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PubMed2001

Influence of hepatic impairment on everolimus pharmacokinetics: implications for dose adjustment.

OBJECTIVE: We assessed the influence of hepatic impairment on the pharmacokinetics of the immunosuppressant everolimus to provide dose recommendations for clinical use. METHODS: In this open-label, single-dose, case-control study, 8 subjects with liver cirrhosis classed as moderate hepatic impairment (Child-Pugh score, 7-9) and 8 demographically matched healthy control subjects received a single oral 2-mg dose of everolimus. Routine safety assessments were made, and blood samples were taken for determination of everolimus concentrations and protein binding. RESULTS: The apparent clearance of everolimus was significantly reduced by 53% in subjects with moderate hepatic impairment compared with healthy subjects (9.1 +/- 3.1 versus 19.4 +/- 5.8 L/h). This was manifested by a 115% higher area under the blood concentration-time curve (AUC) (245 +/- 91 versus 114 +/- 45 ng. h/ml) and 84% prolonged half-life (79 +/- 42 versus 43 +/- 18 hours) in subjects with hepatic impairment. The rate of absorption of everolimus was not altered by hepatic impairment on the basis of the maximum blood concentration (C(max)) and time to reach C(max) (t(max)). Protein binding was similar in the two groups (73.8% +/- 3.6% versus 73.5% +/- 2.4%). A significant positive correlation of the everolimus AUC with bilirubin level (r = 0.86) and a significant negative correlation with albumin concentration (r = 0.72) was observed. CONCLUSIONS: The dose of everolimus should initially be reduced by half in patients with mild and moderate hepatic impairment on the basis of the Child-Pugh classification. Therapeutic monitoring would be a helpful adjunct to subsequent titration of everolimus exposure in this subpopulation. Everolimus has not been assessed in patients with severe hepatic impairment.

Adult↗
PubMed1992

A nonradioactive micro-assay for released reverse transcriptase activity of a lentivirus.

A nonradioactive micro-assay procedure for detection of released reverse transcriptase activity from cells infected with equine infectious anemia virus is described. This procedure utilizes biotinylated-dUTP in conjunction with a streptavidin-alkaline phosphatase conjugate. Detection of alkaline phosphatase is by autoradiography of the chemiluminescence produced during enzymatic dephosphorylation of Lumi Phos 530. This method, as with reverse transcriptase micro-assays employing 32P-labeled nucleotides, is suited to the processing of numerous samples, while having the advantages of safety and stability normally associated with nonradioactive methods of detection. Sensitivity is comparable to a reverse transcriptase micro-assay using 32P-dTTP.

Alkaline Phosphatase↗
PubMed2003

Improving quality measurement using multiple data sources.

We calculated a sample of AHRQ Quality and Patient Safety Indicators for UVa hospitalized patients over a 3 year period using diagnoses and procedure codes from two different billing systems. Significant differences in results were observed suggesting that quality indicators calculated from hospital billing sources alone may be understated.

Current Procedural Terminology↗
PubMed2004

Lessons from preventive infectious disease vaccines.

Preventive vaccines for infectious disease indications are regulated by the Office of Vaccines Research and Review, CBER, FDA. FDA-regulated biological products, including vaccines, must be safe, pure, potent, and manufactured consistently according to current Good Manufacturing Practices. Regulatory issues include common principles of vaccine production and quality control, lot release testing, vaccine preclinical data, and clinical development. For Phase 3 studies, the following should be addressed: the case definition of the disease that the vaccine is intended to prevent (piloted during Phase 2) and the sample size to support efficacy and safety considerations. Also during development, validation data for immunological and other critical assays, clinical lot consistency studies, and the possible need for bridging studies, e.g., to support manufacturing changes or extrapolation to different populations, should be addressed.

Bacterial Vaccines↗
PubMedDate not supplied

[Antibiotic prophylaxis in cardiovascular surgery: comparison of sulbactam-ampicillin and cefuroxime].

A total of 200 patients (131 males and 69 females), scheduled for cardiovascular surgery were randomly assigned to receive either sulbactam/ampicillin 1 g IV of cefuroxime 2 g IV before the surgical incision and then, postoperatively, 8-hourly x 3 days. There were five failure of prophylaxis (all in the cefuroxime group): 3 sternal incision abscesses (1 Pseudomonas aeruginosa and 2 Staphylococcus epidermidis), one urinary tract infection (Staphylococcus aureus) and one Micrococcus pneumoniae. Tolerance to both antibiotics was excellent. In our sample of patients, the efficacy and safety of sulbactam/ampicillin were not different from those of cefuroxime in prophylaxis in cardiovascular surgery.

Ampicillin↗
PubMed1993

Prenatal diagnosis and fetal therapy.

The protective effect of folic acid supplementation has been demonstrated in patients at risk of neural tube defects by a large, randomized double-blind study. The feasibility of second-trimester screening for Down syndrome, based on the combination of maternal and biochemical markers on maternal blood, has also been verified in two large series from both the United Kingdom and the United States. These results represent major advances in the field of prenatal diagnosis, which, in the future, is likely to rely more and more on better selection by noninvasive testing of high-risk patients. The emphasis has moved away from very early invasive testing due to concerns related to the safety of both early chorionic villus sampling and amniocentesis. Evaluation of renal damage in fetuses with obstructive uropathy by analysis of urinary biochemistry may constitute the basis for more efficient selection of cases amenable to antenatal treatment. Twin-to-twin transfusion syndrome remains a challenge for the future.

Congenital Abnormalities↗
PubMed2003

[Health Polish foods as the chance for Polish agriculture in the united Europe].

This paper discuss the matter of food quality and safety which is available for whole population in Poland in 2001. The results of the nation wide control survey of food safety in 2001 conducted by the State Sanitary Inspection, where used as the source of data. Those results concerned 233.249 samples of foodstuffs taken from the market to assess. Based on the results of laboratory analysis of microbiological, chemical and physical contaminations in food and regarding organoleptic quality and labelling, the samples of foodstuffs were assessed. There were 24 of foodstuffs assortment in the survey distinguished. The result of this survey were discussed in the background of the changes in food industry in Poland during the last decade of XX century. The results show that over 88% of whole examined samples of food available for consumers in 2001 came from the health safety food. Generally the reason of the call in question of food safety were microbiological contaminations. It concerned 11% of examined samples. Chemical contaminants were detected in 3.48% of food samples and biological contaminants--in 1.77%. More over 1.13% samples because of inappropriate organoleptic food features where the reason of withdrawal them from the trade. Incorrect labelling was the reason of disqualification in 1.5% samples. Appearance of extraneous elements detected in 0.5% of samples. As result from gathering dates many of contaminated food samples were disqualified from a few reasons. From among 24 of foodstuffs assortment the samples of meat processing products were most often disqualified. The smallest percentage of disqualified food samples was observed in the group of foodstuffs for particular nutritional uses for infants. Strengthening of internal control system in production and processing establishment, rapid implement of Hazard Analysis and Critical Control Point (HACCP) in establishment and improve official control of foodstuffs system are the most important directions of activities in order to improve food safety in our country.

Agriculture↗
PubMed1999

Screening for HBV, HCV and HIV genomes in blood donations: shortcomings of pooling revealed by a multicentre study simulating real-time testing.

This study was undertaken in order to determine whether screening of viremic blood donations by testing of pooled donor samples could constitute a technically feasible transfusional safety measure. A pilot study of real-time simulation, on a day-to-day basis, of screening of three viral genomes (hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV)) was conducted by five French Blood Centers on plasma samples collected from blood donors and studied within undiluted samples and within sample pools of various sizes. This study was carried out within time conditions compatible with the release of platelets. For the detection of HCV and HIV genomes, the five laboratories achieved a sensitivity that decreased with the size of the sample pool. Four were successful in detecting all undiluted samples. In the 1/10 diluted samples, four failed to detect one HIV or HCV sample. In the 1/100 diluted samples, all laboratories failed to detect one or more HIV or HCV samples. For HBV genome, no participating laboratories detected all of the samples of the panel, even undiluted samples, and the sample pooling considerably affected sensitivity. The improvement and standardization of assays needs to be attained, and training of laboratories appears to be a step crucial for routine screening of viral genomes in blood donations.

