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At least 19 recordsLinked to original sources

PubMed1985

Relative bioavailability of chlorthalidone in humans after single oral doses.

The relative bioavailability of chlorthalidone from rapidly dissolving, stabilized, amorphous 15- and 25-mg formulations was compared in 24 normal adult male volunteers to the 25-mg market standard tablet and a 25-mg oral reference solution. When adjusted for dose, the experimental formulations were 116 and 104% of the calculated mean area under the curve for chlorthalidone reference solution compared to 81% for the tablet of the innovator. Likewise, the dose-adjusted mean peak blood levels for the 15- and 25-mg experimental tablets and the 25-mg tablet of the innovator were 112, 105 and 78% of the reference solution, respectively. Mean times-to-peak blood concentrations were 8.4 h for the 25-mg and 9.1 h for the 15-mg amorphous formulations compared to 9.2 h for the oral reference solution and 11.8 h for the market standard tablet. Drug concentrations declined monoexponentially with harmonic mean half-lives ranging from 47 to 55 h and intrinsic clearances ranging from 0.13 to 0.18 L/h regardless of formulation. The dose-adjusted relative bioavailability for the experimental formulations was not significantly different from the oral reference solution, whereas the market standard tablet was significantly (p less than 0.0001) lower than the reference solution. The urinary excretion of chlorthalidone was generally greater following the stabilized amorphous formulations than either the tablet of the innovator or the reference solution. The results of this research show that a rapidly dissolving chlorthalidone tablet can be formulated that shows complete relative bioavailability in humans.

Adult↗

PubMed1991

Multiple peaks and low bioavailability of furosemide correlate with the volume of fluid ingested.

Two different single dose cross-over bioavailability studies were performed comparing a new oral furosemide preparation (test preparation = preparation A) with a marketed standard with a marketed standard preparation (reference preparation = preparation B). Test and reference preparation contained 40 mg of furosemide each. Into both studies, 18 healthy male volunteers were included; 4 volunteers participated in both studies. In study 1, the volunteers ingested the tested preparations together with 300 ml of an electrolyte solution in order to substitute volume and electrolyte deficits. Additional 200 ml were given 30 min post dose, 500 ml during the next 30 min and 1000 ml during the second hour after drug intake. In study 2, the tested preparations were ingested together with 200 ml of water without any additional volume substitution. The plasma concentration curves of study 1 showed a double peaking with a first maximum of furosemide levels at 1 h and a second peak at 3 h and 4 h, respectively, on average. The concentration-time curves of study 2 showed a single peak 1 h p.a. in the mean for both preparations. The relative bioavailability of preparation A was about 67% in study 1 compared to study 2. Preparation B showed a relative bioavailability of 59% in study 1 compared to study 2.

Adult↗

PubMedDate not supplied

Pharmacokinetic evaluation of novel sustained-release dosage forms of valproic acid in humans.

Five new sustained-release dosage forms of valproic acid (VPA) were developed. The new sustained-release formulations were administered to six healthy subjects for comparison with a standard tablet and an i.v. preparation of the drug. Three of the formulations exhibited a more prolonged and uniform absorption rate and yielded more sustained serum levels after ingestion. These three formulations maintained serum therapeutic levels of VPA for 24 h after a single oral administration of 1 g, and were bioequivalent to a marketed standard tablet of VPA. The absorption profile of the various oral formulations was analysed pharmacokinetically, using the Loo-Riegelman procedure.

Administration, Oral↗

PubMedDate not supplied

Relative bioavailability of almitrine bismesylate in humans.

