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If any of our products receive regulatory approval, the approval will be limited to those disease states and conditions for which the product is safe and effective, as demonstrated through clinical trials. In addition, results of pre-clinical studies and clinical trials with respect to our products could subject us to adverse product labeling requirements which could harm the sale of such products. Even if regulatory approval is obtained, later discovery of previously unknown problems may result in restrictions of the product, including withdrawal of the product from the market. Further, governmental approval may subject us to ongoing requirements for post-marketing studies. Even if we obtain governmental approval, a marketed product, its respective manufacturer and its manufacturing facilities are subject to unannounced inspections by the FDA and must comply with the FDA's cGMP and other regulations. These regulations govern all areas of production, record keeping, personnel and quality control. If a manufacturer fails to comply with any of the manufacturing regulations, it may be subject to, among other things, product seizures, recalls, fines, injunctions, suspensions or revocations of marketing licenses, operating restrictions and criminal prosecution. Other countries also impose similar manufacturing requirements. Our promotional materials and sales activities are governed by FDA regulation. The FDA may require us to withdraw promotional material, to issue corrected material, or to cease promotion resulting in loss of credibility with our customers, reduced sales revenue or increased costs. As a result of our 2007 and 2006 restructuring initiatives and the related reductions in our workforce, we have reallocated certain employment responsibilities and will be required to outsource certain corporate functions, which will render us more dependent on third-parties to perform these corporate functions. On March 14, 2007 we announced a restructuring initiative which included reductions in our world-wide workforce as well as our intention to transition the company to an outsourcing business strategy. The reductions will result in the reallocation of certain employment responsibilities, which could adversely impact operational efficiencies, employee performance and retention. Also, as a result of these reductions, we will be required to outsource certain corporate functions which will make us more dependent on third-parties for the performance of these functions in connection with our business and product candidates. To the extent that we are unable to effectively reallocate employee responsibilities, retain key employees, establish and maintain agreements with competent third-party contractors on terms that are acceptable to us, or effectively manage the work performed by any retained third-party contractors, our ability to advance our business or product candidates may be significantly impaired and our stock price may be adversely affected. If we fail to attract and retain key employees, the development and commercialization of our products may be adversely affected. We depend heavily on the principal members of our clinical development and management staff. To the extent that we lose key personnel, our ability to develop products and become profitable may suffer. The risk of being unable to retain key personnel may be increased by the fact that we have not executed long-term employment contracts with our employees. Our future success will also depend in large part on our ability to attract and retain other highly qualified personnel. We face competition for personnel from other companies, academic institutions, government entities and other organizations. After the 2007 restructuring, we will base our operations in Parsippany, New Jersey. Our future success will depend in part on how well we are able to transition activities in our Toronto and Salt Lake City locations to our Parsippany location. We are dependent upon key members of our management team who are employed at will and will be difficult to replace should they leave the company. If we are unable to retain members of our management team or if we are unable to attract and retain other highly qualified executives and employees in our industry, we may not be able to successfully implement our business strategy. We are highly dependent on key members of our management team, including Dr. Anthony Coles, our Chief Executive Officer and President, to manage our business. In addition to Dr. Coles, we have hired other key members of our management team over the past two years, each of whom is highly qualified, important to our business and would be difficult to replace. 32.
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At the Second Annual General Meeting of the SNN, held on October 26th, three Directors were elected from a slate of five candidates to fill industry vacancies on the Board. These Directors, listed below, will serve a two 2 ; year term October, 1999 to October, 2001 ; or until their respective successors are elected or appointed: x Mr. Mark Pickard, InfraReady Products x Mr. Roy Sangster, Sangster Health Centres x Dr. Alison Stephen, CanTox Health Sciences International In addition to those listed above, the Board is comprised of: x Mr. Jerome Konecsni, Bioriginal Food & Science, CHAIR x Mr. John Christensen, Fytokem Products, VICE-CHAIR x Mr. Don Hrytzak, Taiga BioActives, SECRETARY-TREASURER x Ms. Maryellen Carlson, Saskatchewan Agriculture and Food, MEMBER, EXECUTIVE COMMITTEE x Dr. Dennis Gorecki, College of Pharmacy & Nutrition, University of Saskatchewan x Mr. John Hyshka, Saskatoon Regional Economic Development Authority x Ms. Melody Machmer, Mid Northern Growers x Dr. Gopalan Selvaraj, Plant Biotechnology Institute, because imdur 90 mg.
