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Method for evaluating drug information systems.

A method for evaluating drug information systems is described. The method measures both qualitative and quantitative performance. For the categories, "Basic Therapeutic Information", and "Commercial and Investigational Product Information," specific data that should be present are identified; evaluated systems are searched for these data related to a standard sample of 122 drugs. Systems are also searched for the presence of any information relating to these drugs in the categories, "Applied Clinical Research Information" and "Nonclinical Laboratory Research Information". In addition, systems are searched for the presence of 215 drug-drug interactions and 244 drug-laboratory test interferences. Using relative weights that have been assigned to the content statistics, an aggregate measure of system's content is determined. The method also measures annual cost of operating a system. The application of the method to two drug information systems is discussed briefly.

Computers

In vivo antitumor evaluation of antibiotics. Selected results from the Drug Evaluation Program of the National Cancer Institute, U.S.A.

A summary is given of the in vivo screening results for selected antitumor antibiotics in various stages of the National Cancer Institute drug development program. In addition a brief description of general screening practices of the program is given. After long-term usage of leukemia L1210 as a primary screen, a new screening panel is being initiated with P388 leukemia as a prescreening system. Illustrative data on anguidine, actinomycin D, macromomycin, aclacinomycin, and other fermentation products are shown.

Animals

Hyperkinetic children: the use of stimulant drugs evaluated.

Use of stimulant drugs in the treatment of hyperkinetic children is reviewed briefly. While drugs appear to be effective in "normalizing" behavior, too little attention has been paid to potential side effects. There is need for a broader program of clinical evaluation, assessing drug effects not only on behavior, but on appetite and the cardiovascular system, and taking into account the sociological impact of drug use by children.

Achievement

Drug evaluation after marketing.

After marketing, drugs should be evaluated for safety and for efficacy. Present national systems are inadequate for both tasks. Safety can be evaluated by means of nonexperimental research, whereas evaluation of efficacy in a variety of settings representing normal medical practice generally requires experiments, randomized and blinded. Research into safety requires the maintenance of routine, yet flexible, multipurpose data systems, different for established and newly marketed drugs. Ad hoc studies on safety and on efficacy can be mounted more swiftly and economically through the maintenance of "standby" capabilities, in addition to maximal use of resources outside the actual national system.

Drug Evaluation

Transcutaneous oxygen measurement to evaluate drug effects.

The evaluation of pharmacologic effects in perinatal medicine is dependent on our clinical methods for measurement and monitoring of the mother, the fetus, and the newborn infant. The development of a noninvasive continuous method of measuring PO2, the transcutaneous PO2 electrode, has greatly enhanced the ability to assess effects of drugs on the cardiorespiratory system. During labor, diazepam and meperidine have been documented to cause respiratory depression and significant decreases in PO2. The advantageous effect of epidural anesthesia on the oxygen-cardiorespirogram of mothers in labor has also been demonstrated. Both fetal and maternal tcPO2 have been successfully assessed during the administration of peridural catheter anesthesia (carticaine) and during suppression of labor with fenoterol. In the newborn infant, monitoring of tcPO2 has been helpful in assessing the residual effects of drugs administered during labor and delivery, in prescribing the appropriate and safe dose of oxygen, and in defining the effects of theophylline on the oxygen-cardiorespirogram. We have also demonstrated the effect of furosemide on PO2 in the treatment of pulmonary edema accompanying bronchopulmonary dysplasia and of indomethacin for the management of patent ductus arteriosus. Use of tcPO2 measurements for clinical pharmacologic evaluation is a promising addition to our research techniques.

Anesthesia, Obstetrical

Statistical considerations on the parameters in drug evaluation.

Some fundamental considerations are described on the parameters in clinical drug evaluation, and on the combination of them into a judgement on the usefulness of the drug. Regardless of the types of study, informal exploratory or formal controlled study, we must recognize that we work in the clinical field where many pitfalls of variability and bias are ambushing us.

Clinical Trials as Topic

Drug evaluation on haemopoietic cells in vitro. I. A micro agar colony assay with semi-automatic optical monitoring.

A micro method was developed to culture myelomonocytic colonies from mouse bone marrow cells in semi-solid agar contained in glass capillary tubes. Parameters affecting colony formation in capillaries were studied. An optical, semi-automatic scanning system using the light scattering properties of the colonies was developed; the system was mostly composed of commercially available equipment. The daily growth of single colonies within the tubes was followed. Combined with the capillary technique the scanning system provides an easy, accurate and sensitive method to quantitate the formation of haemopoietic colonies. This is the basis of a micro assay for the evaluation (screening) of drug effects on mammalian cell colonies in vitro offering several advantageous features.

Agar

Sex differences in drug evaluations.

Twenty normal, nonobese subjects (10 males and 10 female) were administered a battery of seven psychomotor tests as well as affect checklists and physiological measurements on 6 alternate days. Subjects performed the entire battery predrug and at 45,90, and 135 min postdrug. Fenfluramine, dextroamphetamine, two combined doses of the drugs, and a placebo were given in a double-blind, repeated measures design. Findings revealed significant sex-based differences in initial performance on five of the seven psychomotor tasks and in two physiological measures, with males performing at higher levels than females. Additionally, sex differences in postdrug changes were found in three psychomotor and two physiological measures, with females evidencing greater change scores than males.

Adult

AMA drug evaluations.

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American Medical Association