Bioavailability and bioequivalency studies of almitrine bismesylate from U.S. manufactured film coated, waxed, 50 mg tablets were compared in 34 normal healthy volunteers to 50 mg European film coated, waxed and unwaxed, tablets and a 0.5 per cent (w/v) oral reference solution of almitrine bismesylate in d,l malic acid. The U.S. manufactured formulations were 85.88 and 87.85 per cent of the calculated mean area under the individual concentration-time curve for almitrine bismesylate reference solution compared to 88.40 and 88.86 per cent for the waxed and unwaxed film coated European tablets, respectively. The mean peak plasma concentrations for the U.S. formulations were 176.3 ng ml-1 and 180.1 ng ml-1 compared to 196.3 and 200.1 ng ml-1 for the waxed and unwaxed European formulations, respectively. Mean time to peak plasma concentrations for the two U.S. formulations and the waxed and unwaxed European formulations were 3.22, 3.33, 3.06, and 3.26 h, respectively. In addition, the oral reference solution yielded a mean peak plasma concentration of 222.8 ng ml-1 and a mean time to peak plasma concentration of 2.68 h. Analysis of variance and multiple range comparisons (p less than 0.05) indicated that the tablet formulations were bioequivalent. The results of this study show that the U.S. formulated almitrine bismesylate tablets exceed 85 per cent relative bioavailability with respect to the oral reference solution and are bioequivalent compared to the marketed standard European tablet formulations.

Adult↗

PubMed1996

Socioeconomic differences in 'avoidable' mortality in Sweden 1986-1990.

BACKGROUND: 'Avoidable' mortality is commonly studied as an indicator of the outcome of health care. In this study socioeconomic differences in avoidable mortality in Sweden from 1986 to 1990 are analysed and related methodological issues discussed. METHODS: The 1985 Swedish Population and Housing Census was linked to the National Cause of Death Register 1986-1990. Mortality from potentially 'avoidable' causes of death was analysed for the age group 21-64 years. Analyses were performed for different socioeconomic groups, blue-collar workers, white-collar workers and the self-employed as well as for individuals outside the labour market. Standardized Mortality Ratios were calculated using standardization by age and sex. RESULTS: For all indicators studied, the death rates for those not in work were higher than for people at work. The largest differences were found for chronic bronchitis, diabetes, bacterial meningitis, ulcer of the stomach and duodenum, chronic rheumatic heart disease, asthma and hypertensive and cerebrovascular disease. For these causes of death the risk of dying was between 3.1 and 7.5 times greater in the non-working population than in the work-force. The differences in avoidable mortality between blue-collar workers and white-collar workers and the self-employed were, however, much smaller. For most of the indicators no significant differences were found. For ulcers of the stomach and duodenum, however the death rate for blue-collar workers was 2.8 times higher than those for other categories in work. CONCLUSIONS: The small difference in mortality outcome for different socioeconomic groups within the work-force indicates an equal quality of care for these groups. The greatly increased risk among the non-working population, however, is a warning sign. These results may be due to a 'healthy worker' effect. The measurement of socioeconomic differences in mortality may be dependent on the time-period chosen between occupational exposure and mortality outcome.

Adult↗

PubMed2002

[Fatal deception: the tobacco industry's "new" world standards for tobacco marketing].

Being increasingly threatened by the worldwide antismoking struggle, the major tobacco companies are eager to improve their public image. This leads the companies to adopt inconsequential "measures" such as the tobacco industry's "new" standards for tobacco marketing that were "voluntarily" issued in September 2001 by the British American Tobacco company. These measures are clearly attempts to reduce the disapproval generated by the companies' promotion and advertising campaigns, which indirectly target young people. With these standards the tobacco companies supposedly commit themselves, among other things, to not using advertising directed at youth and to not selling or distributing tobacco products in places frequented by young people. This document explains why these measures are completely ineffective, are not anything new, and are a subtle effort to feign a conscientious, responsible attitude, which is far from genuine. As long as there are marketing activities directed at adults, young people will be exposed to the influence of those activities. Many countries have completely prohibited the marketing of tobacco products, given that the "new" marketing standards do not represent progress in any way whatsoever.

Advertising↗

PubMedDate not supplied

The SGML standardization framework and the introduction of XML.

