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Regulators, patients and industry all agree there needs to be improved practices for detecting safety problems post-market. Many marketed products are now being called into question whether they should be on the market. Brand owners are responding to this criticism by improving their post-market surveillance with Phase IV tools and Post-Market Risk Assessment. Join industry colleagues at this networking forum where we will evaluate how companies are: s Raising the standard of quality and safety of marketed drugs demanded by regulators and patients s Optimising product potential and gaining competitive advantage through effective post-market surveillance s Developing patient, product and pregnancy registries to enhance Risk Management programmes s Continually assessing and demonstrating safety around and after launch through effective post-marketing studies s Employing improved post-marketing studies, including investigator-initiated, sponsor-led and observational studies s Integrating Phase IV tools and trials with Post-Market Risk Assessment for safer marketed medicines s Evaluating spontaneous adverse event reports effectively s Utilising Pharmacoepidemiology as an invaluable Risk Management tool s Integrating science and marketing interests and balancing clinical, commercial and public safety interests, for example, nifedipine.
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ECOTOXICITY Aquatic Activated Sludge Respiration Algal This material contains an active pharmaceutical ingredient that is not toxic to activated sludge microorganisms. 536 mg l, 3 Hours, Activated sludge, Nominal IC50: This material contains an active pharmaceutical ingredient that is harmful to algae. IC50: 26 mg l, 72 Hours, Scenedesmus subspicatus, green algae, Measured NOEL: 8.9 mg l, 72 Hours, Scenedesmus subspicatus, green algae, Measured This material contains an active pharmaceutical ingredient that is not toxic to daphnids. This material contains an active pharmaceutical ingredient that is harmful to daphnids in chronic toxicity studies. EC50: 206 mg l, 48 Hours, Daphnia pulex, Measured NOEL: 142 mg l, 48 Hours, Daphnia pulex, Measured Chronic LOEC: Chronic NOEC: Fish 71 mg l, 8 Days, Ceriodaphnia dubia, Static renewal test 23 mg l, 8 Days and pravachol, for example, side affects.
The following table describes each of the elements and attributes and how they are used: Element or Attribute QueryResponse Data Type Complex Type Description The root element containing all response elements. Occurs just once. Element that contains all credit details for the specified date. Occurs just once. If there are no credit details then this container will not include any CreditDetail elements. date YYYY-MM-DD The date when the credit detail where calculated. Specifies the right type of the FTR Specifies a single detail. Occurs 0 to many times. Name of the market. Annual auction round 1, 2, 3, ; . Not used for monthly markets. Specifies the FTR path. Occurs just once. Specifies the FTR path source node. Specifies the FTR path sink node.
There can be no doubt that Pfizer, along with other research-based pharmaceutical companies, is facing the headwinds of an operating environment quite unlike any we have ever seen. We face severe pricing pressures, a contentious political atmosphere, and a maze of new regulatory demands. We are in a period of "discontinuous change"--where many of the assumptions of the last half-century no longer hold true. These industry-wide challenges are compounded for Pfizer by the fact that we will lose patent protection on several of our best-selling medicines between this year and the end of 2007. In spite of the operating environment, Pfizer had a solid year in 2004. We reached new highs in revenues, earnings, and dividends. We also passed important milestones in our multi-year plans to manage through the years ahead, and seize the opportunities that always emerge from turbulent change. Pfizer is well equipped to move forward. We have greatly increased our size and reach. Our 2004 revenues of $52.5 billion are double those of just five years ago. We have also accelerated our pharmaceutical R&D programs, moving toward our goal of filing an industry-record 20 new medicines in the U.S. between 2001 and 2006. We have revitalized our Animal Health and Consumer Healthcare businesses, and progressed toward a Human Health business that is more closely and prednisone.
The committee's composition and number of participants were established with the assistance of the Cancer Department of the American College of Surgeons. The committee meets 12 times per year and reports to the Executive Committees of Forsyth Medical Center, Medical Park Hospital and Thomasville Medical Center. The committee is responsible for initiating and assessing all cancerrelated activities at the hospitals. The American College of Surgeons Cancer Department assisted in establishing the number and composition of the joint committee.
