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Kinds of Manufacturers Terms modified by Manufacturers Selected AbstractsSafety, effectiveness and comparability of professional skin cleansersJOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, Issue 10 2010Flora K. Terhaer Summary Background: There are no widely-accepted methodical specifications with which to objectify cleansing effectiveness and skin compatibility of occuptional skin cleansing products in Europe. Therefore the German Social Insurance Agency (DGUV) initiated a study with the goal to evaluate such products in view of the potency and the safety of hand cleansers. A market analysis was a part of the project. Methodology: The product descriptions and safety data sheets of 120 products (5,20/manufacturer) of 11 manufacturers were evaluated between 02/2008 and 04/2008. Results: The manufacturers used mainly ingredients of low irritancy. The declaration of the applied ingredients was in the majority of the cases correctly labeled according to the INCI Declaration. Although there was documentation of skin tolerability for most products, the manufacturers used widely differing tests of skin compatibility. Evidences for cleansing effectiveness were not declared or have not been provided. One manufacturer even promised medical effects of its products. There was no uniform general classification of products making it difficult to identify characteristics of cleansers and choose between them. Conclusions: Presently, there are no commonly accepted criteria to classify products in view of cleansing effectiveness und skin compatibility. Generally accepted criteria and test methods are needed for the evaluation of hand cleansers in order to provide the possibility of transparency and comparability. [source] Multicenter Study of the Safety and Efficacy of a 585 nm Pulsed-Dye Laser for the Nonablative Treatment of Facial RhytidesDERMATOLOGIC SURGERY, Issue 1 2005T. S. Jeffrey Hsu MD Objective The objective of this study was to assess the safety and efficacy of a 585 nm flashlamp pulsed-dye laser for the nonablative treatment of facial rhytides. Methods A multicenter prospective randomized controlled study on 58 volunteers was performed. A split-face approach was adopted, with one periorbital region acting as a control and the other receiving either one or two treatments. Patients were photographed and imaged three-dimensionally before and after treatment. Histologic sections were analyzed. Results Three-dimensional topographic evaluation showed improvements of 9.8% (p= .0022) and 15% (p= .0029) in surface roughness for single and double treatments, respectively. Histology revealed an increase in type I collagen messenger ribonucleic acid expression, type III procollagen, chondroitin sulfate, and grenz zone thickness. Two treatments resulted in greater improvement than one treatment. Conclusion Clinical improvement was achieved following a single treatment. Further improvement was observed following a second treatment. The subjective evaluation of clinical improvement was consistent with both histologic and topographic quantitative measurements. SUZANNE KILMER, MD, AND JAY BURNS, MD, RECEIVED THE USE OF THE LASER FOR RESEARCH AND A DISCOUNTED PURCHASE AGREEMENT. THEY BOTH ACKNOWLEDGE RECEIVING HONORARIA FOR LECTURING FROM THE MANUFACTURER. BRIAN ZELICKSON, MD, RECEIVED RESEARCH GRANTS FROM ICN. [source] Channel Coordination for a Supply Chain with a Risk-Neutral Manufacturer and a Loss-Averse Retailer,DECISION SCIENCES, Issue 3 2007Charles X. Wang ABSTRACT This articles considers a decentralized supply chain in which a single manufacturer is selling a perishable product to a single retailer facing uncertain demand. It differs from traditional supply chain contract models in two ways. First, while traditional supply chain models are based on risk neutrality, this article takes the viewpoint of behavioral principal,agency theory and assumes the manufacturer is risk neutral and the retailer is loss averse. Second, while gain/loss (GL) sharing is common in practice, there is a lack of analysis of GL-sharing contracts in the supply chain contract literature. This article investigates the role of a GL-sharing provision for mitigating the loss-aversion effect, which drives down the retailer order quantity and total supply chain profit. We analyze contracts that include GL-sharing-and-buyback (GLB) credit provisions as well as the special cases of GL contracts and buyback contracts. Our analytical and numerical results lend insight into how a manufacturer can design a contract to improve total supply chain, manufacturer, and retailer performance. In particular, we show that there exists a special class of distribution-free GLB contracts that can coordinate the supply chain and arbitrarily allocate the expected supply chain profit between the manufacturer and retailer; in contrast with other contracts, the parameter values for contracts in this class do not depend on the probability distribution of market demand. This feature is meaningful in practice because (i) the probability distribution of demand faced by a retailer is typically unknown by the manufacturer and (ii) a manufacturer can offer the same contract to multiple noncompeting retailers that differ by demand distribution and still coordinate the supply chains. [source] Impact of deposit ageing on thermal fouling: Lumped parameter modelAICHE JOURNAL, Issue 2 2010Edward. Abstract The thermal and hydraulic performance of heat exchangers can be seriously impaired by the formation of fouling deposits on the heat transfer surfaces. The thermal effect of fouling can be complicated when the deposit is subject to ageing, represented here as a change in deposit thermal conductivity (but not thickness) over time. In this article, we revisit the ageing concept for crude oil fouling proposed by Nelson (Refiner Nat Gas Manufacturer. 