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 43
... elevated triglycerides at risk for pancreatitis . Now , that is a very small seg- ment of the population at risk for coronary heart disease . We had sought approval and , indeed , developed the drug to treat a much broader range of ...
... elevated triglycerides at risk for pancreatitis . Now , that is a very small seg- ment of the population at risk for coronary heart disease . We had sought approval and , indeed , developed the drug to treat a much broader range of ...
Page 50
... elevated triglycerides at risk for pancre- atitis . That's a very small segment of the population at risk for coronary heart disease . We had sought approval , and indeed developed the drug , to treat a much broader range of cholesterol ...
... elevated triglycerides at risk for pancre- atitis . That's a very small segment of the population at risk for coronary heart disease . We had sought approval , and indeed developed the drug , to treat a much broader range of cholesterol ...
Page 52
... elevated levels of high - density lipoprotein cholesterol were a significant protective factor . ( Since the background details of the landmark Helsinki Study have been submitted for the hearing record , I will not dwell on them here ...
... elevated levels of high - density lipoprotein cholesterol were a significant protective factor . ( Since the background details of the landmark Helsinki Study have been submitted for the hearing record , I will not dwell on them here ...
Page 62
... elevated serum lipids , leading to atherosclerosis . Lopid synthesized and assigned # C1-719 . Was one of 8,700 compounds developed and tested to that point in the program . Ultimately , 15,000 compounds were screened . Toxicology ...
... elevated serum lipids , leading to atherosclerosis . Lopid synthesized and assigned # C1-719 . Was one of 8,700 compounds developed and tested to that point in the program . Ultimately , 15,000 compounds were screened . Toxicology ...
Page 63
... elevated triglycerides at risk for pancreatitis ) . As a condition of NDA approval , FDA had required Phase IV Study and had indicated that Helsinki Study would be a suitable Phase IV program . Second patient group ( 1,200 ) phased into ...
... elevated triglycerides at risk for pancreatitis ) . As a condition of NDA approval , FDA had required Phase IV Study and had indicated that Helsinki Study would be a suitable Phase IV program . Second patient group ( 1,200 ) phased into ...
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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...