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6. Market Access Obstacles. 28 6.1 Tariffs. 29 6.2 Project Approvals . 29 6.3 Limitation of New Projects due to Austerity Measures . 30 6.4 Intellectual Property Rights . 30 6.5 Chinese Legislation on New and Toxic Chemical Substances . 30 6.6 Export Controls on Rare Earth Materials . 31 6.7 Survey Results . 31 6.8 Quantification of Market Access Obstacles . 32 7. Scenarios Regarding the Future Development of the Chinese Chemicals Industry. 33 7.1 Scenario 1 Pessimistic Scenario. 33 7.2 Scenario 2 Optimistic Scenario. 35 7.3 Other Variables: . 37 8. Conclusion: Changes, Challenges and Choices . 39 9. Policy Recommendations . 39 9.1 Policy Recommendations in the Frame of China's Entry to the WTO . 39 9.2 General Policy Recommendations . 42 9.3 Recommendations for Competitiveness. 43 Annex 1: The Chinese Petrochemical Industry. 46 Annex 2: SWOT Summaries per sub-sector ; . 50 Annex 3: Factors Influencing Competitiveness in the Chinese Market . 53 Annex 4: Tariffs on Selected Chemicals . 54 Annex 5: CEFIC Scenarios Regarding the Future Development of the European Chemical Industry. 55 Annex 6: China Strategies of Some Selected Major European Chemical Companies . 57 Annex 7: Relevant Government Institutions for China's Chemicals Sector. 58 Annex 8: Table of Key Laws and Regulations pertaining to chemicals sector. 59 Annex 9: Industry Survey Results . 60 and prinivil.
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Care Choices HMO will be fully compliant with the April 21, 2005 deadline for the Health Insurance Portability and Assurance HIPAA ; Security Rule. What is the Security Rule? The Security Rule establishes minimum standards for protecting the security of electronic protected health information PHI ; . The Security Rule sets the standard for how to protect electronic PHI from unauthorized access, alteration, deletion and transmission. PHI includes information such as a member's name, address, phone number, Social Security number, other demographic information and information regarding health condition or diagnosis. What has Care Choices HMO done to become compliant? Care Choices HMO has set up policy and procedures to make certain only approved users have access to our system. Each user is given a unique username and password and we have reviewed the user roles on our system to make certain users have only what is minimally necessary and appropriate according to their job description. Monthly audits are preformed to make certain no breaches have occurred. If you have any questions regarding Care Choices HMO compliance with HIPAA, please contact your Account Executive or Business Support at 800 ; 261-3452.
Percent increase in the probability that otitis would resolve when antibiotic therapy was given versus no treatment Stool et al., 1994 ; . During the initial management period up to 12 weeks ; , observation of the otherwise healthy child with a unilateral effusion is the treatment of choice Berman et al., 1994 ; . Myringotomy, with or without.
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SnET2 SnET2 0.5 mg kg 0.75 mg kg n 372 n 372 n 183 Incidence and duration of photosensitivity adverse events Per patient 2.7% 9.6% 18.8% Per administration 1.1% 4.8% 11.2% * Measurement Placebo Median time to onset Median duration Severe photosensitivity Moderate photosensitivity Mild photosensitivity Symptoms or other surgical medical procedures drug-related Per patient Per administration 2 days 5 days None Mostly Some 16.9% 5 days 4 days None Some Some 14.0% 5 days 7.5 days Few Some Mostly ~15.4 and potassium.
Patients receiving extended-release nifedipine procardia xl ; were converted to either amlodipine norvasc ; or felodipine plendil ; through the institution's conversion program.
BOURNE, S.3, NORTH, N., BAKER, A.3 `New Zealand: the office of the Health and Disability Commissioner'. In: Thomas, D. ed. ; , Medicine called to account: health complaint mechanisms in Australasia. Sydney, Australian Studies in Health Services Administration No. 93, School of Public Health and Community Medicine, University of New South Wales, p.85-96, 2002. FORBES, I.3, NORTH, N.H., HOGARTH, J.3, HOVENGA, E.3 `Case studies in health service management'. In: Harris, M.G., et. al. eds. ; , Managing health services: concepts and practices. NSW Australia, MacLennan and Petty, p.427-428, 2002. NORTH, N.H. `Using research and evaluation in managing health services'. In: Harris, M.G., et. al. eds. ; , Managing health services: concepts and practices. NSW Australia, Petty, p.403-426, 2002. PAPPS, E., KILPATRICK, J. `Nursing education in New Zealand: past, present and future'. In: Papps, E. ed. ; , Nursing in New Zealand: Critical issues, different perspectives. Pearson Education, Auckland, pp 1-13, 2002.
