Iskalni niz:
išči po
išči po
išči po
išči po
Vrsta gradiva:
Jezik:
Št. zadetkov: 4
Differences between the 2016 and 2022 food and drug administration guidance
Jurij Hanžel, Christopher Ma, Laurent Peyrin-Biroulet, Silvio Danese, Bruce E Sands, Vipul Jairath
Izvirni znanstveni članek
Oznake: food guidance;drug guidence;differences;
Background: In 2022, the Food and Drug Administration (FDA) updated its draft guidance for drug development in ulcerative colitis, replacing the version from 2016. Several changes from the 2016 version merit further discussion as they impact clinical trial design and the interpretation of trial resu ...
Leto: 2024 Vir: Digitalni repozitorij raziskovalnih organizacij Slovenije
ǂAn ǂinternational consensus on the design of clinical trials for advanced combination treatment (ACT) in inflammatory bowel disease
Virginia Solitano, Jurij Hanžel, Christopher Ma, Robert Battat, Tim Raine, Britta Siegmund, Laurent Peyrin-Biroulet, Bram Verstockt, Joana Torres
Izvirni znanstveni članek
Oznake: Crohn's disease;ulcerative colitis;combination treatment;dual therapy;inflammatory bowel disease;
Background: Advanced Combination Treatment (ACT) refers to the dual use of two advanced therapies—either two biologics, two small molecules, or one biologic and one small molecule. There is a lack of guidance regarding clinical trial design for ACT in patients with inflammatory bowel disease (IBD). ...
Leto: 2025 Vir: Digitalni repozitorij raziskovalnih organizacij Slovenije
Placebo rates in randomised clinical trials of ulcerative colitis
Virginia Solitano, Malcolm Hogan, Siddharth Singh, Silvio Danese, Laurent Peyrin-Biroulet, Sudheer Kumar Vuyyuru, John K MacDonald, Guangyong Zou, Jurij Hanžel
Pregledni znanstveni članek
Oznake: inflammatory bowel disease;placebo effect;clinical trials;ulcerative colitis;
Background and aims: We assessed placebo rates and associated factors using individual patient data (IDP) from randomised clinical trials (RCTs) in ulcerative colitis (UC). Methods: We conducted an IPD meta-analysis using Vivli and Yale University Open Data Access data-sharing platforms. Phase 2 and ...
Leto: 2025 Vir: Digitalni repozitorij raziskovalnih organizacij Slovenije
Determining the optimal treatment target in patients with ulcerative colitis
Vipul Jairath, Guangyong Zou, Zhongya Wang, Shashi Adsul, Jean-Frederic Colombel, Geert R. D'Haens, Marcelo Freire, Gordon W. Moran, Laurent Peyrin-Biroulet, William J. Sandborn, Jurij Hanžel
Izvirni znanstveni članek
Oznake: ulcerative colitis;optimal treatment target;
Leto: 2024 Vir: Digitalni repozitorij raziskovalnih organizacij Slovenije
Št. zadetkov: 4
Ključne besede:
Leto izdaje:
Avtorji:
Repozitorij:
Tipologija:
Jezik: