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1.
FL Kiselev 《Canadian Metallurgical Quarterly》1997,42(6):248-251
The migration of substances from rubber packaging materials into drug products can be significant with certain packaging materials in contact with organic solvent systems. Recommendations for testing drug products for leachables are continually evolving to address new developments. Testing packaging materials using simulated solvents is not always an acceptable protocol for the pharmaceutical industry. We describe a rational strategy for evaluation of the drug product for packaging extractables. A profile of the extractables from rubber packaging materials was made with a range of organic solvents and stress conditions to provide information on substances to target in the drug product. The drug product was evaluated to determine if the matrix would cause interferences that might inhibit detection of the found extractables. Analytical methods were selected based on these findings. The procedures were validated according to FDA guidelines. A stability program using time and storage conditions as variables provided information for acceptance criteria. This same strategy can be used on other types of pharmaceuticals and packaging materials. 相似文献
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Hepatitis B virus (HBV) infection is a major health problem in the United States; in 1995, approximately 128,000 cases occurred. Transmission of HBV occurs primarily by blood exchange (eg, by shared needles during injection drug use) and by sexual contact. Persons infected early in life are much more likely to become chronically infected than those infected during adulthood: as many as 90% of infants infected perinatally develop chronic infection and up to 25% will die of HBV-related chronic liver disease as adults. Clinical signs of acute hepatitis occur in about 50% of infected adults but in only 5% of infected preschool-aged children. In the United States, hepatitis B vaccine is currently made by recombinant DNA technology using baker's yeast. Preexposure vaccination results in protective antibody levels in almost all infants and children (> 95%) and healthy adults younger than 40 years of age (> 90%). The most common adverse event following administration of hepatitis B vaccine is pain at the injection site, which occurs in 13% to 29% of adult and 3% to 9% of children. A comprehensive hepatitis B vaccination policy is now recommended that includes (1) routine infant vaccination; (2) catch-up vaccination of 11- to 12-year-olds who were not previously vaccinated; (3) catch-up vaccination of young children at high risk for infection; (4) vaccination of adolescents and adults based on lifestyle or environmental, medical, and occupational situations that place them at risk; and (5) prevention of perinatal HBV infection. 相似文献
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Retroviral display of antibody fragments; interdomain spacing strongly influences vector infectivity 总被引:1,自引:0,他引:1
S Ager BH Nilson FJ Morling KW Peng FL Cosset SJ Russell 《Canadian Metallurgical Quarterly》1996,7(17):2157-2164
Five different single-chain antibody fragments (scFv) against human cell-surface antigens were displayed on murine ecotropic retroviral vectors by fusing them to the Moloney SU envelope glycoprotein. The spacing between the scFv and the SU glycoprotein was varied by fusing the scFv to residue +7 or to residue +1 of Moloney SU and by inserting linker sequences of different lengths between the domains. All of the chimeric envelopes were efficiently incorporated into vector particles and could bind to human cells through their displayed antibody fragments, but did not infect them. The spacing between the scFvs and the SU glycoproteins had no significant effect on the efficiency of envelope expression or viral incorporation and did not affect the binding properties of the chimeric envelopes, nor did it influence the efficiency of targeted gene delivery to human cells by scFv-displaying vectors. However, on murine fibroblasts the infectivity of vectors incorporating the chimeric envelopes was strongly influenced by the length of the interdomain spacer. The titers were very low when the single-chain antibodies were fused through a tripeptide linker to SU residue +7 and were greatly enhanced (up to 10(5)-fold) when they were fused to SU residue +1 through a heptapeptide linker. These results point to the importance of steric interactions between the domains of chimeric envelope glycoproteins and may have implications for retroviral vector design for human gene therapy. 相似文献
6.
岩心PI值试验研究及应用 总被引:5,自引:0,他引:5
主要论述了在多功能采油化学用剂评价仪上进行的岩心PI值试验的步骤,现象及结论。重点考察了岩心PI值与渗透率、流量及注入截面面积的关系;平行管岩心复合PI值和其中单管岩心PI值的关系。 相似文献
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The present study was undertaken to evaluate the postoperative relapse from the period of unwiring to 1 year postoperatively and its correlation to the amount of mandibular setback and change in vertical dimension after mandibular bilateral sagittal split osteotomy. Twenty-seven patients were evaluated cephalometrically by the time preoperatively, 6 weeks, 6 months and 1 year postoperatively. It was found that 1) the average amount of mandibular setback at pogonion point, 6 weeks postoperatively, is 7.6mm backward and 1.9mm downward, 2) the average amount of horizontal relapse at pogonion point, 6 months and 1 year postoperatively, are 1.9mm and 2.3mm respectively. 86% of the horizontal relapse, 1 year postoperatively, occurs in the first 6 months after removal of intermaxillary fixation, 3) the average amount of vertical relapse at pogonion point, 6 months and 1 year postoperatively, are 0.9mm and 1.1mm upward. 82% of the vertical relapse, 1 year postoperatively, occurs in the first 6 months after removal of intermaxillary fixation, 4) the amount of 1 year postoperatively horizontal relapse is significantly correlated both with the amount of horizontal mandibular set back and vertical downward change (r = 0.58, 0.67, p < 0.001), whereas the amount of vertical relapse is with the vertical downward change only, but horizontal setback isn't. 相似文献
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PURPOSE: We determined the impact of preexisting co-morbidities on survival of men with clinical stages T1b and T2NXM0 prostate cancer treated with surgery or radiation therapy. MATERIALS AND METHODS: A weighted co-morbidity score was determined for 276 consecutive men treated with surgery (138) or radiation therapy (138) at a Veterans Affairs medical center and was correlated with actuarial freedom from death due to co-morbid disease. RESULTS: After a median potential followup of 7.0 years 91 patients (33%) died of co-morbid disease and 20 (7%) died of cancer related causes. There were highly significant correlations between actuarial survival and weighted co-morbidity (p < 0.000001), and the 10-year actuarial survivals in men with no or severe co-morbidities were 66 and 9%, respectively. Associations between patient age and co-morbidity score were highly significant (p < 0.0001). The age adjusted risk of co-morbid death was 5.7 times greater in men with severe compared to no co-morbidities. There were also significant correlations between actuarial survival and weighted co-morbidity among patients treated with surgery (p = 0.02) and radiation therapy (p = 0.0002). Patient age and severity of co-morbidities were significantly greater among men treated with radiation therapy compared to surgery, and age adjusted risk of co-morbid death among men with a co-morbidity score of 1 was 3.8 times greater among men treated with radiation therapy (p = 0.025). CONCLUSIONS: Cancer related deaths are unusual within 5 to 10 years after surgery or radiation therapy in men with stages T1b and 2 prostate cancer. The risk of death during this interval is directly related to the severity of co-morbid conditions, which should be factored in an individual when assessing the advisability of therapeutic intervention. Since patient co-morbidities impact all cause survival, quantitative assessment of co-morbidities using validated instruments offers a method to control partially for the variabilities of health status among men receiving different treatments for localized prostate cancer. 相似文献
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A card survey was sent to 340 veterinarians in the Urban, Delta, Highland and Coastal Plain regions of Arkansas. Veterinarians were asked to indicate numbers of dogs tested, confirmed Dirofilaria immitis positive, diagnostic techniques, frequency and period tested. A significantly greater percentage of dogs tested D. immitis positive in the Delta region as compared with the Urban region. There were no significant differences in the percentage of treated dogs on prophylaxis or the types of diagnostic tests among regions. 相似文献