jin Y. Jin
Publikováno v:
Clinical Pharmacology & Therapeutics.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::92c4fe36279f7288ae2513468645d195
https://doi.org/10.1002/cpt.2873
https://doi.org/10.1002/cpt.2873
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e2d89bc37fec6cb6e33501a975b5d55f
https://doi.org/10.1002/cpt.2606
https://doi.org/10.1002/cpt.2606