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 21
... changes which would influence death of pa- tients , you can certainly say that a drug is clearly effective . In all ... changes but changes that will affect the well - being of a patient . It is our understanding that the data have been ...
... changes which would influence death of pa- tients , you can certainly say that a drug is clearly effective . In all ... changes but changes that will affect the well - being of a patient . It is our understanding that the data have been ...
Page 39
... change , a change of lowering triglycerides , a change of lowering cholesterol . There was a nagging question in the Agency : Does that change in and of itself indicate a decrease in morbidity and mortality ? That was the reason for the ...
... change , a change of lowering triglycerides , a change of lowering cholesterol . There was a nagging question in the Agency : Does that change in and of itself indicate a decrease in morbidity and mortality ? That was the reason for the ...
Page 70
... change in scientific perception and with the passage of the 1984 patent legislation , Warner Lambert finds itself about to lose Gemfibrozil's patent rights exactly at the time that their clinical trial is concluding . This all does not ...
... change in scientific perception and with the passage of the 1984 patent legislation , Warner Lambert finds itself about to lose Gemfibrozil's patent rights exactly at the time that their clinical trial is concluding . This all does not ...
Page 93
... changes in plasma lipid fatty acid composition were observed , and there were no changes in blood glucose , glucose tolerance , or serum insulin concentrations . Gemfibrozil has been shown to lower serum triglyceride levels as well as ...
... changes in plasma lipid fatty acid composition were observed , and there were no changes in blood glucose , glucose tolerance , or serum insulin concentrations . Gemfibrozil has been shown to lower serum triglyceride levels as well as ...
Page 94
... changes occurring during gemfibrozil treatment . Materials and methods Patient population Seventeen patients , 13 males ( mean age 60 years ; range 46-76 ) and four females ( mean age 68 years ; range 62-78 ) were investigated in an ...
... changes occurring during gemfibrozil treatment . Materials and methods Patient population Seventeen patients , 13 males ( mean age 60 years ; range 46-76 ) and four females ( mean age 68 years ; range 62-78 ) were investigated in an ...
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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...