Results 101 to 110 of about 5,545,002 (288)

Imbalance in glycemic control between the treatment and placebo groups in cardiovascular outcome trials in type 2 diabetes

open access: yesJournal of Pharmaceutical Policy and Practice, 2019
Background Glycated hemoglobin (HbA1c) is accepted as the most reliable marker for assessing chronic glycemia. The present study aimed to investigate glycemic control in cardiovascular outcome trials (CVOTs) performed by pharmaceutical sponsors, at the ...
Rumiko Shimazawa, Masayuki Ikeda
doaj   +1 more source

New drugs approval

open access: yesBangladesh Pharmaceutical Journal, 2015
Abstract not availableBangladesh Pharmaceutical Journal 18(1): 83-84 ...
openaire   +3 more sources

The US Food and Drug Administration’s expedited approval programs: addressing premarket flexibility with enhanced postmarket evidence generation [PDF]

open access: yes, 2018
When the editors of Clinical Trials solicited our review on the U.S. Food and Drug Administration’s (FDA) expedited development and review programs, we anticipated there would be accompanying commentaries from other academics with differing opinions, or ...
Naci, Huseyin   +2 more
core   +1 more source

Maximizing the Impact of Microphysiological Systems with in Vitro–in Vivo Translation [PDF]

open access: yes, 2018
Microphysiological systems (MPS) hold promise for improving therapeutic drug approval rates by providing more physiological, human-based, in vitro assays for preclinical drug development activities compared to traditional in vitro and animal models. Here,
Cirit, Murat, Stokes, Cynthia L.
core   +1 more source

Fluoroquinolones and tendon disorders [PDF]

open access: yes, 2001
Since the 'thalidomide disaster' in 1961, there is extensive national and intemationallegisiation for the registration and monitoring of drugs. The current drug approval process in most developed countries includes pre-clinical animal testing followed
Linden, P.D. (Paul) van der
core   +1 more source

Research of effectiveness and approval criteria for treatments with medications for patients with cancer: a review

open access: yesIatreia, 2018
Several malignant disorders of human tissues affect a large proportion of people in Colombia and worldwide, which has led to an increase in pharmacological treatments for these diseases, without the real benefit being clear to the patients who receive ...
Arango Vélez, Elkin Fernando   +7 more
doaj   +1 more source

Regulation with Placebo Effects [PDF]

open access: yes, 2008
A growing scientific literature supports the existence of placebo effects from a wide range of health interventions and for a range of medical conditions.
Malani, Anup
core   +1 more source

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