Blood↗
PubMed1996

A statistical analysis of data on exposure to xylene at selected workplaces in the U.K.

The results of sampling surveys carried out by the Health and Safety Executive (HSE) during 1987-1988 at a random selection of 49 premises, where xylene was used, are reported. A total of 465 personal exposure samples were collected, from which 369 8-h time weighted average (TWA) exposures were calculated. These had a geometric mean (GM) of 2.2 ppm (GSD, +/- 2.9; range, < 1-202 ppm). At that time HSE already had data for personal exposure to xylene in 122 premises collected between 1980 and 1987. These data yielded 511 8-h TWA personal exposures to xylene with a GM of 7.5 ppm (GSD, +/- 4.3; range, < 1-610 ppm). These GMs are significantly different (P < 0.01), suggesting that the pre-existing data were somewhat biased. This is discussed in the context of the use of these data in setting the Occupational Exposure Limits for xylene and the significance to standard setting of any bias in HSE data.

Air Pollutants, Occupational↗
PubMed1992

Control of product batches (before and after registration). The German approach.

At present, batch control is performed after a product is licensed. The range of batch control tests and the detailed description of these tests are fixed for every product during the respective authorization procedure. In an increasing number of cases it also seems necessary to test the prelicensing batches, which are used in the clinical trials for efficacy and safety. The batch control performed in the Paul-Ehrlich-Institute consists of the control of the batch protocols and the practical control of product samples. The practical testing includes purity, efficacy and safety of the batch. Considerable quality differences occur from one batch to another, even when the batch-to-batch-consistency is documented during the authorization procedure. Moreover, without previous indication to the state authority, the authorized control tests are frequently modified by the producer or are not performed for each batch. Some examples of these occurrences are presented. In addition it is necessary to bear in mind that the production of vaccines and sera needs biological seed materials, the quality of which can never be so uniform in the way chemical substances normally are. Since most of the incidents which occur when using vaccines and sera are batch-related and not product-related, the continuous batch control by state authorities is considered to be necessary.

Animals↗
PubMedDate not supplied

[Atomoxetine safety and efficacy in children with attention deficit/hyperactivity disorder (ADHD): initial phase of 10-week treatment in a relapse prevention study with a Spanish sample].

INTRODUCTION: Attention-deficit/hyperactivity disorder (ADHD) appears to be associated to problems with regulation of cortical dopaminergic/noradrenergic function. The purpose of this work is to present efficacy and safety data from 10-week open label treatment with atomoxetine, a highly selective norepinephrine reuptake inhibitor, in a Spanish sample of children and adolescents with ADHD participating in a double-blinded, placebo-controlled, multinational study on relapse prevention. PATIENTS AND METHODS: Sub-analysis of data in 36 children and adolescents aged 6 to 15 years, with diagnosis of ADHD (DSM-IV) included in Spain, receiving open-label treatment with atomoxetine for 10 weeks and assessed using ADHD-RS, CGI-ADHD-S, CPRS-R:S, CTRS-R:S y CHQ-PF50. RESULTS: After 10 weeks of treatment with atomoxetine, statistically significant reductions in ADHD-RS, CGI-ADHD-S, CPRS-R:S and CTRS-R:S scores were obtained in both subtypes; 87.5 % of inattentive patients and 82.14 % of patients with combined subtype were responders. No recurrences were observed. No serious adverse event-driven discontinuations occurred, and no statistically significant changes in blood pressure, but a mild increase in heart rate (p < 0.0001) were observed. CONCLUSIONS: In general, atomoxetine was well tolerated and effective in the open phase in Spanish patients, both for inattentive and combined subtypes. Atomoxetine appears as a non-stimulant therapeutic alternative for the treatment of ADHD.