Extensible Markup Language (XML) is on its way to becoming a global standard for the representation, exchange, and presentation of information on the World Wide Web (WWW). More than that, XML is creating a standardization framework, in terms of an open network of meta-standards and mediators that allows for the definition of further conventions and agreements in specific business domains. Such an approach is particularly needed in the healthcare domain; XML promises to especially suit the particularities of patient records and their lifelong storage, retrieval, and exchange. At a time when change rather than steadiness is becoming the faithful feature of our society, standardization frameworks which support a diversified growth of specifications that are appropriate to the actual needs of the users are becoming more and more important; and efforts should be made to encourage this new attempt at standardization to grow in a fruitful direction. Thus, the introduction of XML reflects a standardization process which is neither exclusively based on an acknowledged standardization authority, nor a pure market standard. Instead, a consortium of companies, academic institutions, and public bodies has agreed on a common recommendation based on an existing standardization framework. The consortium's process of agreeing to a standardization framework will doubtlessly be successful in the case of XML, and it is suggested that it should be considered as a generic model for standardization processes in the future.

Cohort Studies↗

PubMed1999

Effects of sire growth potential, growing-finishing strategy, and time on feed on performance, composition, and efficiency of steers.

Beef production systems that increase use of unharvested forages and use animals with greater potential for gain affect age and size of animals placed on a finishing regimen. This experiment was conducted to evaluate effects of genetic potential for gain, age at the start of a finishing period, and time on feed on composition, quantity, and quality of beef produced and efficiency of production during finishing. Crossbred cows were bred by AI to Charolais or Line 1 Hereford bulls that represented potentially high (HG) or moderate growth (MG) rates, respectively, to produce spring- or fall-born calves. Steer calves from these matings were placed on an individually fed finishing diet at three ages (A). Spring-born steers were started at 6 or 18 mo of age (A6 and A18), and fall-born steers were started at 12 mo of age (A12). Slaughter times (T) were at 0, 90, 180, and 270 d for A6; 68, 136, and 204 d for A12; and 0, 45, 90, and 135 d for A18. Data collected on each animal included feed intake, growth, chemical composition of the complete body and carcass, and quantitative and qualitative assessment of the meat produced. Four steers of each sire group were slaughtered in each of the 11 A-T treatment groups, and the experiment was repeated for 2 yr in the A12 groups and 3 yr in the A6 and A18 groups (n = 237). Steers sired by HG bulls were larger and produced larger carcasses and more carcass protein than MG-sired steers (S, P < .05 or .01). Steers sired by MG bulls were fatter, had higher quality grades, and accumulated fat at a faster rate than HG-sired steers, and this effect was greater in older steers (G and GA, P < .05 or .01). Sire growth potential did not affect gain, intake, live weight efficiency, tenderness, or taste panel scores (P > .2). Steers sired by HG bulls were more efficient at producing carcass weight and carcass protein at A12 and A18 than were MG-sired steers. At the end of the finishing period, older (A18), HG-sired steers were too large with insufficient fat by current industry standards, and younger (A6), MG-sired steers were too small. Our conclusions are that both HG- and MG-sired steers can produce acceptable carcasses for current market standards with comparable efficiencies of live-weight gain, but the growing and finishing strategy must be adapted to the genotype.

Animal Feed↗

PubMed1991

Facsimile (fax) technology.

Fax technology is the transmission of text and graphic data between two locations via telephone lines. The advantages of this technology include the speed with which a document can be sent anywhere in the world and the decreased cost versus traditional courier and Telex services. Several different types of machines exist, but standard operating parameters are set by the Consultative Committee for International Telephone and Telegraph (CCITT). There are four categories of machines, called Groups, which aid in classifying the various fax units. Group 3 machines are the most common comprising about 75% of the market. Standard features vary between and within groups, depending on the manufacturer and model. Features such as polling, document broadcasting, security levels, and computer linkage are discussed. The healthcare industry has been slow to adopt fax technology. Applications in hospital pharmacy are the main focus of attention of some hospital administrators and directors of pharmacy. A few studies have shown decreased medication order turnaround time after implementation of a fax-based pharmacy order system. However, problems such as order clarity and legibility, elevated nursing expectations and increased use of paper can decrease its usefulness. Overall, facsimile technology will find a place in the healthcare arena and may become an integral part of the modern pharmacy department.

