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At least 91 records · Page 5Linked to original sources
PubMed2006

The drug diagnostic co-development concept paper: commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop.

At the Washington DC Pharmacogenomics in Drug Development and Regulatory Decision-Making: Workshop III - Three Years of Promise, Proposals and Progress on Optimizing the Benefit/Risk of Medicines (11-13 April 2005), one break-out session (Track 2) focused on co-development of therapeutic drug and diagnostic products. The Food and Drug Administration (FDA) released a draft concept paper shortly before the workshop was to convene. Track 2 was a forum for initial discussion of the content of the concept paper, and industry's initial reactions. After the workshop, formal commentaries on the co-development concept paper were submitted by several trade associations (e.g., Pharmaceutical Research and Manufacturers of America (PhRMA), Advanced Medical Technology Association (AdvaMed), American Association for Clinical Chemistry) and individual companies to FDA's Docket No. 2004N-0279. This paper includes a summary of the key features of the draft concept paper, the discussion in Track 2 of the April, 2005 meeting and highlights of the industry comments submitted to the FDA docket following the meeting.

Clinical Trials as Topic↗
PubMed2000

Sonodynamically induced antitumor effect of 4-formyloximethylidene-3-hydroxy-2-vinyl-deuterio-porphynyl(IX)-6,7-dia spartic acid (ATX-S10).

The sonodynamically induced antitumor effect of 4-formyloximethylidene-3-hydroxy-2-vinyl-deuterio-porphyn yl(IX)-6,7-diaspartic acid (ATX-S10) was investigated. Both in vitro and in vivo antitumor effects were tested in combination with ultrasound at 2 MHz. The rate of ultrasonically induced damage to isolated sarcoma 180 cells in air-saturated suspension was enhanced two-fold with 80 microM ATX-S10. This enhancement was significantly inhibited by histidine, which may suggest that it was mediated by ultrasonically induced oxidation. The coadministraion of 25 mg/kg ATX-S10 followed by ultrasonic exposure at 2 MHz stopped the growth of implanted colon 26 tumors at an intensity at which ultrasound alone showed only a slight antitumor effect.

Animals↗
PubMed2000

DIAS I: duplex-sonographic assessment of the cerebrovascular status in acute stroke. A useful tool for future stroke trials.

BACKGROUND AND PURPOSE: A number of controlled trials have evaluated the benefit of intravenous thrombolysis in acute stroke with inconsistent results. None of these studies assessed the initial vascular status or provided information regarding the recanalization rate after therapy. Further trials need to clarify whether certain subgroups might possibly benefit more than others from intravenous thrombolysis. Therefore, a fast and valid method for assessment of cerebrovascular status is needed. In this multicenter study, we evaluated the potentials and limitations of color-coded duplex sonography (TCCS) for cerebrovascular status assessment in acute stroke patients before and after therapy. Furthermore, we compared the recanalization rate for patients referred to thrombolytic and conservative medical therapy. METHODS: Fifty-eight patients suffering from hemispheric stroke were enrolled consecutively in 8 centers. Duplex sonography was performed on admission, 2 hours after start of therapy, and 24 hours after onset of symptoms. Therapy was started within 6 hours. RESULTS: Intravenous thrombolysis was performed in 18 patients, conservative medical therapy in 39 patients, and early thromboendarterectomy in 1 patient. The middle cerebral artery (MCA) mainstem was patent in 29 patients (53.7%), occluded in 25 (46.3%), and was not assessable in 4 patients. Recanalization of the occluded MCA after 2 and 24 hours was diagnosed in 50% and 78% of the patients treated with rtPA and in 0% and 8% in the conservatively treated patients. CONCLUSIONS: Intravenous thrombolysis is highly effective in restoring blood flow after MCA occlusion. TCCS is suitable for assessment of the cerebrovascular status in acute stroke and therefore might define therapeutically relevant subgroups of patients in future stroke trials on the basis of their vascular pathology.

Adult↗
PubMed2003

The clinical significance of antibody screening test including Dia+ panel cell in Asian-Mongoloid populations.

The Di(a) antigen is well known as one of the antigens with low incidence among Caucasians; however, it has been discovered with a relatively higher incidence among Mongoloid populations. Thus, it has been speculated that the incidence of unexpected antibody against the Di(a) antigen might be relatively higher among these populations. Hemolytic transfusion reactions (HTRs) and hemolytic disease of the newborns (HDNs) caused by anti-Di(a) have been reported sporadically. However, there has been no prospective study on the incidence of anti-Di(a) in Mongoloid populations particularly. The authors conducted a series of antibody screening tests on 11,219 Korean individuals for 25 months, by using three kinds of screening cells including Di(a) cell. Anti-Di(a) was detected in 8 patients, seven of whom had a history of transfusions or were multigravida. The incidence of anti-Di(a) measured in this study was higher than expected, ranked third among unexpected antibodies identified during the period of the study, so it is strongly recommended that the Di(a+) panel cell must be incorporated into antibody screening test for safer transfusion in Asian-Mongoloid populations.

Adult↗