Adolescent↗
PubMed2000

The role of microbiological testing in systems for assuring the safety of beef.

The use of microbiological testing in systems for assuring the safety of beef was considered at a meeting arranged by the International Livestock Educational Foundation as part of the International Livestock Congress, TX, USA, during February, 2000. The 11 invited participants from industry and government research organizations concurred in concluding that microbiological testing is necessary for the implementation and maintenance of effective Hazard Analysis Critical Control Point (HACCP) systems, which are the only means of assuring the microbiological safety of beef; that microbiological testing for HACCP purposes must involve the enumeration of indicator organisms rather than the detection of pathogens; that the efficacy of process control should be assessed against performance criteria and food safety objectives that refer to the numbers of indicator organisms in product; that sampling procedures should allow indicator organisms to be enumerated at very low numbers; and that food safety objectives and microbiological criteria are better related to variables, rather than attributes sampling plans.

Animals↗
PubMed2006

The safety of central line placement prior to treatment of pediatric acute lymphoblastic leukemia.

BACKGROUND: Central venous lines are placed in children with acute lymphoblastic leukemia at diagnosis, despite significant cytopenias, to facilitate the administration of chemotherapy and blood sampling. The present study aimed to determine the safety of central line placement in these patients. METHODS: We reviewed the charts of 115 consecutive patients treated during a 10-year period. Data abstracted comprised age, gender, presenting and preoperative blood counts, type of central line, blood products transfused preoperatively, duration of neutropenia (absolute neutrophil count [ANC], <500/microl), treatment, and central line-associated complications. RESULTS: There were 66 male and 49 female patients with a median age of 4 years. Seventy-one patients were classified as standard-risk and 44 as high-risk. Respective median blood counts at diagnosis and prior to surgery were white cell count (microl), 4,200 and 5,550; hemoglobin (g/dl), 7.7 and 9.4; platelet count (microl), 63,000 and 72,000; and ANC (microl), 3,950 and 4,900. The median duration of neutropenia was 15 days in the standard-risk group and 18 days in the high-risk group. Thirty-eight patients were not transfused preoperatively. There were no episodes of bacteremia. Seven patients (7%) with life-ports experienced a complication: in four blood could not be aspirated, two ports needed realignment, and one a wound infection developed without dehiscence. Four patients (27%) with external lines had a complication: one each with line occlusion, accidental removal by patient, line rupture, and line leakage at insertion site. The complication rate between ports and external lines was different (P = 0.045). CONCLUSIONS: Central line placement prior to anti-leukemia treatment is safe. Most complications are mechanical and not due to leukemia, chemotherapy, or cytopenias.

Adolescent↗
PubMedDate not supplied

Exposures to quartz, diesel, dust, and welding fumes during heavy and highway construction.

Personal samples for exposure to dust, diesel exhaust, quartz, and welding fume were collected on heavy and highway construction workers. The respirable, thoracic, and inhalable fractions of dust and quartz exposures were estimated from 260 personal impactor samples. Respirable quartz exposures exceeded the National Institute for Occupational Safety and Health (NIOSH) recommended exposure limit (REL) in 7-31% of cases for the trades sampled. More than 50% of the samples in the installation of drop ceilings and wall tiles and concrete finish operations exceeded the NIOSH REL for quartz. Thoracic exposures to quartz and dust exceeded respirable exposures by a factor of 4.5 and 2.8, respectively. Inhalable exposures to quartz and dust exceeded respirable exposures by a factor of 25.6 and 9.3, respectively. These findings are important due to the identification of quartz as a carcinogen by the National Toxicology Program and the International Agency for Research on Cancer. Fourteen percent of the personal samples for EC (n = 261), collected as a marker for diesel exhaust, exceeded the American Conference of Governmental Industrial Hygienists (ACGIH) threshold limit value (TLV) for diesel exhaust. Seventeen of the 22 (77%) samples taken during a partially enclosed welding operation reached or exceeded the ACGIH TLV of 5 mg/m3 for welding fume.

