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 19
... to have excess mortality in the World Health Organization clinical trial , and also because the indicators for the effect on the cardiovascular system are indirect and primarily looking at the lowering of triglycerides 19.
... to have excess mortality in the World Health Organization clinical trial , and also because the indicators for the effect on the cardiovascular system are indirect and primarily looking at the lowering of triglycerides 19.
Page 22
... to answer any questions that I could on the clinical trials of this drug or any other facets that would be of help to you . [ The statement of Dr. Young follows : ] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food 22.
... to answer any questions that I could on the clinical trials of this drug or any other facets that would be of help to you . [ The statement of Dr. Young follows : ] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food 22.
Page 25
... trial . Because this excess mortality could not be attributed to toxicity demonstrable in short - term clinical trials , the only satisfactory safety study for Lopid would be a trial of sufficient size and duration to detect excess ...
... trial . Because this excess mortality could not be attributed to toxicity demonstrable in short - term clinical trials , the only satisfactory safety study for Lopid would be a trial of sufficient size and duration to detect excess ...
Page 68
... Trial . This trial begun in 1973 was reported in January 1984. It cost NHLBI an estimated 160 million dollars and involved almost 4,000 American hypercholesterolemic men , age 35-59 . It demonstrated conclusively for the first time that ...
... Trial . This trial begun in 1973 was reported in January 1984. It cost NHLBI an estimated 160 million dollars and involved almost 4,000 American hypercholesterolemic men , age 35-59 . It demonstrated conclusively for the first time that ...
Page 69
... trial involving a similar but different lipid lowering drug had just reported out serious side effects ( the European WHO Primary Prevention Trial with Clofibrate ) . Many within FDA in fact wondered whether any new cholesterol lowering ...
... trial involving a similar but different lipid lowering drug had just reported out serious side effects ( the European WHO Primary Prevention Trial with Clofibrate ) . Many within FDA in fact wondered whether any new cholesterol lowering ...
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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...