CLINICAL EVALUATION OF VASCORAY
- Innovation! Vaughan, Roger D. // American Journal of Public Health;Aug2008, Vol. 98 Issue 8, p1353
The article discusses various reports published within the issue, including one fractional factorial experimental designs and another on the design of more-efficient, longer-term randomized controlled trials and other data management and statistical techniques to help detect adverse drug events...
- Underrecognition of adverse effects. Kuritzky, Louis // Alternative Medicine Alert;Aug2010 Supplement, p15
The article discusses research by M. Zimmerman published in the "Journal of Clinical Psychiatry" which investigated why adverse effects related to medication are usually undetected in clinical trials.
- Identification of adverse reactions to new drugs. IV--Verification of suspected adverse reactions. Venning, Geoffrey R. // British Medical Journal (Clinical Research Edition);2/12/1983, Vol. 286 Issue 6364, p544
Examines the verification of suspected adverse reactions through the identification of adverse reactions to drugs in Great Britain. Characteristics of different methods of verification; Importance on the design of clinical trials of drugs; Assessment of the voluntary reporting systems.
- Which AEs to collect for supplemental indications? // Reactions Weekly;12/11/2010, Issue 1331, p3
The article discusses research being done on the gathering of adverse event (AE) data in cancer clinical trials, which references a study by L. D. Kaiser and colleagues in the October 4, 2010 issue of the "Journal of Clinical Oncology."
- Pharmacovigilance & Regulatory News. // Reactions Weekly;5/28/2011, Issue 1353, p2
The article reports on the draft guidance released by the Indian Central Drugs Standard Control Organization (CDSCO) in May 2011 geared toward the tightening of requirements for the reporting of serious adverse events occurring during clinical trials.
- Lacosamide Doty, Pamela; Rudd, G. David; Stoehr, Thomas; Thomas, Dirk // Neurotherapeutics;Jan2007, Vol. 4 Issue 1, p145
Summary: Lacosamide is a new chemical entity being investigated as an adjunctive treatment for epilepsy, as well as monotherapy for diabetic neuropathic pain. Lacosamide appears to have a dual mode of action: selective enhancement of sodium channel inactivation and modulation of collapsin...
- Dobutamine. // Reactions Weekly;5/14/2011, Issue 1351, p21
The article describes the case of a 53-year-old woman who developed reversible cerebral vasoconstriction syndrome after receiving a dobutamine injection for stress testing.
- Novel dry AMD treatment found safe, tolerable in phase 1b study. // Ocular Surgery News;6/25/2012, Vol. 30 Issue 12, Special section p12
The article reports that according to a research involving phase 1b study by Ryo Kubota and colleagues, visual cycle modulator, is a safe and well-tolerated treatment for an oral dry age-related macular degeneration (AMD). It highlights that any ocular adverse events occurring during the...
- GHTF drafts doc on trial adverse event reports. McCarty, Mark // Medical Device Daily;8/14/2012, Vol. 16 Issue 157, p8
The article reports on the draft document produced by the Global Harmonization Task Force (GHTF) that addresses reporting requirements for adverse events incurred during clinical trials under ISO 14155.