1. Bandyopadhya S, Bayer A, O'Mahon M. Age and gender bias in statin trials. QJM 2001; 94: 12732. Doyal L. Sex, gender and health: the need for a new approach. BMJ 2001; 323: 10613. Fishman J, Wick J, Koenig B. The use of `sex' and `gender' to define and characterize meaningful differences between men and women. In Agenda for Research on Women's Health for the 21st Century. Bethesda, MD: National Institutes of Health; 1999. 4. Mastroianni A, Faden R, Federman D, editors. Women and health: ethical and legal issues of including women in clinical studies. Vols 1 and 2. Washington, DC: National Academic Press; 1994. 5. Love CB, Thomson EJ, Royal CD. Ethical issues in research involving human participants. Office of Research on Women's Health Recruitment and Retention of Women in Clinical Studies. NIH Publication 953756. Bethesda, MD: US Department of Health and Human Services; 1999.
The effort to sustain our gains in public health and environmental health protection will be most effective if regulatory and public health agencies work together. Regulatory and public health agencies have important and complementary roles to play in setting policies for environmental health protection and risk management. Yet, in general, these two communities do not interact sufficiently, and the connections between environmental exposures and public health are not well established. The likely synergy between environmental and public health agencies is a reservoir of untapped potential for environmental risk management. Many environmental pollution problems can be identified by their public health contexts. For example, construction of an asphalt batch plant was proposed in Boston. Public health officials found that the residents of the urban community in which it was to be constructed had a relatively high incidence of asthma and cardiovascular disease. Those findings signaled a potential environmental health problem that could have been exacerbated by emissions from the asphalt plant. On that basis, construction of the plant was opposed by citizens and by the public health agency, and a decision was made to try to locate the plant elsewhere. Environmental, public health, and social agencies can work together with community activists to define problems and to develop and implement strategies to manage environmental risks in the full context of poverty, poor schools, and inadequate housing. As our society works to reduce risks in an era of diminishing resources, it is vital that environmental and public health agencies collaborate in deploying the tools of public health--epidemiology, exposure assessment, surveillance, nutrition, genetics, and behavior change-- to identify and evaluate the most cost-effective ways to reduce risks and improve public health in all segments of the population. The public health community should accept an influential role in setting national, state, and local priorities and in developing strategies to understand, manage, and prevent environmental risk.
The systemic plasma clearance of felodipine in young healthy subjects is about 0.8 L min, and the apparent volume of distribution is about 10 L kg. Following an oral or intravenous dose of 14C-labeled felodipine in man, about 70% of the dose of radioactivity was recovered in urine and 10% in the feces. A negligible amount of intact felodipine is recovered in the urine and feces 0.5% ; . Six metabolites, which account for 23% of the oral dose, have been identified; none has significant vasodilating activity. Following administration of PLENDIL to hypertensive patients, mean peak plasma concentrations at steady state are about 20% higher than after a single dose. Blood pressure response is correlated with plasma concentrations of felodipine. The bioavailability of PLENDIL is influenced by the presence of food. When administered either with a high fat or carbohydrate diet, Cmax is increased by approximately 60%; AUC is unchanged. When PLENDIL was administered after a light meal orange juice, toast, and cereal ; , however, there is no effect on felodipine's pharmacokinetics. The bioavailability of felodipine was increased approximately twofold when taken with grapefruit juice. Orange juice does not appear to modify the kinetics of PLENDIL. A similar finding has been seen with other dihydropyridine calcium antagonists, but to a lesser extent than that seen with felodipine. Geriatric Use-- Plasma concentrations of felodipine, after a single dose and at steady state, increase with age. Mean clearance of felodipine in elderly hypertensives mean age 74 ; was only 45% of that of young volunteers mean age 26 ; . At steady state mean AUC for young patients was 39% of that for the elderly. Data for intermediate age ranges suggest that the AUCs fall between the extremes of the young and the elderly. Hepatic Dysfunction-- In patients with hepatic disease, the clearance of felodipine was reduced to about 60% of that seen in normal young volunteers. Renal impairment does not alter the plasma concentration profile of felodipine; although higher concentrations of the metabolites are present in the plasma due to decreased urinary excretion, these are inactive. Animal studies have demonstrated that felodipine crosses the blood-brain barrier and the placenta. Cardiovascular Effects Following administration of PLENDIL, a reduction in blood pressure generally occurs within 2 to 5 hours. During chronic administration, substantial blood pressure control lasts for 24 hours, with trough reductions in diastolic blood pressure approximately 40-50% of peak reductions. The antihypertensive effect is dose dependent and correlates with the plasma concentration of felodipine. A reflex increase in heart rate frequently occurs during the first week of therapy; this increase attenuates over time. Heart rate increases of 5-10 beats per minute may be seen during chronic dosing. The increase is inhibited by beta-blocking agents. The P-R interval of the ECG is not affected by felodipine when administered alone or in combination with a betablocking agent. Felodipine alone or in combination with a beta-blocking agent has been shown, in clinical and electrophysiologic studies, to have no significant effect on cardiac conduction P-R, P-Q, and H-V intervals ; . In clinical trials in hypertensive patients without clinical evidence of left ventricular dysfunction, no symptoms suggestive of a negative inotropic effect were noted; however, none would be expected in this population see PRECAUTIONS ; . Renal Endocrine Effects Renal vascular resistance is decreased by felodipine while glomerular filtration rate remains unchanged. Mild diuresis, natriuresis, and kaliuresis have been observed during the first week of therapy. No significant effects on serum electrolytes were observed during short- and long-term therapy. In clinical trials in patients with hypertension, increases in plasma noradrenaline levels have been observed. Clinical Studies Felodipine produces dose-related decreases in systolic and diastolic blood pressure as demonstrated in six placebocontrolled, dose response studies using either immediaterelease or extended-release dosage forms. These studies enrolled over 800 patients on active treatment, at total daily doses ranging from 2.5 to 20 mg. In those studies felodipine was administered either as monotherapy or was added to beta blockers. The results of the 2 studies with PLENDIL given once daily as monotherapy are shown in the table below: MEAN REDUCTIONS IN BLOOD PRESSURE mmHg.
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PROVIDER RESPONSIBILITIES P GLTC contracted providers will provide high quality services to eligible members. Contracted providers are expected to abide by all terms specified in their contract with P GLTC. The contract includes general and special provisions, reimbursement rates, claim submission requirements and work statements detailing service delivery. When contracting providers determine that the terms of their contract contradict the delivery of appropriate care, the provider should discuss this issue with their assigned contract representative. Non-contracted providers are expected to be registered as AHCCCS providers to be eligible for payment of services provided to P GLTC members. Non-contracted providers are only used in instances when they are no contracted P GLTC providers available. Non-contracted providers are reimbursed at the AHCCCS fee-for-service rates, cost-to-charge ratios or hospital tiered per diem as established by AHCCCS for the provider service type and facility classification. Noncontracted providers are expected to comply with all AHCCCS rules and regulations pertaining to their category of service. Non-contracted service providers should contact the P GLTC Provider Services Section for questions related to service delivery and conflicts. Before providing services to members, providers will verify each member's stated identification. Services provided to persons misrepresenting their identities will not be reimbursed. Providers will work with Case Managers to resolve member issues prior to requesting a reassignment of the member. Providers shall utilize Case Managers to coordinate medical and other appropriate care and participate in care conferences as requested. Primary Care Physicians PCP ; will serve as a gatekeeper and coordinator in referring the member for specialty medical, behavioral health and dental services. Coordination of medical care and acting as a gatekeeper includes but is not limited to the following responsibilities: a. b. c. Initiate and coordinate all medically necessary and appropriate referrals to contracted providers. When appropriate and necessary, refer members to an out of network provider in order to obtain services. Oversee drug regimens to prevent negative interactive effects. Follow-up for all emergency services. Coordinate inpatient care. Coordinate the provision of medically necessary dentures. Maintain continuity of care for each assigned member.
Performs smear and culture tests on patient specimens to identify Mycobacterium tuberculosis and drug susceptibility tests to identify drug resistance. 2 ; Contact Investigation The Georgia TB program institutes policies and procedures to ensure that a thorough medical evaluation of contacts to TB cases or contact investigation is promptly initiated and completed. During a contact investigation, two separate interviews of TB cases are performed to identify the contacts of each TB case. The closest contacts of a person with infectious TB are evaluated first with a Mantoux tuberculin skin test. The skin test is repeated after 3 months if the first test is negative. A chest radiograph is done for persons with a positive skin test. If a high rate of infection is found among a group of close contacts, the next closest circle of contacts is investigated. Contacts evaluated as having latent TB infection LTBI, i.e., infection with TB bacilli but persons are not sick and not infectious ; are treated with preventive medications if indicated. Preventive medication treatment to prevent LTBI from progressing to active TB disease ; usually takes nine months to complete. Since the implementation of a zero tolerance for zero contacts policy in 1999, contact identification has increased from 45% 301 of 670 cases ; in 1999 to 92% 494 535 ; in 2002. The percent of contacts completely evaluated for TB infection or TB disease was 63% in 2002. In 2002, the year with most complete data on contacts to TB cases, 904 19% ; contacts evaluated had LTBI, 70% of who were started on LTBI treatment. Of 513 infected contacts with available treatment completion data in 2002, only 56% completed LTBI treatment. In 2002, 122 76% ; of contacts less than 15 years of age with LTBI were started on LTBI treatment and 84% completed LTBI treatment. 3 ; TB Surveillance Reporting The state TB program is responsible for maintaining a registry of TB cases, for collecting and storing complete and reliable data, and protecting the confidentiality of the data. New cases of active TB and latent TB infection in children less than 5 years of age LTBI 5 ; are legally mandated notifiable diseases in Georgia. Surveillance data are routinely analyzed to monitor trends among.