Boston↗
PubMedDate not supplied

Investigations on N-nitrosopyrrolidine in dry-cured bacon.

Dry-cured or "country-style" bacon is a low volume specialty product typically made by small producers whose production practices vary widely. These practices include the direct application of dry-cure formulations containing varying concentrations of salt, sugar, flavoring agents, sodium nitrite, and sometimes sodium nitrate, and the use of lengthy curing and processing times. Because of the possibility of generating higher levels of N-nitrosopyrrolidine (NPYR) after frying in this product type compared with pump-cured bacon, an investigation was carried out on dry-cured bacon obtained from cooperating state or federally inspected establishments. Three different samples from each of the 16 plants were analyzed. Only one sample from each of 2 different producers exceeded the Food Safety and Inspection Service (FSIS) action level of 17 ppb NPYR, indicating that the majority of samples tested were in compliance. A significant correlation (P less than 0.01) was found between residual NaNO2 prior to frying and NPYR after frying. The elimination of added nitrate in the dry-cure formulations is recommended.

Animals↗
PubMed2005

In vitro induction of polyploidy and chromatid exchanges by culture medium extracts of natural rubbers compounded with 2-mercaptobenzothiazole as a positive control candidate for genotoxicity tests.

We tested extracts of custom-made natural rubber samples for cytotoxicity using V79 cells and for chromosome aberration (CA) induction using CHL cells in compliance with the Japanese guidelines for basic biological tests of medical materials and devices. The samples were formulated with a high level of 2-mercaptobenzothiazole (MBT) (A); a low level of MBT (B); or zinc dibutyldithiocarbamate (ZDBC) (C). In the CA test, MBT induced mainly polyploidy, including endoreduplication, and ZDBC induced structural CAs. In the cytotoxicity test, culture medium extracts of A, B, and C suppressed colony formation to 50% of the control value at 53.1%, 94.3%, and >100%, respectively. Culture medium extracts of sample A induced polyploidy and structural CAs in the absence of an exogenous metabolic activation system (S9 mix), but at lower concentrations in its presence, indicating the existence of other leachable promutagens. The extracts of sample B induced structural CAs at the highest concentration and only with S9 mix. Sample C was negative. The facts suggest that sample A may be a candidate for a positive control for genotoxicity tests. The high frequency of polyploidy induced by sample A was not predicted by MBT, suggesting the usefulness of the test for safety evaluation of medical devices. Numerical CAs induced by MBT and sample A are discussed.

Animals↗
PubMed2006

Assessment of airborne asbestos exposure during the servicing and handling of automobile asbestos-containing gaskets.

Five test sessions were conducted to assess asbestos exposure during the removal or installation of asbestos-containing gaskets on vehicles. All testing took place within an operative automotive repair facility involving passenger cars and a pickup truck ranging in vintage from late 1960s through 1970s. A professional mechanic performed all shop work including engine disassembly and reassembly, gasket manipulation and parts cleaning. Bulk sample analysis of removed gaskets through polarized light microscopy (PLM) revealed asbestos fiber concentrations ranging between 0 and 75%. Personal and area air samples were collected and analyzed using National Institute of Occupational Safety Health (NIOSH) methods 7400 [phase contrast microscopy (PCM)] and 7402 [transmission electron microscopy (TEM)]. Among all air samples collected, approximately 21% (n = 11) contained chrysotile fibers. The mean PCM and phase contrast microscopy equivalent (PCME) 8-h time weighted average (TWA) concentrations for these samples were 0.0031 fibers/cubic centimeters (f/cc) and 0.0017 f/cc, respectively. Based on these findings, automobile mechanics who worked with asbestos-containing gaskets may have been exposed to concentrations of airborne asbestos concentrations approximately 100 times lower than the current Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (PEL) of 0.1 f/cc.

Air Pollutants, Occupational↗