Source: Wyoming Medicaid Statistical Information System, 2000 and 2001. * Data on recipients and expenditures by maintenance assistance status and basis of eligibility are unavailable.
SPRINGFIELD Legislators serving on the Joint Committee on Administrative Rules JCAR ; today voted to make permanent Governor Rod R Blagojevich's emergency rule that ensures pharmacies in Illinois fill women's prescriptions for contraceptives without delay or hassle. The rule requires licensed pharmacies that dispense FDA-approved contraceptives to fill all birth control prescriptions in the same timely manner they would other prescriptions. "Women can feel confident from here on out, that when they have a signed prescription from their doctor for birth control and go to a pharmacy that sells birth control they'll get their medication quickly without questions or lectures. When we began this battle, we said that filling prescriptions for birth control is about protecting a woman's right to have access to medicine her doctor says she needs. Nothing more. Nothing less, " said Gov. Blagojevich. Gov. Blagojevich submitted an emergency rule on April 1, 2005 clarifying the responsibilities of licensed retail pharmacies to fill prescriptions for all FDA approved contraceptives if the drug store dispenses birth control medications. That rule remained in effect in an emergency capacity until today, when JCAR voted to allow the Governor's rule to become permanent. "Illinois women can breathe easier, knowing that they have a right to go into a drug store anywhere in the state and get their birth control prescriptions filled, " said Rachel Laser from the National Women's Law Center. "I'm hopeful that women across the country and their supporters in state legislatures and the U.S. Congress will follow the example set by Gov. Blagojevich to protect the health and dignity of women." The rule clearly defines the responsibilities of licensed retail pharmacies in Illinois to fill all FDA approved birth control prescriptions if the drugs are in stock and a legal prescription has been presented. If the drugs requested are not in stock, the pharmacy must do one of the following: provide a medically acceptable alternative drug, or, at the request of the patient, order and sorbitrate.
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Executive Summary. v Introduction . 1 Voluntary Consensus Standards for Hospital Care . 3 Scope. 3 Priority Areas for Hospital Care Performance Measurement. 3 Criteria for Selection of Measures. 4 Box A: Criteria for Evaluation and Selection of Measures . 4 The NQF-Endorsed Measures. 4 Purpose of the Endorsed Voluntary Consensus Standards . 4 The NQF-Endorsed Purpose of the Measure Set . 5 Acknowledgments . 5 Table 1: National Voluntary Consensus Standards for Hospital Care . 6 Appendix A-- Steering Committee, Workshop Participants, and Project Staff . A-1 Appendix B -- Steering Committee and Workshop Commentary. B -1 Appendix C -- Specifications of the National Voluntary Consensus Standards for Hospital Care . C -1 Appendix D-- Acronyms and Glossary . D-1 Appendix E -- Selected References. E -1 Appendix F -- Members and Board of Directors . F -1 Appendix G-- Consensus Development Process: Summary. G-1 and imipramine, for example, imdur prescribing.
