Results 231 to 240 of about 806,722 (306)

A descriptive research: Exclusion from submitted clinical data package in the review process of new drug approval due to GCP violation in Japan. [PDF]

Contemp Clin Trials Commun, 2019
Asada R, Yoshimura K, Hattori K, Nonaka Y, Kasai H, Shimizu S.   +5 more
europepmc   +1 more source

Progress and Trends for Cancer Drug Approval – an Analysis of FDA Advisory Committee

, 2012
J.K. Chan, Idoroenyi Amanam, T. Kiet, N. Young‐Lin, Daniel F. Hoth, Daniel S. Kapp, B.J. Monk   +6 more
openalex   +1 more source

Association of the ICH Score With Withdrawal of Life‐Sustaining Treatment Over a 10‐Year Period

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective The intracerebral hemorrhage (ICH) score was developed to enhance provider communication and facilitate early severity assessment. We examined the association of the ICH score with mortality and withdrawal of life‐sustaining treatment (WLST) in a large, multicenter stroke registry, and evaluated temporal trends in these associations.
Nina Massad, Lili Zhou, Brian Manolovitz, Negar Asdaghi, Hannah Gardener, Hao Ying, Carolina M. Gutierrez, Angus Jameson, David Rose, Mohan Kottapally, Amedeo Merenda, Kristine O'Phelan, Sebastian Koch, Jose G. Romano, Tatjana Rundek, Ayham Alkhachroum   +15 more
wiley   +1 more source

Digital Activity Markers in Chronic Inflammatory Demyelinating Polyneuropathy

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective To evaluate the utility of smartwatch and smartphone‐based activity metrics for assessing disease severity and quality of life in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Methods In the electronic monitoring of disease activity in patients with CIDP (EMDA‐CIDP) trial, we performed a prospective ...
Lars Masanneck, Jan Voth, Noëmi Gmahl, Konstantin Jendretzky, Niklas Huntemann, Noah M. Werner, Linea Schmidt, Menekse Oeztuerk, Paula Quint, Christina B. Schroeter, Hans Peter Hartung, Thomas Skripuletz, Gerd Meyer zu Hörste, Tobias Ruck, Sven G. Meuth, Marc Pawlitzki   +15 more
wiley   +1 more source

Real World Data and Evidence: Support for Drug Approval: Applications to Kidney Diseases.

Clin J Am Soc Nephrol, 2019
Thompson AM, Southworth MR.
europepmc   +1 more source

Fast-track drug approval in inflammatory bowel diseases. [PDF]

Ann Gastroenterol, 2016
Katsanos KH, Koutroumpakis E, Giagkou E, Malakos Z, Almpani E, Skamnelos A, Christodoulou DK.   +6 more
europepmc   +1 more source

Comparative Effect of Standard Versus Extended Interval Dosing of Rituximab or Ocrelizumab in Multiple Sclerosis

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective We aimed to investigate the comparative effectiveness of standard versus personalized extended interval dosing of anti‐CD20 therapy on clinical and sub‐clinical outcomes in multiple sclerosis. Methods Clinical information was collected prospectively on Research Electronic Data Capture.
Nabil K. El Ayoubi, Fares Fahd, Hani Tamim, Salem Hannoun, Mark Bal, Elham El‐Hallak, Samia J. Khoury   +6 more
wiley   +1 more source

Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval. [PDF]

PLoS One, 2016
Kesselheim AS, Eddings W, Raj T, Campbell EG, Franklin JM, Ross KM, Fulchino LA, Avorn J, Gagne JJ.   +8 more
europepmc   +1 more source

U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia

, 2013
Firoozeh Alvandi, Virginia E. Kwitkowski, Chia‐Wen Ko, Mark D. Rothmann, Stacey Ricci, Haleh Saber, Debasis Ghosh, Janice Brown, Erika A. Pfeiler, Elsbeth G. Chikhale, Joseph A. Grillo, Julie Bullock, Robert C. Kane, Edvardas Kaminskas, Ann T. Farrell, Richard Pazdur   +15 more
openalex   +1 more source

Cognitive Resilience in Apolipoprotein ε4 Carrier Women Predicted by Neuron‐Derived Extracellular Vesicles

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective The Apolipoprotein (APOE) ε4 allele is the strongest genetic risk factor for late‐onset Alzheimer's disease (AD); however, many ε4 carriers remain cognitively intact into old age. Leveraging plasma neuron‐derived extracellular vesicles (NDEVs), we sought to identify biomarkers of cognitive resilience and their interplay with APOE ...
Apostolos Manolopoulos, Maja Mustapic, Carlos Nogueras‐Ortiz, Francheska Delgado‐Peraza, Krishna A. Pucha, Pamela J. Yao, Joseph Blommer, Michael P. Vreones, William York, De' Larrian Knight, Stephen R. Rapp, Aladdin H. Shadyab, JoAnn E. Manson, Ramon Casanova, Robert B. Wallace, Luigi Ferrucci, Susan M. Resnick, Dimitrios Kapogiannis   +17 more
wiley   +1 more source