Lopid Patent Term Restoration and Fairness Act of 1987: Hearing Before the Subcommittee on Courts, Civil Liberties, and the Administration of Justice of the Committee on the Judiciary, House of Representatives, One Hundredth Congress, First Session, October 8, 1987, Volume 4U.S. Government Printing Office, 1988 - 350 pages |
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Page 70
... progression precluded this . Thus Gemfibrozil was reviewed and approved in an atmosphere now gone . It was only approved with a requirement for a Phase IV study that has cost millions of dollars , a study that would not be asked for ...
... progression precluded this . Thus Gemfibrozil was reviewed and approved in an atmosphere now gone . It was only approved with a requirement for a Phase IV study that has cost millions of dollars , a study that would not be asked for ...
Page 114
... progression of atherosclerotic vascular disease . Lipid - lowering diets and drugs which decrease LDL - cholesterol have both been used in an attempt to prevent the development of arterial disease , but neither has proved to be ...
... progression of atherosclerotic vascular disease . Lipid - lowering diets and drugs which decrease LDL - cholesterol have both been used in an attempt to prevent the development of arterial disease , but neither has proved to be ...
Page 118
... progression of ischaemic heart disease . In addition , the ratio of HDL- cholesterol / total cholesterol increased from 15 per cent to 20 per cent , which may be even more important than individual changes in HDL and LDL concentrations ...
... progression of ischaemic heart disease . In addition , the ratio of HDL- cholesterol / total cholesterol increased from 15 per cent to 20 per cent , which may be even more important than individual changes in HDL and LDL concentrations ...
Page 124
... progression of coronary artery disease : results of the NHLBI type II coronary intervention study . Circulation 69 , 325-337 . Lipid Research Clinics Program ( 1984 ) . The Lipid Research Clinics Coronary Primary Prevention Trial ...
... progression of coronary artery disease : results of the NHLBI type II coronary intervention study . Circulation 69 , 325-337 . Lipid Research Clinics Program ( 1984 ) . The Lipid Research Clinics Coronary Primary Prevention Trial ...
Page 127
... progression of CHD ( two patients ) , stroke ( 1 patient ) and death ( three patients ) . Drug compliance was very good throughout the investigation , and no drop - out was caused by the effects of the drug itself . Serum lipoproteins ...
... progression of CHD ( two patients ) , stroke ( 1 patient ) and death ( three patients ) . Drug compliance was very good throughout the investigation , and no drop - out was caused by the effects of the drug itself . Serum lipoproteins ...
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Common terms and phrases
apolipoprotein Association atherosclerosis baseline bill blood Capsules cardiovascular cent Chairman changes cholesterol cholesterol levels cholestyramine clofibrate Committee concentrations coronary heart disease decrease diabetic diet dose Drug Administration dyslipidaemic effect of gemfibrozil elevated fatty acid composition FDA approval Finland follow-up Food and Drug Framingham gemfibrozil treatment glucose HDL-cholesterol Health heart attacks Helsinki Heart Study hypercholesterolaemia hypertension incidence increase ischaemic heart disease Journal KASTENMEIER Kaukola laboratory legislation lipid lowering Lipid Research Clinics lipid-lowering lipoprotein cholesterol lipoprotein lipase lipoprotein lipase activity Lithell long-term Lopid Lopid patent low density lipoprotein LRC-CPPT male Manninen market exclusivity metabolism mmol/l mortality myocardial infarction Parke-Davis patent extension patent term extension patients pharmaceutical Phase IV study placebo Primary Prevention Trial ratio reduction regulatory risk factors Royal Society safety serum cholesterol serum lipid significant Society of Medicine Subcommittee Table Term Restoration Act therapy treatment groups triglycerides Vessby VLDL Warner-Lambert Waxman-Hatch
Popular passages
Page 113 - A simplified method for the estimation of total cholesterol in serum and demonstration of its specificity, J.
Page 113 - Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial Results, II: the relationship of reduction in incidence of coronary heart disease to cholesterol lowering.
Page 291 - Kagan A.: Serum lipoproteins and coronary heart disease in a population study of Hawaii Japanese men.
Page 73 - I am a partner in the Washington, DC law firm of Covington & Burling. I have been asked to present testimony on patent term restoration.
Page 341 - Five-year findings of the Hypertension Detection and Followup Program. I. Reduction in mortality of persons with high blood pressure, including mild hypertension.
Page 244 - For the purposes of paragraph (2)(B), the term "due diligence" means that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period.
Page 67 - HL-07182 from the National Heart, Lung and Blood Institute of the National Institutes of Health, and by the American Heart Association, Indiana Affiliate, Inc.
Page 8 - Mr. BOUCHER. Thank you very much, Mr. Chairman. I want to commend you...