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2. Pert, C. B. & Snyder, S. H. 1974 ; Mol. Pharmacol. 10, 868879. 3. Pasternak, G. W., Snowman, A. M. & Snyder, S. H. 1975 ; Mol. Pharmacol. 11, 735-744. 4. Terenius, L. & Wahlstrcm, A. 1975 ; Life Sci. 16, 1759-1764. 5. Pasternak, G. W., Goodman, R. & Snyder, S. H. 1975 ; Life Sci. 16, 1765-1769. 6. Hughes, J. 1975 ; Brain Res. 88, 296-308. 7. Hughes, J., Smith, T., Morgan, B. & Fothergill, L. 1975 ; Life Sci. 16, 1753-1758. 8. Bentley, K. W. & Lewis, J. W. 1973 ; in Agonist and Antagonist Actions of Narcotic Analgesic Drugs, ed. Kosterlitz, H. W., Clouet, D. H. & Villarreal, J. E. University Park Press, Baltimore, Md. ; , pp. 7-16. 9. Mule, S. J. 1971 ; in Narcotic Drugs, ed. Clouet, D. H. Plenum Press, New York ; , pp. 99-121. 10. Scrafani, J. T. & Clouet, D. H. 1971 ; in Narcotic Drugs, ed. Clouet, D. H. Plenum Press, New York ; , pp. 137-158. 11. Loew, G. H. & Berkowitz, D. S. 1975 ; J. Med. Chem. 18, 656-662. 12. Takeda, M., Konda, M., Inoue, H., Saito, S., Kugita, H. & Nurimoto, S. 1973 ; in Narcotic Antagonists, eds. Braude, M., Harris, L., May, E., Smith, J. & Villarreal, J. Raven Press, New York ; , pp. 113-121. 13. Albertson, N. F. 1975 ; J. Med. Chem. 18, 619-621. 14. Beckett, A. H. & Casey, A. F. 1954 ; J. Pharm. Pharmacol. 6, 986-1001. 15. Portoghese, P. S. 1966 ; J. Pharm. Sci. 55, 865-887. 16. Perutz, M. F. & TenEyck, L. F. 1971 ; Cold Spring Harbor Symp. Quant. Biol. 36, 295-310. 17. Perutz, M. F. 1970 ; Nature 228, 726-734. 18. Snyder, S. H. 1975 ; Nature 257, 185-189. 19. Pauling, L. 1970 ; The Nature of the Chemical Bond Cornell Univ. Press, Ithaca, N.Y. ; . 20. Besendorf, H., Pellmont, B., Bachtold, P., Reber, K. & Studer, A. 1962 ; Experlentia 18, 446-467. 21. Ong, H. H., Oh-ishi, T. & May, E. L. 1974 ; J. Med. Chem. 17.
In addition, in patients' assessment of Quality of Analgesia, 60.9% of patients taking Remoxy and 38.4% of placebo patients rated the overall quality of analgesia as excellent, very good, or good Fig. 5; p 0.001 ; . A trend towards better global assessment of study medication was noted in the Remoxy group at the end of treatment p 0.097 and indapamide.
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Benign Prostate Hyperplasia In addition to traditional therapeutic techniques, Dr. Michael O'Leary has been instrumental in utilizing a new procedure called ambulatory thermotherapy. This technique, used when other medical treatments fail, involves heating the prostate gland with microwaves. The entire procedure lasts roughly 28 minutes and reduces inflammation within three days. This ambulatory procedure has been very effective for patients with modest bladder outlet symptoms who have failed pharmacologic agents. removed one week post-operatively. We perform approximately 300 nerve-sparing procedures annually. Intraoperative MR guided brachytherapy Our team of radiologists, radiation oncologists and surgeons performed the first brachytherapy utilizing an open intraoperative MRI that results in more accurate seed placement and better dosimetry to the prostate while sparing the urethra. This innovative technique has improved quality-of-life while assuring excellent dosimetry, because ikdur conversion.
