Výsledky vyhledávání - "Mani Lakshminarayanan"

Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease (GRAVITAS-301) : a randomised, multicentre, double-blind, phase 3 trial

Autor: Robert Zeiser, Gérard Socié, Mark A Schroeder, Sunil Abhyankar, Carlos Pinho Vaz, Mi Kwon, Johannes Clausen, Leonid Volodin, Sebastian Giebel, Manuel Jurado Chacon, Gabrielle Meyers, Monalisa Ghosh, Dries Deeren, Jaime Sanz, Rodica Morariu-Zamfir, Michael Arbushites, Mani Lakshminarayanan, April M Barbour, Yi-Bin Chen

Publikováno v: LANCET HAEMATOLOGY
r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe
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Background Acute graft-versus-host disease (GVHD) is a common and life-threatening complication of allogeneic haematopoietic stem cell transplantation (HSCT); there is an urgent unmet need for effective therapies. We aimed to evaluate the Janus kinas

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::353d31983440702d66df5561eef6119c
https://fundanet.iislafe.san.gva.es/publicaciones/ProdCientif/PublicacionFrw.aspx?id=15756

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First-in-human, phase I study of PF-06647263, an anti-EFNA4 calicheamicin antibody-drug conjugate, in patients with advanced solid tumors

Autor: Erika Hamilton, Theresa L. Werner, Ignacio Garrido-Laguna, Christopher J. Zopf, Amy Weise, Ian E. Krop, Maysa M. Abu-Khalaf, Mani Lakshminarayanan, Steven Pirie-Shepherd, David S. Hong, Jaymes S. Holland, Raffaele Baffa, Fadi Braiteh, Howard A. Burris

Publikováno v: International Journal of Cancer. 145:1798-1808

PF-06647263, a novel antibody-drug conjugate consisting of an anti-EFNA4 antibody linked to a calicheamicin payload, has shown potent antitumor activity in human xenograft tumor models, including triple-negative breast cancer (TNBC). In the dose-esca

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::32d64a23ee601087b700c413f490d19a
https://doi.org/10.1002/ijc.32154

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Abstract CT236: A Two-Part Phase 2 Study of Itacitinib Immediate Release in Patients with Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy

Autor: Mani Lakshminarayanan, Lea Burke, Philomena Colucci, Andrew T. Kuykendall

Publikováno v: Cancer Research. 81:CT236-CT236

Background: Ruxolitinib (JAK1/JAK2 inhibitor) and fedratinib (JAK2/FLT3 inhibitor) are indicated in the US for myelofibrosis (MF); however, some patients fail to achieve adequate/sustained response to initial JAK-inhibitor therapy. Itacitinib is a po

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::4f9c93f13f5870266e2896b7eeeb7692
https://doi.org/10.1158/1538-7445.am2021-ct236

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Elektronická kniha

Bayesian Applications in Pharmaceutical Development

Autor: Mani Lakshminarayanan, Fanni Natanegara

The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached $2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative trial designs/ analys

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Bayesian probability of success for clinical trials using historical data

Autor: Joseph F. Heyse, Guanghan F. Liu, Ming-Hui Chen, Mani Lakshminarayanan, Joseph G. Ibrahim

Publikováno v: Statistics in Medicine. 34:249-264

Developing sophisticated statistical methods for go/no-go decisions is crucial for clinical trials, as planning phase III or phase IV trials is costly and time consuming. In this paper, we develop a novel Bayesian methodology for determining the prob

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::562f2f142d155a8100fd44f57b4178c0
https://doi.org/10.1002/sim.6339

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Bayesian Biostatistics, by Emmanuel Lesaffre and Andrew B. Lawson, John Wiley & Sons, 2012

Autor: Mani Lakshminarayanan

Publikováno v: Journal of Biopharmaceutical Statistics. 23:944-947

Evolution of Bayesian methods in real-life applications has come a long way. This is especially true regarding textbook material availability since the early days of Jim Berger's classic book on Th...

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e1965b7f56e066796c1fad5b0364ce5c
https://doi.org/10.1080/10543406.2013.789819

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