1934;13:271,276, 292,298), using a numerical model incorporating first order kinetics to generate quantitative comparisons of different ageing rates. Results are reported for lumped parameter systems (which also simulate point measurement methods commonly used in laboratory testing) that demonstrate that ageing can have a substantial influence on the rate of heat transfer and hence on the surface temperature and rate of fouling. Rapid ageing (compared with the rate of deposition) does not pose problems, but slow ageing, or the use of constant heat fluxes in experiments, can lead to modified thermal fouling behavior. It is concluded that deposit ageing dynamics should be considered alongside deposition rate dynamics when interpreting experimental fouling data and when modeling fouling behavior in support of heat exchanger design or operation. © 2009 American Institute of Chemical Engineers AIChE J, 2010 [source] Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical OverstressPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 7 2001ROBERT G. HAUSER Hauser, R., et al.: Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress. Because it is a lifesaving device, the unexpected failure of an ICD can be catastrophic. We report ICD electronic circuit failure due to electrical overstress damage (EOS) to the high voltage hybrid circuit and other electronic components in a series of ICD pulse generator models. Data were obtained from the Multicenter Registry of Pacemaker and ICD Pacemaker and Lead Failures, and from the manufacturers' adverse event reports, that were in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Of 16 nonbattery Guidant/CPI ICD pulse generator failures reported to the registry, 6 (38%) have been confirmed by the manufacturer to be EOS related, and Guidant/CPI has reported 273 such failures to the FDA as of 12/29/00. The signs of failure included loss of telemetry and inability to deliver therapy, and some patients have experienced serious adverse events. Hybrid circuit damage may have occurred during capacitor charging or reform, and the majority appears to have happened during normal ICD function. While the incidence of this problem is unknown, a management strategy should be adopted that includes routine follow-up every 3 months and device evaluation after a shock or exposure to external defibrillation or electrosurgical devices. This study suggests that additional data are needed to determine the incidence of this problem, and that our present methods for monitoring the performance of ICDs following market release are inadequate. [source] Implementing Evaluation of the Measurement Process in an Automotive Manufacturer: a Case StudyQUALITY AND RELIABILITY ENGINEERING INTERNATIONAL, Issue 5 2003Graeme Knowles Abstract Reducing process variability is presently an area of much interest in manufacturing organizations. Programmes such as Six Sigma robustly link the financial performance of the organization to the degree of variability present in the processes and products of the organization. Data, and hence measurement processes, play an important part in driving such programmes and in making key manufacturing decisions. In many organizations, however, little thought is given to the quality of the data generated by such measurement processes. By using potentially flawed data in making fundamental manufacturing decisions, the quality of the decision-making process is undermined and, potentially, significant costs are incurred. Research in this area is sparse and has concentrated on the technicalities of the methodologies available to assess measurement process capability. Little work has been done on how to operationalize such activities to give maximum benefit. From the perspective of one automotive company, this paper briefly reviews the approaches presently available to assess the quality of data and develops a practical approach, which is based on an existing technical methodology and incorporates simple continuous improvement tools within a framework which facilitates appropriate improvement actions for each process assessed. A case study demonstrates the framework and shows it to be sound, generalizable and highly supportive of continuous improvement goals. Copyright © 2003 John Wiley & Sons, Ltd. [source] Supply Chain Strategy, Product Characteristics, and Performance Impact: Evidence from Chinese Manufacturers,DECISION SCIENCES, Issue 4 2009Yinan Qi ABSTRACT Supply chain management has become one of the most popular approaches to enhance the global competitiveness of business corporations today. Firms must have clear strategic thinking in order to effectively organize such complicated activities, resources, communications, and processes. An emerging body of literature offers a framework that identifies three kinds of supply chain strategies: lean strategy, agile strategy, and lean/agile strategy based on in-depth case studies. Extant research also suggests that supply chain strategies must be matched with product characteristics in order for firms to achieve better performance. This article investigates supply chain strategies and empirically tests the supply chain strategy model that posits lean, agile, and lean/agile approaches using data collected from 604 manufacturing firms in China. Cluster analyses of the data indicate that Chinese firms are adopting a variation of lean, agile, and lean/agile supply chain strategies identified in the western literature. However, the data reveal that some firms have a traditional strategy that does not emphasize either lean or agile principles. These firms perform worse than firms that have a strategy focused on lean, agile, or lean/agile supply chain. The strategies are examined with respect to product characteristics and financial and operational performance. The article makes significant contributions to the supply chain management literature by examining the supply chain strategies used by Chinese firms. In addition, this work empirically tests the applicability of supply chain strategy models that have not been rigorously tested empirically or in the fast-growing Chinese economy. [source] Pathogen safety of manufacturing processes for biological products: special emphasis on KOGENATE® BayerHAEMOPHILIA, Issue 2002D. C. Lee Summary., Manufacturers of human therapeutic proteins derived from biological sources continuously strive to improve the pathogen safety profiles of these products. Efforts to improve pathogen safety margins for these biological products are directed towards several areas within the manufacturing processes including: (a) sourcing and screening of raw materials (b) determining the potential for manufacturing processes to reduce pathogen titres, and (c) incorporating methods designed specifically to remove or inactivate contaminating pathogens. Methods that could potentially reduce pathogen titres are a major focus for many manufacturers. In general, these methods are grouped into two categories, pathogen clearance and pathogen inactivation. Assessments are performed on small-scale, laboratory simulations of the manufacturing process of interest that are spiked with a known amount of a selected pathogen. These studies provide estimates of the potential for a process step to remove or inactivate a particular pathogen. There are several pathogen clearance/inactivation methods that are inherent in manufacturing processes, however, some methods are intentionally incorporated into manufacturing for the sole purpose of reducing putative pathogen titres. Not only are well-known pathogens such as viruses targeted, but also suspected pathogens such as those associated with the transmissible spongiform encephalopathies (TSEs). The production processes for the isolation of several biological products, including recombinant KOGENATE® Bayer (Kogenate®FS), have been evaluated for the ability to reduce pathogen titres and/or have been designed to incorporate methods for reducing potential pathogen safety risks. Several processing steps with the potential to reduce pathogen titres have been identified. [source] Venous needle dislodgement during hemodialysis: An unresolved risk of catastrophic hemorrhageHEMODIALYSIS INTERNATIONAL, Issue 1 2005S. Sandroni Venous line disconnection or needle dislodgement during hemodialysis with resultant hemorrhage is a potentially lethal event. The risk is compounded by the frequent failure of standard dialysis machines to detect the event, as blood flow through the venous needle typically creates enough back pressure to prevent venous pressure alarms even if the needle is completely out of the patient's AV access. Manufacturers are well aware of the risk and device literature contains specific warnings about it. The FDA publishes reports on its website about these events; so far this year there have been seven reported events with five deaths. Informal sources indicate that the actual (unreported) occurrence is much more frequent; we are aware of four additional events within our region alone. Efforts to reduce the risk include protocols requiring the access needles to always be visible, and use of enuresis detection devices. Anecdotal experience with these efforts suggests they are not highly effective. Protocols requiring documentation of more frequent needle site checks or alternate methods of securing the needles have not been formally evaluated. However, such efforts do not address the primary problem: there is a need for an engineered solution to this problem. Requirements for such a solution include: reliable detection of needle position and blood flow discrepancies, a useful alarm, and feedback to stop the blood pump. Persistence of this problem raises issues of regulatory oversight. [source] Strategic Groups of EU Food ManufacturersJOURNAL OF AGRICULTURAL ECONOMICS, Issue 1 2000W. Bruce Traill Strategic groups of food manufacturers are derived using factor and cluster analysis applied to a survey of European food manufacturers. The aim is to obtain groupings of businesses that are meaningful for industry and policy analysis. Eight strategic groups are derived and profiled. The sources of competitive advantage of the businesses in the eight groups are assessed in relation to expected developments in the European food industry and the implications for industry and policy analysis are introduced. For example, businesses that have developed competencies in international sales linked either to product or process innovation appear better placed than those relying on local or national brand strategies. Countries with a large share of the former types of firms (e.g., Denmark) are better placed than countries with a large share of the latter types (e.g., Finland). [source] Deaths Between Bedrails and Air Pressure MattressesJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2002Steven H. Miles MD OBJECTIVES: To describe how patients die by becoming trapped between therapeutic air pressure mattresses and bed rails. DESIGN: A retrospective review of all voluntary reports deaths in beds with air mattresses that can be found in the Food and Drug Administration's on-line databases of adverse medical events that cover 1994 to 2001. SETTING: Death reports come from manufacturers, medical staff, and coroners and describe deaths in hospitals, nursing homes, and home care, although type of care site is often not given. MEASUREMENTS: Event descriptions were reviewed to determine how the person became entrapped in the rail and how responsibility for the event was allocated. RESULTS: There were 35 deaths involving many product lines. Twenty-one deaths involved overlay air mattresses placed on top of a regular mattress. Thirteen patients died in beds with built-in air mattresses. Compression of the mattress allowed an off-center person to slide against the rail where reexpansion of the mattress kept the person compressed against the rail. Two patterns were seen. In one, the mattress bunched up behind a person who was lying on the side of the bed, pushing the neck against a bedrail. In the second type, a patient died after sliding off the bed and having the neck or chest compressed between the rail and bed. Manufacturers attributed the deaths to poor clinical decision-making or inadequate monitoring. CONCLUSIONS: Lethal asphyxiation in beds with air pressure mattresses is a variant of bedrail-mattress entrapment that requires redesign by bed manufacturers and risk awareness by clinicians. [source] PHYSICOCHEMICAL AND FLAVOR CHANGES OF FRAGRANT BANANA (MUSA ACUMINATA AAA GROUP "GROSS MICHEL") DURING RIPENINGJOURNAL OF FOOD PROCESSING AND PRESERVATION, Issue 3 2010SOMRUEDEE THAIPHANIT ABSTRACT The objective of this research was to characterize the physicochemical and flavor changes that occur in ripe Hom Thong (Musa acuminata AAA Group "Gross Michel") flesh at stage 6,8. It was found that the higher fresh maturity stage of Hom Thong at P < 0.05 has the following results: the antioxidant activities, moisture content and reducing sugar are significantly increased. The titratable acidity, total soluble solid and prebiotic activities' score for Lactobacillus acidophilus LA5 and Bifidobacterium lactis BB-12 are significantly decreased. The total dietary fiber remains unchanged. Using headspace solid-phase microextraction and gas chromatography,mass spectrometry to characterize volatile compound found that the flavor 20 volatile compounds (11 esters, 5 alcohols, 3 carbonyls and 1 ketone) are varied on Hom Thong maturity stage. The compounds with the most aroma impact for ripe Hom Thong flesh at stage 6,8 were 3-methylbutyl butanoate, 3-methyl-1-butyl acetate, 3-methylbutyl 3-methylbutanoate and 2-methylpropyl ethanoate. PRACTICAL APPLICATIONS Ripe banana Musa acuminata, AAA Group "Gross Michel," locally known in Thailand as Hom Thong, is a popular food item consumed as fruit, snacks or food ingredients for confections, spreads and other banana products. Using a suitable ripening stage of the banana flesh is the most critical step among many steps of unit operations for achieving high-quality banana products. This study not only characterizes the physicochemical and flavor changes that occur in ripe Hom Thong flesh at stage 6,8, but also studies antioxidant activities and prebiotic activities. Manufacturers can utilize the data presented in this article to select the suitable ripening stage in order to avoid product failure and to produce the best quality products for functional food, pharmafood, medifood or vitafood that are rich in natural banana flavor. [source] OPTIMAL COAGULANT CONCENTRATION, SOYMILK AND TOFU QUALITY AS AFFECTED BY A SHORT-TERM MODEL STORAGE OF PROTO SOYBEANSJOURNAL OF FOOD PROCESSING AND PRESERVATION, Issue 1 2008ZHI-SHENG LIU ABSTRACT Soybeans were adjusted to water activities (Aw) from 0.60 to 0.81, and stored at 30C for up to 3 months. At 1-month intervals, soybeans were retrieved from the storage and processed into 10.5 Brix soymilk. The optimal coagulant concentration (OCC) for making filled tofu was determined using a titration method. Other soymilk characteristics, including total solids, protein, 11 S/7 S protein ratio, phytate, titratable acidity, pH and color, were also determined. Filled tofu was prepared from each stored soybeans with the respective OCC using MgCl2 or CaCl2. With increasing Aw or storage time, the OCC decreased significantly. The decrease in OCC was significantly correlated to the difference in soymilk titratable acidity and the change in soymilk pH. Soybean storage time slightly decreased the breaking stress and apparent Young's modulus of the filled tofu, particularly the MgCl2 coagulated tofu. With increasing Aw or storage time, the lightness and yellowness intensity of both soymilk and tofu decreased, whereas their redness intensity increased. PRACTICAL APPLICATIONS Tofu and soymilk are popular soybean foods. Using optimal concentration of coagulant in soymilk is the most critical step among many steps of unit operations during tofu manufacturing for achieving high quality tofu. Improper use of coagulant can lead to product failure and therefore significant economic loss for the manufacturers. The optimal coagulant concentration varies not only with processing condition, but also with soybean materials which are affected by variety and storage conditions. Acidity, pH and food color are important quality factors to influence taste and consumer acceptance. Soybeans are subject to storage and transportation before processing. Storage length and environmental humidity are two of important factors which affect soybean quality and processing property. This study provides very important information that is useful for the soymilk and tofu manufacturers in controlling product quality through the understanding of the chemistry and processing characteristics of stored soybeans. Manufacturers can utilize the methods presented in this article to calculate the optimal coagulant concentrations to avoid product failure and to produce the best quality products. [source] Role of Orthopedic Implants and Bone Morphology in the Identification of Human RemainsJOURNAL OF FORENSIC SCIENCES, Issue 2 2007Ellie K. Simpson Ph.D. ABSTRACT: When conventional methods of identification, such as visual recognition and dental comparison, cannot be used to identify a deceased person, it becomes necessary to consider alternative methods. The presence of an orthopedic implant in a body may assist identification if ante-mortem medical records are available for comparison. Another method of identification involves comparison of ante-mortem and postmortem radiographs. Eight cases are reported from Forensic Science SA where the presence of orthopedic implants and/or ante-mortem radiographs were used to try to establish identification. In six cases, positive identification was established, and in two cases with upper limb orthopedic implants, the bones remained unidentified. Manufacturers were unable to provide any information about the distribution and use of the implants that could be of use with identification, as there are no requirements in Australia for individual medical implants to be tracked. Such a system has the potential to aid postmortem identification if serial codes were etched onto implants that could then be traced to manufacturers, surgeons, and recipients of these devices. [source] EFFECTS OF BITE SIZE ON THE SENSORY PROPERTIES OF VANILLA CUSTARD DESSERTSJOURNAL OF SENSORY STUDIES, Issue 3 2007JON F. PRINZ ABSTRACT A trained panel of 19 subjects were asked to rate a number of sensory attributes of commercially available vanilla custard desserts. Stimuli were placed in plastic cups and were sampled using 11-mm-diameter straws. In total, 304 samples were weighed before and after sampling and the volume ingested was calculated. The subjects were categorized into two groups on the basis of the mean volume ingested per sample (< and >10.6 mL). There were significant differences in the ratings between the two groups for temperature, creamy, astringent, melting and airy mouthfeels and rough and fatty after-feel. We suggest that in sensory testing, it is important to either control or measure bite size to reduce intersubject variability. Manufacturers and caterers may also be able to modify the perception of their products by providing cues to the appropriate bite size by controlling the size of the spoon or container provided. [source] Technological Scanning by Small Canadian ManufacturersJOURNAL OF SMALL BUSINESS MANAGEMENT, Issue 2 2001Louis Raymond Given that in many industries new production and information technologies have fundamentally changed the way in which firms must operate and compete, the technological aspect of environmental scanning has become a critical success factor for many small and medium-sized manufacturing enterprises. As little is presently known about how technological scanning manifests itself in these organizations and about what determines the nature and level of this activity, a survey study of 324 Canadian firms was done. Testing a research model resulted in identifying four interrelated dimensions of scanning activity, namely scanning objectives, type of information, information sources, and management practices. Key determinants of this activity were also identified, including the firms' strategy, environmental uncertainty, production technology, level of R&D, information networks, and the owner-manager's education level. [source] SUPPLIER INNOVATIVENESS AND THE ROLE OF INTERORGANIZATIONAL LEARNING IN ENHANCING MANUFACTURER CAPABILITIESJOURNAL OF SUPPLY CHAIN MANAGEMENT, Issue 4 2008ARASH AZADEGAN Manufacturers increasingly rely on innovation from their suppliers to improve the cost, quality, and timeliness of their products. Manufacturing capabilities are enhanced by supplier innovativeness directly, because of the embedded nature of the supplied component, and indirectly, as the manufacturer learns from its suppliers. We use organizational learning theory to develop a conceptual model of learning factors that act as contingencies and magnify the effect of supplier innovativeness. First, we argue that a manufacturer's absorptive capacity, its ability to learn and use external knowledge, positively moderates the impact of supplier innovativeness on the manufacturer's performance. Second, we examine how different combinations of manufacturer,supplier learning styles lead to relatively more or less interorganizational learning, contingent upon whether the outsourcing is design versus manufacturing oriented. Our model can help managers consider knowledge transfer as part of their supplier selection criteria. [source] The Privatization of Public Legal Rights: How Manufacturers Construct the Meaning of Consumer LawLAW & SOCIETY REVIEW, Issue 3 2009Shauhin A. Talesh This article demonstrates how the content and meaning of California's consumer protection laws were shaped by automobile manufacturers, the very group these laws were designed to regulate. My analysis draws on and links two literatures that examine the relationship between law and organizations but often overlook one another: political science studies of how businesses influence public legal institutions, and neo-institutional sociology studies of how organizations shape law within their organizational field. By integrating these literatures, I develop an "institutional-political" theory that demonstrates how organizations' construction of law and compliance within an organizational field shapes the meaning of law among legislators and judges. This study examines case law and more than 35 years of California legislative history concerning its consumer warranty laws. Using institutional and political analysis, I show how auto manufacturers, who were initially subject to powerful consumer protection laws, weakened the impact of these laws by creating dispute resolution venues. The legislature and courts subsequently incorporated private dispute resolution venues into statutes and court decisions and made consumer rights and remedies largely contingent on consumers first using manufacturer-sponsored venues. Organizational venue creation resulted in public legal rights being redefined and controlled by private organizations. [source] Variability in Implantable Cardioverter Defibrillator Pulse Generator Longevity Between ManufacturersPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 1p1 2003PATRICK T. ELLINOR ELLINOR, P.T., et al.: Variability in Implantable Cardioverter Defibrillator Pulse Generator Longevity Between Manufacturers.ICDs are used frequently to treat malignant ventricular arrhythmias. Despite the expanding role of these devices, little is known about the manufacturer variability in the performance of ICD generators. The purpose of this study is to explore the indications for ICD pulse generator replacement and to examine performance differences between the three major manufacturers of ICDs in the United States. The authors performed a retrospective review of ICD pulse generators that were implanted and replaced at Massachusetts General Hospital between February 1998 and March 2002. During the study period, 50 (7%) of the 707 devices in the study cohort were replaced. The most common indication for pulse generator replacement was related to battery performance followed by device recall, upgrade to a dual chamber device, and pulse generator malfunction. After exclusion of the recalled devices, a significantly higher number of pulse generators manufactured by St. Jude Medical (14/229) required replacement for battery depletion or prolonged charge times during the study period compared with devices from Guidant (2/220) or Medtronic (0/273),P = 0.003andP < 0.0001, respectively. This difference was attributable to reduced longevity in the Angstrom series of defibrillators. (PACE 2003; 26[Pt. I]:71,75) [source] Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980,1999,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2002James Cross MS Abstract Purpose Risks and benefits of marketed drugs can be improved by changing their labels to optimize dosage regimens for indicated populations. Such postmarketing label changes may reflect the quality of pre-marketing development, regulatory review, and postmarketing surveillance. We documented dosage changes of FDA-approved new molecular entities (NMEs), and investigated trends over time and across therapeutic groups, on the premise that improved drug development methods have yielded fewer postmarketing label changes over time. Methods We compiled a list of NMEs approved by FDA from 1 January 1980 to 31 December 1999 using FDA's website, Freedom of Information Act request, and PhRMA (Pharmaceutical Research and Manufacturers of America) database. Original labeled dosages and indicated patient populations were tracked in labels in the Physician's Desk Reference®. Time and covariate-adjusted risks for dosage changes by 5-year epoch and therapeutic groups were estimated by survival analysis. Results Of 499 NMEs, 354 (71%) were evaluable. Dosage changes in indicated populations occurred in 73 NMEs (21%). A total of 58 (79%) were safety-motivated, net dosage decreases. Percentage of NMEs with changes by therapeutic group ranged from 27.3% for neuropharmacologic drugs to 13.6% for miscellaneous drugs. Median time to change following approval fell from 6.5 years (1980,1984) to 2.0 years (1995,1999). Contrary to our premise, 1995,1999 NMEs were 3.15 times more likely to change in comparison to 1980,1984 NMEs (p,=,0.008, Cox analysis). Conclusions Dosages of one in five NMEs changed, four in five changes were safety reductions. Increasing frequency of changes, independent of therapeutic group, may reflect intensified postmarketing surveillance and underscores the need to improve pre-marketing optimization of dosage and indicated population. Copyright © 2002 John Wiley & Sons, Ltd. [source] Reduction of the UV burden to indoor tanners through new exposure schedules: a pilot studyPHOTODERMATOLOGY, PHOTOIMMUNOLOGY & PHOTOMEDICINE, Issue 2 2006Sharon A. Miller Background: The development of new pigmentation (tan) in human skin after UV exposure requires several days. Once it is developed, the tan can last for weeks. Current recommendations for tanning exposure schedules in the USA (FDA Letter to Manufacturers: Policy on maximum timer interval and exposure schedule for sunlamps, August 21, 1986) allow exposures three times per week for the development of a tan, and one to two times per week for maintenance exposures. However, this policy is often interpreted in the indoor tanning industry as allowing three exposures per week on a continuous basis. We believe that the reduction of the recommended cumulative dose to indoor tanners should be explored. Two approaches for achieving this are (1) decreasing the number of exposures and (2) increasing the time interval between exposures. To explore such changes, we conducted a pilot study. Methods: The pilot study involved three exposure schedules (evaluated on each of six subjects) that evolved throughout the course of the study. Digital photography, visual assessment and diffuse reflectance spectrometry were used to assess skin color changes. The six pilot subjects were studied for 8,18 weeks. The changes in skin color obtained through the use of the different exposure schedules were compared with changes reported by Caswell (Caswell M, The kinetics of the tanning response to tanning bed exposures, Photodermatol Photoimmunol Photomed 2000: 16: 10,14) who used schedules based on current recommendations. Results: Two out of the three experimental schedules produced tans comparable with those reported by Caswell. In these two schedules, cumulative doses were a factor of 2,3 below doses from current schedules. Conclusion: The UV burden to indoor tanners can be substantially reduced without compromising the cosmetic effect. These results need to be confirmed in a larger study. [source] Latest news and product developmentsPRESCRIBER, Issue 5 2007Article first published online: 16 MAY 200 OFT wants PPRS reform The Office of Fair Trading (www.oft.gov.uk) says reform of the Pharmaceutical Price Regulatory Scheme (PPRS) would allow the NHS to re- invest £500 million in drugs it needs. Its investigation of the 50- year-old PPRS concludes that the scheme does not reflect the therapeutic value of drugs and, while providing a financial safety net for the industry, it mitigates against innovation. The OFT believes drugs should be priced according to their therapeutic value based on their cost effectiveness. Analyses would be fast- tracked for new drugs or, if there are insufficient data, a risk-sharing scheme should be adopted. The ABPI insists that its medicines offer the NHS value for money and believes the OFT's proposal for drug- by-drug pricing would delay access to new medicines. Switching saves money and is problem free Switching to cheaper alternatives within a drug class does not affect the quality of care and offers substantial savings, say UK researchers (Int J Clin Pract 2007;61:15-23). They switched selected patients from atorvastatin (Lipitor) to simvastatin and from losartan (Cozaar) to candesartan (Amias). Exclusion criteria included previous unsuccessful use, poor control of lipids or blood pressure, contraindications and potential drug interactions. In 70 patients switched to simvastatin, there was no change in mean total cholesterol after four months; one patient reverted to atorvastatin due to adverse effects. Of 115 switched to candesartan, seven reverted to losartan; in the remainder, blood pressure was slightly reduced after four months. The switch was not associated with adverse effects. Savings for the year 2005/06 were estimated at £12 716 for statins and £13 374 for antihypertensive drugs. Scotland gets donepezil for mild to moderate AD The Scottish Medicines Consortium (www.scottish medicines.org.uk) has approved the use of orodispersible donepezil (Aricept Evess) for the treatment of mild to moderate Alzheimer's disease in NHS Scotland. The decision conflicts with NICE advice that the drug is not appropriate for patients with mild disease. The SMC has not approved rimonabant (Acomplia) as adjunctive treatment for obese patients. Adherence threatens anticoagulation Patients find it difficult to adhere to anticoagulant treatment ,significantly impairing the quality of anticoagulation, US investigators have shown (Arch Intern Med 2007;167:229-35). Using electronic containers to monitor dose adherence over 32 weeks in 136 patients, they found that 92 per cent opened the container at least once too often or too little and one-third missed 20 per cent of scheduled openings. Patients with less than 20 per cent adherence were twice as likely to be undercoagulated compared with adherent patients. Those with overadherence were overcoagulated. Hypo risk greatest with glibenclamide Glibenclamide is associated with a significantly greater risk of hypoglycaemic events than other secretagogues, a new systematic review has concluded (Diabetes Care 2007;30:389-94). The review of 21 randomised trials found that the risk of experiencing at least one hypoglycaemic event was 52 per cent greater with glibenclamide compared with other secretagogues and 83 per cent greater than with other sulphonylureas. In three comparative trials with insulin, there was no significant difference in the risk of hypoglycaemia (though this could not be excluded) but only insulin was associated with weight gain. Glibenclamide was not associated with significantly increased risks of cardiovascular events, weight gain or death. Few major hypoglycaemic events were reported in these trials. Drug groups implicated in ADR admissions Four classes of drugs account for half of hospital admissions for adverse reactions, according to a new systematic review (Br J Clin Pharmacol 2007;63:136-47). Antiplatelet agents (16 per cent of admissions), diuretics (16 per cent), NSAIDs (11 per cent) and anticoagulants (8 per cent) were implicated in drug- related admissions according to a review of nine studies. Analysis of five studies also showed that adherence problems were associated with one-third of drug-related admissions. The authors suggest that focussing resources in these areas could substantially reduce admissions. Value of pharmacist MUR questioned Pharmacist medicines use review (MUR) for older patients does not reduce hospital readmission and is not cost effective by current standards, according to a study from Norfolk (Pharmacoeconomics 2007;25:171-80). A total of 872 patients aged over 80 who had been admitted as an emergency and discharged taking two or more drugs were randomised to MUR by a pharmacist or usual care. The pharmacist visited twice, providing education, removing out-of-date drugs and checking for adverse effects, interactions and the need for compliance aids. After six months, the admissions rate was not reduced among patients who received MUR and quality of life was not significantly improved. The estimated cost per QALY gained was £54 454 , above the conventional threshold for cost effectiveness of £30 000. MHRA review of LABAs The MHRA has clarified which aspects of long-acting beta-agonists (LABAs) are being addressed in its current review. This full review of salmeterol (Serevent) and formoterol, following advice issued in December last year, will consider recent research, whether the two agents differ significantly, dose-response relationships, the effect of concurrent treatment with inhaled steroid and how they are used in practice. Manufacturers have been asked to provide data by the end of March. Interventions for weight gain in schizophrenia There is not enough evidence to support the use of drugs to reduce weight gain associated with schizophrenia, a new Cochrane review has found (Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD005148. DOI: 10.1002/14651858. CD005148.pub2). Noting a lack of adequate trials, the review found that cognitive/behavioural interventions effectively prevented weight gain by a mean of 3.4kg and reduced established weight gain by a mean of 1.7kg. Drugs prevented weight gain by about 1.2kg. Switching anti-TNFs An analysis of a UK rheumatoid arthritis (RA) registry has shown that patients who stop treatment with their first anti-TNF agent should be switched to a second (Arthr Rheum 2007;56:13-20). Every UK patient with RA who receives an anti-TNF agent is included in the British Society for Rheumatology Biologics Register. Analysis of this database identified 6739 patients who started treatment, of whom 841 stopped within 15 months due to lack of efficacy and 1023 due to toxicity. Of these, 503 and 353 respectively were switched to another anti- TNF agent. Overall, 73 per cent of patients remained on their second drug by the end of follow-up, but patients were two to three times more likely to stop their second treatment for the same reason they discontinued their first. Copyright © 2007 Wiley Interface Ltd [source] The Effect of Competition on Recovery StrategiesPRODUCTION AND OPERATIONS MANAGEMENT, Issue 3 2006Mark E. Ferguson Manufacturers often face a choice of whether to recover the value in their end-of-life products through remanufacturing. In many cases, firms choose not to remanufacture, as they are (rightly) concerned that the remanufactured product will cannibalize sales of the higher-margin new product. However, such a strategy may backfire for manufacturers operating in industries where their end-of-life products (cell phones, tires, computers, automotive parts, etc.) are attractive to third-party remanufacturers, who may seriously cannibalize sales of the original manufacturer. In this paper, we develop models to support a manufacturer's recovery strategy in the face of a competitive threat on the remanufactured product market. We first analyze the competition between new and remanufactured products produced by a monopolist manufacturer and identify conditions under which the firm would choose not to remanufacture its products. We then characterize the potential profit loss due to external remanufacturing competition and analyze two entry-deterrent strategies: remanufacturing and preemptive collection. We find that a firm may choose to remanufacture or preemptively collect its used products to deter entry, even when the firm would not have chosen to do so under a pure monopoly environment. Finally, we discuss conditions under which each strategy is more beneficial. [source] Open innovation in the automotive industryR & D MANAGEMENT, Issue 3 2010Serhan Ili Automotive Original Equipment Manufacturers (OEM) have historically invested in their own research and development (R&D) to boost their innovativeness. Because of an increasing innovation and cost pressure, the automotive industry needs to look outside their own boundaries to escape from this productivity dilemma. While there is a tendency to look outside for external sources to increase the innovativeness, there are hardly any external paths to market outside the current business yet. Our study shows that Open Innovation proves to be more adequate in the attempt to achieve a better R&D productivity for companies in the automotive industry than a closed innovation model. [source] Estimation of the Investment Thresholds of Large Japanese ManufacturersTHE JAPANESE ECONOMIC REVIEW, Issue 4 2000Yuzo Honda We approximate the investment threshold by the point at which a logistic curve has the largest curvature of convexity. Our threshold estimates are 1.82 and 1.51 in Tobin's marginal Q for machinery manufacturers and chemical/metal manufacturers, respectively. These numbers lie in between the two estimates calculated by Barnett and Sakellaris for US manufacturers. Our estimates exceed one in all industries, which also agrees with Dixit and Pindyck's analytic result. The threshold for the electrical machinery industry is higher than the others. An increase in uncertainty raises the investment threshold, while an appreciation in asset value lowers it. JEL Classification Numbers: C23, E22. [source] User toolkits for innovationTHE JOURNAL OF PRODUCT INNOVATION MANAGEMENT, Issue 4 2001Eric von Hippel Manufacturers must accurately understand user needs in order to develop successful products-but the task is becoming steadily more difficult as user needs change more rapidly, and as firms increasingly seek to serve "markets of one." User toolkits for innovation allow manufacturers to actually abandon their attempts to understand user needs in detail in favor of transferring need-related aspects of product and service development to users along with an appropriate toolkit. User toolkits for innovation are specific to given product or service type and to a specified production system. Within those general constraints, they give users real freedom to innovate, allowing them to develop their custom product via iterative trial-and-error. That is, users can create a preliminary design, simulate or prototype it, evaluate its functioning in their own use environment, and then iteratively improve it until satisfied. As the concept is evolving, toolkits guide the user to insure that the completed design can be produced on the intended production system without change. Pioneering applications in areas ranging from the development of custom integrated circuits to the development of custom foods show that user toolkits for innovation can be much more effective than traditional, manufacturer-based development methods. [source] Hybrid Assembly of Metal Head and Femoral Stem From Different Manufacturers During Isolated Acetabular RevisionARTIFICIAL ORGANS, Issue 8 2010Cheng-Fong Chen Abstract During revision of a failed acetabular component with well-fixed antiquated femoral stem, the same variant of metal head is usually not available in the inventory production. We gathered the stems retrieved from revision surgeries and tried to reassemble with the commercially available femoral heads. This study reports the results of suitable hybrid assembly of metal heads with the most common antiquated femoral stems from different manufacturers. Three hybrid combinations were determined and pull-off strengths of these hybrid combinations were performed through in vitro studies to evaluate the quality of the taper locks. [source] Technological Capability and FDI in Asia: Firm-level Relationships among Japanese Manufacturers*ASIAN ECONOMIC JOURNAL, Issue 3 2005Eiichi Tomiura F23; L22 The present paper reexamines the relationship between technological capabilities and FDI decisions at the firm level. The data cover 118 300 Japanese firms in all manufacturing industries. The R&D of Japanese firms has a noticeably weaker relationship with FDI in Asia than with FDI in industrial countries. This finding is confirmed to be robust even when alternative estimation techniques are used and when R&D expenditure data are replaced by patent data. The estimation results also reveal non-negligible fixed entry costs for FDI, a finding consistent with the observation that only approximately 2 percent of the firms invest abroad. [source] HPLC of basic drugs using non-aqueous ionic eluents: evaluation of a 3,,m strong cation-exchange materialBIOMEDICAL CHROMATOGRAPHY, Issue 3 2010Phillip E. Morgan Abstract HPLC columns packed with 3,,m particle size HPLC Technology Techsphere SCX (propylsulfonic acid-modified) silica offer considerable advantages over 5,,m SCX packings in the analysis of basic drugs using 100% methanol eluents containing an ionic modifier such as ammonium perchlorate. The basic drugs studied included clozapine and norclozapine, olanzapine, quinine and quinidine, and amitriptyline, nortriptyline, imipramine and desipramine. The 3,,m column was not only more efficient for a given column length compared with 5,,m materials, but also elution times were less, a phenomenon observed in reversed-phase systems. The high efficiencies and excellent peak shapes obtained with the 3,,m SCX-modified packing together with the relatively low back-pressures attained show that such materials deserve serious consideration by laboratories involved in the analysis of basic drugs. Manufacturers should offer such packings as a matter of routine. Alternative ionic modifiers such as ammonium acetate are available for use with mass spectrometric detection if required. Copyright © 2009 John Wiley & Sons, Ltd. [source] Manufacturers and suppliers informationBIOMEDICAL CHROMATOGRAPHY, Issue 10 2005Article first published online: 28 NOV 200 First page of article [source] | ||||||||||||||||||||||||||||||||||||||||||||||