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FIGURE 2. After HIV-1 infection, CD8 expression on SP thymocytes declines as MHC I expression increases in the SCID-hu Thy Liv mouse. A, CD8 expression on SP thymocytes declines over the course of X4 HIV-1 infection. Implants were collected from mock- and NL4-3-infected SCID-hu Thy Liv mice 28 days after inoculation and thymocytes were stained for CD4 and CD8. The CD8 MFI on SP8 thymocytes in the mock- and NL4-3-infected implants was 1181 and 475, respectively. B, CD8 expression on SP8 thymocytes declines over the course of R5 HIV-1 infection. Mock- and Ba-L-infected SCID-hu Thy Liv mice were analyzed as in A. The CD8 MFI on SP8 thymocytes in the mock- and Ba-L-infected implants was 1328 and 815, respectively. Histograms in A and B are representative of two to five mice per group collected 28 days after inoculation. C, MHC I expression on DP thymocytes increases and CD8 MFI on SP8 thymocytes declines over the duration of NL4-3 infection. SCID-hu Thy Liv implants were mock-infected or injected with 3000 TCID50 of NL4-3. Infected implants were harvested at the indicated times and analyzed for MHC I expression on DP cells, CD8 expression on SP8 cells, and CD4 expression on SP4 cells. CD8 MFI on SP8 thymocytes declined during the same time frame that MHC I expression on DP thymocytes increased, while CD4 MFI on SP4 thymocytes remained unchanged. Each data point F ; represents an individual implant from mice in the same cohort. Means are shown as bars. D, MHC I expression on DP thymocytes increases and CD8 MFI on SP8 thymocytes declines over the duration of Ba-L infection. SCID-hu Thy Liv implants were inoculated with 2000 TCID50 of Ba-L. Implants were harvested at the indicated times and analyzed as described in C. E, CD4 CD8low thymocytes are CD3high. Mock- and Ba-L-infected SCID-hu Thy Liv implants were harvested at 21 days after inoculation and stained for CD4, CD8, and CD3. SP8 thymocytes demonstrated a similar CD3high profile in mock-infected open histogram ; and Ba-L-infected filled histogram ; implants. In all cases analyzed in Fig. 2 and in Table I, SP8 thymocytes were defined as being CD4low whereas SP4 thymocytes were defined as being CD8low see gating strategy shown in A and ketorolac and imdur, for example, imdur 30 mg.
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Phenotype Van A, responsible for resistance to vancomycin and teicoplanin, mainly in E. faecalis and E. faecium strains. This resistance appears often as a result of earlier antibiotic therapy. The gene responsible for this type of resistance is located in transposon Tn1546 and can be transferred to other strains of enterococci as well as staphylococci. The frequency of such strains differs in Europe as well as around the world. The first vancomycin resistant strain was isolated in Poland in 1996 in a haematology unit Bronk et al., 1997; Hryniewicz et al., 1998 ; . The recommended drug for treatment of infections caused by multiresistant enterococci and VRE is a streptogramin group representative-synercid quinupristin dalfopristin ; Dzieranowska et al., 2004; Hayes et al., 2001; Hryniewicz et al., 2003; Moellering et al., 1999 ; . Synercid is also used in cases of infections caused by methicillin resistant and vancomycin resistant staphylococci strains MRSA, VRSA ; . It has been proved that even after a few days in hospital, strains representing the physiological flora of the patient are replaced by hospital strains highly resistant to antibiotics Dzieranowska, 1999; Malik et al., 1999; Neely et al., 2001 ; . The units with the highest risk of infection are: intensive care unit, neonatal unit, haematology, oncology and surgical units as well as burns units Bronk et al., 1997; Dzieranowska, 1999; Malik et al., 1999; Neely et al., 2001; Ozorowski et al., 2003 ; . The aim of this study was to evaluate the antibiotic resistance of enterococci isolated from clinical specimens of Upper Silesian Health Center of Child and Mother in Katowice. Ninety seven strains of enterococci causing urinary tract infections in patients hospitalized in nephrology 65 ; , pediatrics 9 ; , intensive care, neonatal pathology 11 ; , gastroenterology 12 ; units of the pediatric hospital Health Center of Mother and Child in Katowice were studied. The isolated strains of enterococci were identified by using routine laboratory diagnostic methods and Rapid ID 32 Strep, BioMrieux, France ; biochemical tests. Antibiotic susceptibility of isolated strains was examined by: disc diffusion method for vancomycin, teicoplanin, gentamycin 120 : g ; , streptomycin 300 : g ; and synercid with guidelines of Polish National Center of Bacterial Antibiotic Susceptibility and NCCLS and E-Test method AB Biodisk, Sweden ; MICs for vancomycin, teicoplanin, gentamycin, streptomycin and synercid ; Table I.
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