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STUDIES ON BACTERIAL PYROGENICITY. 3. SPECIFICITY OF THE UNITED STATES PHARMACOPEIA RABBIT PYROGEN TEST.

The specificity of the first or "presumptive" portion of the USP rabbit pyrogen test was investigated by use of a new absolute standard of reference. The reference standard was a 0.9% sodium chloride solution prepared to be pyrogen-free. Details of the preparation were described. The hypothesis was explored that the temperature response of rabbits after intravenous injection of the standard solution was independent of exogenous pyrogen. Reactions observed among the rabbits in our colony allowed a classification of these animals ranging from "consistently reliable" to "consistently unreliable." Details of the experimental results and implications for pyrogen testing are discussed. The recommendation was made that all rabbit test animals be "screened" in sham and actual tests before being used for pyrogen testing.

Animals↗

Monastic incorporation of classical botanic medicines into the Renaissance pharmacopeia.

Ancient Greek physicians believed that health resulted from a balance of natural forces. Many, including Dioscorides, made compilations of plants and medicines derived from them, giving prominence to diuretics, cathartics and emetics. During the Roman Empire, although Greek physicians were highly valued, the Roman matron performed many medical functions and magic and astrology were increasingly used. In Judaic and later Christian societies disease was equated with divine disfavor. After the fall of Rome, the classical Greek medical texts were mainly preserved in Latin translation by the Benedictine monasteries, which were based around a patient infirmary, a herb garden and a library. Local plants were often substituted for the classical ones, however, and the compilations became confused and inaccurate. Greek medicine survived better in the remains of the Eastern Roman Empire, and benefitted from the influence of Arab medicine. Intellectual revival, when it came to Europe, did so on the fringes of the Moslem world, and Montpellier and Salerno were among the first of the new medical centers. Rather than relying on ancient experts, the new experimental method reported the tested effects of substances from identified plants. This advance was fostered by the foundation of universities and greatly aided by the later invention of the printing press, which also allowed wider dissemination of the classical texts.

Byzantium↗

Particle size analysis: AAPS workshop report, cosponsored by the Food and Drug Administration and the United States Pharmacopeia.

The concepts of particle engineering and dosage form design have become dominant themes in pharmaceutical manufacturing. This trend is not simply a reflection of the development of new, more sophisticated manufacturing methods of particles or dispersed systems but also recognition of the importance of quality control even in more traditional manufacturing processes. However, the diversity of particle treatments, methods of particle size analysis, expression and interpretation of data, and process applications results in complicated and sometimes confusing criteria for selection, adoption, or relevance of the available techniques.

Particle Size↗

Medication errors: experience of the United States Pharmacopeia (USP) MEDMARX reporting system.

Medication errors are pervasive in America's health care system. MEDMARX is an Internet-accessible, anonymous medication error reporting program designed for hospitals and health systems to systematically collect, analyze, and report medication errors. This study examined 154,816 medication error reports that were submitted to MEDMARX between January 1, 1999, and December 31, 2001. Data fields analyzed were error category (based on the National Coordinating Council for Medication Error Reporting and Prevention's Error Category Index), type(s) of error, cause(s) of error, contributing factor(s), and product(s) involved. Approximately two-thirds of the errors reported reached the patient, with relatively few causing harm. Death was reported in 19 occurrences. Errors of omission and improper dose/quantity were the most commonly reported. Performance deficit and procedure/protocol not followed were consistently identified as causes of error. Distractions and workload increase were often cited as contributing factors. There was a similar pattern of products reported in each of the years. Implications for quality assurance, clinical practice, and health policy are presented.

Adverse Drug Reaction Reporting Systems↗