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13 recordsLinked to original sources
PubMed1997

Comparison of commercially available kits with standard methods for detection of Salmonella strains in foods.

Six commercial kits were compared with the U.S. Food and Drug Administration (USFDA) method and the Japanese standard method for Salmonella isolation in foods. When only Salmonella serovars were tested, many of the methods performed well; however, when foods were artificially inoculated, only the USFDA method and immunomagnetic separation coupled with the xylose-lysine-brilliant green agar method (MS-XLBG) could positively detect Salmonella serovars. All seven wild-type Salmonella serovars were detected by the USFDA method, and the MS-XLBG method detected salmonellae from six samples.

Bacterial Typing Techniques↗
PubMedDate not supplied

Bioavailability of seven furosemide tablets in man.

A seven-way crossover study was conducted in 14 healthy male volunteers to evaluate the relative bioavailability of seven different marketed 40 mg furosemide tablets. Each dose was administered as a single tablet after an overnight fast, and blood samples were obtained for 16 hours. Plasma was assayed by HPLC. There were no statistically significant differences among the seven products for the mean peak concentration (1.01-1.29 micrograms/ml), mean time of peak (1.2-2.1 h) or mean area under the plasma concentration-time curves, which differed by less than 14 per cent. However, one product exhibited greater intersubject variability, and on this basis was considered inequivalent to the other six products. Furosemide is a potent and widely used diuretic. Currently the United States Food and Drug Administration (USFDA) has granted approval to at least twelve manufacturers of 40 mg furosemide tablets, based in part on bioavailability data obtained in human subjects. In addition, the USFDA has granted an 'AB' therapeutic equivalence evaluation to each of these products, which is understood by many to indicate the therapeutic equivalence and interchangeability of these products. The objective of the present investigation was to directly compare the bioavailability of seven 40 mg furosemide tablet products which had previously been approved by the Food and Drug Administration.

Adult↗
PubMed1996

Transfer of lead from lead-glazed ceramics to food.

Recent studies have shown a clear correlation between the use of lead-glazed ceramicware for cooking or food preparation and elevated blood lead levels. Two lots of lead-glazed ceramic bowls, each from a single manufacturing and firing lot were used to measure the sequential leaching of lead into salsa (an acidic food) and beans (a neutral food) stored or cooked in the bowls. The USFDA acetic acid extraction assay was also repeatedly performed on these bowls. The results of the USFDA extraction test were highly variable with levels ranging from 200 to more than 2,000 ppm (regulatory level for rejection is 2 ppm). The levels extracted declined rapidly but the rates were variable. Leaching of lead into salsa (pH = 4.8) was variable and ranged from 8 to greater than 500 ppm. Sequential extractions using salsa yielded variable but declining lead levels. Cooking beans with water in the bowls did not cause substantial leaching (levels between 3 and 8 ppm) and sequential cooking did not show any significant decline over 10 cycles. The results indicate substantial variability in leaching of lead into foods stored or cooked in lead-glazed ceramicware.

Acids↗
PubMedDate not supplied

Haemophilus influenzae type B epiglottitis after immunization with HbOC conjugate vaccine.

INTRODUCTION: US Food and Drug Administration (USFDA) has licensed four Haemophilus influenzae type B (Hib) vaccines for use in children. Haemophilus influenzae type B is by far the most common pathogen in childhood epiglottitis and it is hoped that with the introduction of the Hib vaccine that a corresponding decrease in epiglottitis cases will be appreciated. MATERIALS AND METHODS: A retrospective study of all children admitted with the diagnosis of epiglottitis for the 11-year period of 1982 to 1992 was conducted in order to determine the incidence of epiglottitis and Hib vaccine failure. Fifty-nine cases were included in the study by documentation of an inflamed epiglottis. The case of Hib epiglottitis in a 4-year-old child immunized with HbOC conjugate vaccine at 18 months of age is detailed. RESULTS: A statistically significant decrease was found in the incidence of epiglottitis since introduction of the vaccines; however, the overall trend in decrease for the 11-year period was not statistically significant. Vaccination status was difficult to accurately document with only two cases of vaccine failure identified. CONCLUSION: The incidence of Haemophilus influenzae type B epiglottitis at our regional Children's hospital has decreased since the introduction of the Hib vaccine. Reasons for vaccine failure are postulated.

Bacterial Proteins↗
PubMedDate not supplied

Polychlorinated biphenyl residues in various fatty foods consumed in Guipúzcoa, the Basque Country (Spain).

Three congeners of polychlorinated biphenyls (PCBs)--the 2, 2', 3, 4, 4', 5'-, 2, 2', 4, 4', 5, 5'-hexachloro, and 2, 2', 3, 4, 4', 5, 5'-heptachlorobiphenyls--were determined in 18 samples of butter, 44 of fish (hake and anchovy) and 24 of egg, all of which came from markets in Guipúzcoa. The total content as Araclor 1260 was also determined. Quantitation was carried out by gas chromatography in a capillary column and electron capture detector. The total content in butter ranged from 20 to 60 ng/g (fat basis), in fish from 10 to 250 ng/g (edible part), and in eggs from 1 to 10 ng/g (edible part). None of these exceeded the tolerance limits established by the Canadian Government Guideline and USFDA.