Copying Processes↗

PubMedDate not supplied

Judo strategy. The competitive dynamics of Internet time.

Competition on the Internet is creating fierce battles between industry giants and small-scale start-ups. Smart start-ups can avoid those conflicts by moving quickly to uncontested ground and, when that's no longer possible, turning dominant players' strengths against them. The authors call this competitive approach judo strategy. They use the Netscape-Microsoft battles to illustrate the three main principles of judo strategy: rapid movement, flexibility, and leverage. In the early part of the browser wars, for instance, Netscape applied the principle of rapid movement by being the first company to offer a free stand-alone browser. This allowed Netscape to build market share fast and to set the market standard. Flexibility became a critical factor later in the browser wars. In December 1995, when Microsoft announced that it would "embrace and extend" competitors' Internet successes, Netscape failed to give way in the face of superior strength. Instead it squared off against Microsoft and even turned down numerous opportunities to craft deep partnerships with other companies. The result was that Netscape lost deal after deal when competing with Microsoft for common distribution channels. Netscape applied the principle of leverage by using Microsoft's strengths against it. Taking advantage of Microsoft's determination to convert the world to Windows or Windows NT, Netscape made its software compatible with existing UNIX systems. While it is true that these principles can't replace basic execution, say the authors, without speed, flexibility, and leverage, very few companies can compete successfully on Internet time.

Economic Competition↗

PubMed1999

[Is vocational integration in the competitive labor market a realistic goal for the chronically mentally ill?].

A wide range of sheltered jobs has been created in the second or special labour market with the aim of enabling the chronically mentally ill to participate in working life. However, having a job in the special labour market often precludes the chance of obtain-ing employment in the competitive labour market. To date, vocational integration programs enable only a small number of persons with psychiatric disabilities to attain reintegration into competitive employment. The predictors of successful vocational integration are subsequently discussed. A substantial increase in both sheltered and competitive jobs on the common labour market could be achieved for mentally ill and disabled people by adapting the "supported employment" model, as widely practised in the USA, to European labour market standards and appropriately funding its implementation. The utilisation of this model could serve to reduce the necessity of further expansion in the special labour market.

Employment↗

PubMedDate not supplied

Comparison of two microemulsion of cyclosporine A in healthy volunteers.

This study evaluated the bioequivalence of a new Cyclosporine A microemulsion formulation in comparison to the reference market standard. Twenty-four adult healthy volunteers were randomised to receive the two Cyclosporin A microemulsion formulations, at a dose of 2.5 mg/kg, according to a cross-over design. Blood samples were taken before drug administration and at 12 points within 24 hours. Cyclosporine A whole blood concentrations were determined by HPLC. The pharmacokinetic parameters AUC0-t and AUC0-infinity were calculated by the trapezoidal rule, Cmax and Tmax were obtained directly from blood data. AUCs and Cmax were tested for bioequivalence after log transformation of data, differences for Tmax were evaluated by the rank test of Wilcoxon for paired data. The 90% confidence interval ratio between tested/reference drug was 0.98 for AUC0-t, 0.96 for AUC0-infinity and 1.01 for Cmax. All of them were within the range of bioequivalence. Tmax was 1.60 +/- 0.44 hours after test drug and 1.67 +/- 0.48 after reference drug (p = 0.27, Wilcoxon test). According to these results the two Cyclosporine A microemulsion formulations can be considered bioequivalent.

Adult↗

PubMed1989

Bioequivalence and pharmacodynamics of a modified glibenclamide formulation in healthy volunteers.

A glibenclamide preparation (Glycolande N) with a modified galenic formulation was compared with a marketed standard preparation for bioequivalence and hypoglycaemic action after single oral administration of 3.5 mg. Twelve healthy male volunteers participated in this open two-way cross-over study. The confidence intervals around the mean values of the standard preparation were all in the range of +/- 20%. No significant differences were found between both formulations for Cmax, Tmax, AUC1 and AUC3. The glucose profiles were virtually equal. Both preparations are regarded as bioequivalent and therapeutically equivalent.

Adult↗

PubMed1985