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At least 19 recordsLinked to original sources
PubMedDate not supplied

The determination of the absolute bioavailability for drug substances with long elimination half-lives (with PC-programs for the method of truncated areas).

A survey is given of the methods for the determination of the absolute bioavailability for drug substances with long elimination half-lives. All methods depend on the assumption of linear pharmacokinetics. Emphasis is laid on Urso and Aarons' regression method of truncated areas-under-the-curve (AUC) to obtain estimates of the absolute bioavailability, F, and the absorption rate constant, ka, without obeying the otherwise general rule of following blood or plasma levels for at least three times the terminal half-life. It is shown by simulation when the linear and when the logarithmic trapezoidal rule is to be used for the calculation of the AUC. Two PC-programs for the regression method of truncated areas are presented: one program (SIMF&KA.EXE) simulates, based on tentative pharmacokinetic parameters, whether a blood sampling scheme, together with the precision of the analytical assay, is adequate to obtain accurate and precise estimates of F and ka; the method is insensitive to large variations in the tentative value of the elimination half-life. The other program (ESTF&KA.EXE) provides estimates of F and ka, with standard deviations of the estimates, from empirical data.

Biological Availability↗
PubMed1992

Aeromedical transport services accepting pediatric patients and their abidance by published guidelines.

The number of aeromedical transport services accepting pediatric patients (ATSP) in the United States has increased greatly over the past decade. Most aeromedical transport services are primarily designed for adults but will also transport children. Suggested guidelines for ATSP were published by the American Academy of Pediatrics (AAP) in 1986. This survey of 65 ATSP and their abidance by the major AAP guidelines showed that two thirds of the ATSP were based at facilities with pediatric tertiary care capabilities; most ATSP were not directed by pediatric critical care (PCC) or pediatric emergency care (PEC) specialists; most transport team personnel were not trained in PCC or PEC; most ATSP had specific protocols for different clinical situations; most ATSP had separate equipment appropriate for pediatric patients; and there was little variation in transport team composition based on different clinical situations. In summary, all ATS surveyed transported children, but few were aware of the AAP guidelines, and only one in 65 was in complete abidance with the recommendations.

Adult↗
PubMed1992

The Quality of Life Committee of the Clinical Trials Group of the National Cancer Institute of Canada: organization and functions.

The Quality of Life Committee of the National Cancer Institute of Canada Clinical Trials Group has successfully advocated the adoption of quality of life outcomes in Canadian clinical trials in patients with cancer. It has developed a policy promoting quality of life assessment in phase III trials and developed writing guidelines to assist clinical investigators when developing protocols for proposed studies. As a result, all phase III clinical trials instituted since the policy was developed have quality of life assessment as a part of their objectives. It has assisted the Clinical Trials Group office personnel in the development of procedures for the conduct of quality of life assessments in clinical trials with the result that the completion rate of self-report questionnaires is very high. The Committee maintains contact with other clinical trials groups and organizations having an interest in measuring quality of life in cancer.

Canada↗
PubMed1992

An analysis of the U.S. Environmental Protection Agency neurotoxicity testing guidelines.

Few of the more than 65,000 chemicals listed in the Environmental Protection Agency (EPA) inventory have been tested for neurotoxicity. The nervous system may be especially vulnerable to toxicants because many compounds can cross the blood-brain barrier and induce irreversible damage. Additionally, the young, the elderly, and other sensitive populations may be particularly susceptible to neurotoxic injury. The EPA has developed guidelines including neurobehavioral, neuropathological, and neurochemical tests for the identification of possible neurotoxicants. In the present review, tests included in the current EPA guidelines for neurotoxicity testing are described and evaluated. The main benefit of the tests is that regulators are familiar with them, thus facilitating interpretation. Additionally, validation data on these tests are available for many known neurotoxicants. These factors make it difficult to introduce new methods that may include in vitro and other techniques. The current in vivo tests can be costly and prolonged and can involve the use of many laboratory animals, making them inappropriate for generalized use on existing chemicals. It is suggested that alternative tests be incorporated for screening of large numbers of chemicals and that testing priority be given to chemicals on the basis of structure/activity relationships, lipophilicity, bioaccumulation, and extent of exposure.

Animals↗
PubMed1990

The National Cholesterol Education program: guidelines and commentaries.

There is overwhelming evidence that atherosclerosis is caused by elevated cholesterol levels and that the process can be prevented, arrested, and even reversed by altering the cholesterol fractions. The National Cholesterol Education program established guidelines for the management of hypercholesterolemia. Classification of cholesterol values are: Desirable 200 mg./dl, Borderline high 200-239 mg./dl high risk 240 mg./dl and above. Total cholesterol is used for case finding and screening, but LDL cholesterol is the key index for decisions requiring treatment. Classification of LDL levels is as follows: High risk 160 mg/.dl and over, Borderline 130 to 159 mg./dl, Acceptable 130 mg./dl and below. Secondary and familiar disorders should be identified. Dietary therapy is the cornerstone of cholesterol reducing interventions. Steps one and two diets are described, with limitations of saturated fats to 10% of total calories and cholesterol to 300 mg./daily in step one; step two diet limits saturated fats to 7% of total calories-and cholesterol to 200 mg./daily. Pharmacotherapy is based on 5 groups of hypolipidemics agents: A--Resins (cholestyramine and colestipol) B--Nicotinic acid C--Probucol D--Fibric acids (gemfibrozil) E--Reductase inhibitors (lovastatin). Some areas of criticism and controversies regarding the guidelines are discussed and identified.

Humans↗
PubMed1991

Statistical guidelines for The British Journal of Surgery.

A set of statistical guidelines is presented which should be followed by authors preparing manuscripts for submission to The British Journal of Surgery. Simple points relating to presentation are explained in full, and more complex issues are highlighted and discussed in an accompanying review article.

Periodicals as Topic↗
PubMed1992

Issues of concern in the standardization and harmonization of drug trials in Europe: health-related quality of life, ESCT meeting, Strasbourg, 23-24 May 1991.

Overviews of the development of the concept of quality of life from a medical viewpoint, and the need for new models and methods to assess health-related quality of life were presented, along with WHO, FDA and European regulatory viewpoints and a discussion on the measurement and valuation of health by social judgement, at the health-related quality of life session at an ESCT meeting on issues of concern in the standardization and harmonization of drug trials in Europe. It was concluded that, for the present, all three types of measurements of quality of life--individual, disease-specific, and generic scales--should be used in research to look for convergent versus divergent validity.

Clinical Trials as Topic↗
PubMedDate not supplied

Blueprint for a research career in general internal medicine.

An academic career in general internal medicine is a challenging but rewarding endeavor. The strategies for success require flexibility as the ground rules may change. Nevertheless, attention to the aforementioned principles will help the academic generalist to swim with sharks and survive, and simultaneously to promote the entire field of academic general internal medicine.

Employment↗
PubMed1990

Effective use of patient education illustrations.

Effective illustrations can greatly enhance patient education materials, yet many illustrations do not aid instruction as much as they could. By following the above recommendations, patient education materials developers and illustrators can together accomplish their objectives.

Audiovisual Aids↗