Animals↗
PubMed1997

An in vitro evaluation of condoms as barriers to a small virus.

BACKGROUND: Because of the possible presence of small holes, the effectiveness of condoms as barriers to virus transmission is controversial. GOALS: To determine the proportion of condoms that allow virus penetration and the amounts of virus that penetrate. STUDY DESIGN: A sensitive, static test was used to evaluate different condom types as barriers to a small virus, including brand with or without lubrication and ones of different materials. The test included some physiologic-based parameters and some parameters that exaggerated expected actual use conditions. RESULTS: Under test conditions, 2.6% (12 of 470) of the latex condoms allowed some virus penetration; the median level of penetration was 7 x 10(-4) ml. Lubricated condoms performed similarly to nonlubricated ones. Polyurethane condoms yielded results higher than but not statistically different from those for latex condoms. CONCLUSIONS: Few condoms allowed any virus penetration. The median amount of penetration for latex condoms when extrapolated to expected actual use conditions was 1 x 10(-5) ml (volume of semen). Thus, even for the few condoms that do allow virus penetration, the typical level of exposure to semen would be several orders of magnitude lower than for no condom at all.

Bacteriophage phi X 174↗
PubMed1994

Long-acting injectable contraception with depot medroxyprogesterone acetate.

Depot medroxyprogesterone acetate (DMPA) is the only injectable contraceptive available in the United States. After more than 20 years of regulatory review, the Food and Drug Administration approved DMPA for contraceptive use in 1992 after the publication of reassuring data about its possible association with breast cancer. It has been used by 30 million women in more than 90 countries. The recommended dosage, 150 mg intramuscularly every 3 months, has a contraceptive efficacy exceeding 99%. After a 150 mg dose, ovulation is inhibited for at least 14 weeks. Almost all users experience menstrual changes, typically episodes of unpredictable irregular spotting and bleeding, particularly during the first year of use. With continued use, spotting and bleeding decrease, and amenorrhea becomes common. Although ovulation suppression may rarely persist for as long as 18 months after the last injection, DMPA does not permanently affect fertility. Long-term DMPA use reduces menstrual blood loss, has been associated with a decreased incidence of candidal vulvovaginitis and pelvic inflammatory disease, and dramatically lowers the risk of endometrial cancer. Prolonged DMPA use may be associated with reversible reduction in bone density, probably related to suppression of endogenous production of estrogen. The most recently published data suggest that long-term use of DMPA induces moderate changes in lipid metabolism that are unfavorable in terms of risk of atherosclerosis. DMPA should be considered a highly effective, safe, convenient, and reversible contraceptive option for appropriately selected patients.

Delayed-Action Preparations↗
PubMed1994

A reanalysis of the Cu-7 intrauterine contraceptive device clinical trial and the incidence of pelvic inflammatory disease: a paradigm for assessing intrauterine contraceptive device safety.

OBJECTIVE: We calculated and compared the incidence of pelvic inflammatory disease in a 10% random sample of the Cu-7 intrauterine contraceptive device (G.D. Searle & Co., Skokie, Ill.) clinical trial with the rates reported to the Food and Drug Administration and those in subsequent trials published in the world literature. STUDY DESIGN: A 10% random sample of the Cu-7 clinical trial was examined because calculations had demonstrated this random sample to be sufficient in size (n = 1614) to detect a difference in rates of pelvic inflammatory disease from those reported to the Food and Drug Administration. An audit of a subset of the patient files, compared with the original files in Skokie, Illinois, confirmed that the files available for analysis were complete. Standard definitions were used to identify cases of pelvic inflammatory disease and to calculate rates of pelvic inflammatory disease. The world literature on Cu-7 clinical trials was reviewed. RESULTS: The calculated crude and Pearl index rates of pelvic inflammatory disease were consistent with those rates previously reported to the Food and Drug Administration and published in the medical literature. Life-table pelvic inflammatory disease rates were not different between nulliparous and parous women and pelvic inflammatory disease did not differ from basal annual rates in fecund women. CONCLUSION: On the basis of the analysis of this 10% sample, the pelvic inflammatory disease patient rates reported to the Food and Drug Administration for the entire Cu-7 clinical trial are accurate and are similar to those published in the world literature.

Adult↗
PubMed1996

Emergency contraception, a method whose time has come: an update.

Unplanned pregnancy is a major public health problem in the United States. Emergency contraception has the potential to significantly decrease the incidence. The Yuzpe regimen is highly effective but woefully underutilized. Mechanisms of action of hormonal emergency contraception will be discussed as well as appropriate indications for use, patient counseling issues, and future methods.

Contraceptives, Postcoital, Hormonal↗
PubMedDate not supplied

A sensitive method for evaluating condoms as virus barriers.

A standard test is needed to evaluate condoms as barriers against sexually transmitted diseases, particularly those caused by viruses. The proposed method presented here consists of a previously published simple method using physiologic-based conditions plus improvements to increase test sensitivity and decrease confounding factors such as contamination. Limitations of the method were determined by measuring virus penetration through small, well-defined holes. The method can detect penetration of 2 nL (2 x 10(-6) mL) of challenge virus suspension as well as a hole of 2 microns diameter in a latex condom. The data also indicated that virus penetration of latex condoms occurred quickly, and the hole was then apparently closed or blocked.

Bacteriophage phi X 174↗