Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 2 de 2
Filter
Add more filters










Database
Language
Publication year range
1.
Regul Toxicol Pharmacol ; 55(3): 276-80, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19607869

ABSTRACT

The evaluation of the quality of data and their use within the review of environmental risk assessment of human as well as veterinary pharmaceuticals is described from a regulatory point of view. A definition and differentiation in three categories for the reliability of data are given. Existing criteria relating to international testing standards for categorising reliability are adopted for their use within the environmental risk assessment of pharmaceuticals. A systematic documentation of evaluating reliability for literature data as well as for experimental studies (effect and environmental fate studies) is proposed. The data quality criteria are defined in order to increase the transparency of the evaluation process in Germany and thus the quality of the environmental risk assessment of pharmaceuticals.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Environmental Exposure/legislation & jurisprudence , Environmental Monitoring/legislation & jurisprudence , Veterinary Drugs/toxicity , Animals , Environmental Exposure/adverse effects , Environmental Monitoring/methods , Germany , Guidelines as Topic , Humans , Reproducibility of Results , Risk Assessment/legislation & jurisprudence , Risk Assessment/methods
2.
Am Heart J ; 149(1): 13-9, 2005 Jan.
Article in English | MEDLINE | ID: mdl-15660030

ABSTRACT

BACKGROUND: Patients with diabetes have an increased incidence and severity of ischemic heart disease, which leads to an increased requirement for coronary revascularization. Comparative information regarding mode of revascularization--coronary artery bypass graft surgery surgery (CABG) or percutaneous coronary intervention (PCI)--is limited, mainly confined to a subanalysis of the Bypass Angioplasty Revascularization (BARI) trial, suggesting a mortality benefit of CABG over PCI. No prospective trial has specifically compared these modes of revascularization in patients with diabetes. OBJECTIVE: The Coronary Artery Revascularisation in Diabetes (CARDia) trial is designed to address the hypothesis that optimal PCI is not inferior to modern CABG as a revascularization strategy for diabetics with multivessel or complex single-vessel coronary disease. The primary end point is a composite of death, nonfatal myocardial infarction, and cerebrovascular accident at 1 year. METHOD: A total of 600 patients with diabetes are to be randomized to either PCI or CABG, with few protocol restrictions on operative techniques or use of new technology. This gives a power of 80% to detect non-inferiority of PCI assuming that the PCI 1-year event rate is 9%. A cardiac surgeon and a cardiologist must agree that a patient is suitable for revascularization by either technique prior to recruitment into the study. Twenty-one centers in the United Kingdom and Ireland are recruiting patients. Data on cost effectiveness, quality of life, and neurocognitive function are being collected. Long-term (3-5 year) follow-up data will also be collected.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Artery Bypass , Coronary Disease/therapy , Diabetes Complications , Coronary Disease/complications , Coronary Disease/surgery , Humans , Immunosuppressive Agents/administration & dosage , Multicenter Studies as Topic , Myocardial Infarction , Randomized Controlled Trials as Topic , Research Design , Sirolimus/administration & dosage , Stents
SELECTION OF CITATIONS
SEARCH DETAIL
...