Interestingly, the rate of muscle proteolysis and levels of ubiquitin-proteasome pathway mRNAs were regulated in a coordinated fashion. In studies of ADX rats with diabetes or diabetic rats given insulin, a change in protein degradation was accompanied by a parallel change in mRNA levels. Thus we could not determine whether there is interdependence between the two types of responses, as occurs in septic rats, despite attempts to shorten the duration of time for exposure to insulin 29 ; . The E214k ubiquitin-carrier enzyme is encoded by two species of mRNA, 1.8- and 1.2-kb mRNA. These mRNAs differ in the length of their 3 -untranslated regions 3 -UTR ; , but their translation products are identical 30 ; . It not known whether these mRNAs are translated with equal efficiency. Notably, Wing and Bedard 31 ; found that insulin-like growth factor I or insulin will increase the rate of the 1.2-kb mRNA degradation but not of the 1.8-kb species and concluded that the additional 3 -UTR in the 1.8-kb E214k mRNA confers stability 31 ; . This pattern of regulation of the E214k mRNAs is interesting, because we found that insulinopenia increases the 1.2- but not the 1.8-kb form. Our finding is consistent with activation of at least one ubiquitin-carrier protein, E214k, and an increase in ubiquitin-conjugating activity in muscle unpublished observations ; . Taken together, these studies make it tempting to speculate that one mechanism leading to suppression of protein degradation by insulin could involve reduced activity of one or more ubiquitincarrier enzymes. We do not know why the 1.8-kb E214k mRNA was increased in muscles of diabetic rats given bicarbonate inasmuch as this response was not found in any other group of diabetic rats. Possibly, the increase in this mRNA was in response to bicarbonate directly or their mild alkalosis Table 1 ; rather than hyperglycemia or insulinopenia. It is notable that the proteolytic response to acute diabetes and other catabolic conditions e.g., acidosis and sepsis ; not only involves glucocorticoids 17, 23, 28 ; but often is also associated with reduced or impaired responses to insulin [e.g., uremia, sepsis, and acidosis 7, 14, 17 ; ], whereas starvation is associated with reduced insulin levels. Thus impaired insulin action and or relative insulin deficiency could be a common factor activating protein degradation in these conditions, since the present results show that a low insulin level is a signal activating the ubiquitin-proteasome system. In summary, muscle wasting in acute diabetes results from activation of the ubiquitin-proteasome proteolytic pathway by a mechanism that requires glucocorticoids. We have excluded a high blood glucose concentration or acidification as independent mediators activating muscle proteolysis in diabetes. It is tempting to speculate that the insulin signal transduction pathway acts to suppress the ubiquitin-proteasome system. In this case, insulin resistance in other conditions e.g., sepsis, burn injury, and metabolic acidosis ; would contribute to muscle atrophy, especially if glucocorticoid production were high.
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Table 1. Susceptibility rates of isolated microorganisms Organism A. baumannii P. aeruginosa K. pneumoniae Enterobacter spp. E. coli Serratia spp. Stenotrophomonas maltophilia P. mirabilis Citrobacter spp. Pseudomonas spp. Total n 90 81 % 24.5 22.0 19.9 AMK 16 ; 55.5 58.0 52.0 0 100 GM 4 ; 21.1 72.8 53.4 0 IMP 4 ; 66.6 83.9 89.0 0 Antibiotic NCCLS breakpoint MIC value mg ml ; AUG CFT CAZ CAX CFD CPM PTZ 8 ; 8 ; 8 ; 5.5 27.1 34.2 0 0 60.0 66.6 0 22.5 2.2 19.7 0 34.0 61.1 39.5 0 35.9 4.4 13.6 0 32.9 71.1 59.2 CP 1 ; LV CAZ CLV 16 ; 10.0 13.5 57.5 0 0 0 21.1.
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