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References Ambassador Iulian Buga, speech Sep., 2002 CEEBIC Romania Country Commercial Guide. EuroStat, OETH. Federation of Employers Associations in the Light Industry. FEPAIUS statistics "From Comparative Advantage to Damage Control: Clarifying Strategic Issues Using SWOT Analysis, " Nonprofit Management and Leadership, Vol. 3, Fall 1992. Kearns, Kevin P. Foreign Investment Promotion Agency of Bosnia and Herzegovina Harvard Business School, Index of Economic Freedom. The Heritage Foundation Wall Street Journal. "Info Business 2002" Romanian Center for Foreign Trade INSSE Annual Report 2001 Investing in Central and Eastern Europe, Dresdner Bank, May 2002. Harvard Textile Report, May 2003 - Adani, Couton, Joelson, Kugi, Ministry of Industry and Resources website National Institute for Statistics website OCIMM statistics "Plowing the Sea Nurturing the Hiddeen Sources of growth in the Developing World", Fairbanks, Michael & Lindsay, Stace 1997 Romanian Statistical Yearbook 2001.
The other regimen, developed in france, gives 180 mg m² of camptosar on day 1 every 2 weeks; a 400 mg m² iv bolus of 5-fu followed by 600 mg m² continuous infusion on days 1 and 2 every 2 weeks; and 200 mg m2 of leucovorin on days 1 and 2 every 2 weeks.
Terri Arledge, US Department Head, Drug Development Genetics, Glaxo Smith Kline, Moore Drive, Research Triangle Park, North Carolina, USA Pharmacogenetics holds the promise of personalized therapy. We envision a day when physicians can use pharmacogenetic data rather than population data to make more informed decisions about therapy. Physicians will be more likely to identify patients who can best respond to medicines in the situations where differences in medicine response can be explained by genetic variability. Pharmacogenetics is a new tool for drug development. While this is a powerful new tool, it will be added to, rather than replace, the already existing methods of drug evaluation PK, PD, etc ; . We expect to work within the regulatory foundation that already exists specifically one built on strong science - i.e. reproducibility, good clinical and laboratory practices; all of the ethical understandings we already have for drug development, including maintaining confidentiality of patient data. How do we in industry envision the steps to take us from dream to reality? Hypothesis generation is the first step. This means that any genes that could possibly be involved in a drug's response are listed. Response is used here in the broadest sense - genes involved in absorption distribution metabolism excretion pathways, target receptors, genes involved in the drug's mechanism of action. At this stage an initial relationship between a response to drug and a specific genotype s ; would be identified for further investigation. With the availability of SNP maps, individual genes would not have to be identified. Instead it will be possible to look at SNP profiles and compare this to medicine response in order to identify subpopulations of patients who have differing benefit: risk assessments for a given drug. We may not ever need to know the underlying science behind the differences in SNP profiles and how they give rise to different responses to certain medicines. It may be enough to know that there is an association between a given profile and a response to medicine. Further study, of course, could yield valuable information for the development of similar medicines in the drug development pipeline. Once a pharmacogenetic relationship to medicine response is identified in drug development, this needs to be confirmed. Having a certain result in a pharmacogenetic test or medicine response profile test ; could become part of the selection criteria for including patients in confirmatory trials. Pharmacogenetics may allow sponsors to prove efficacy on a much smaller population of patients. For example, if a subgroup of patients were identi.
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Ment of OVX rats with either PTH alone or bFGF and PTH had no effect on Tb.N. However, treatment of OVX rats with either estrogen, bFGF, and PTH or with risedronate, bFGF, and PTH increased Tb.N relative to that in OVX rats treated with vehicle and OVX rats treated with PTH alone. Trabecular separation Tb.Sp ; was greater in vehicletreated OVX rats than in vehicle-treated sham rats Fig. 1D ; . Treatment of OVX rats with PTH alone tended to decrease Tb.Sp, but statistical significance was not achieved. However, treatment of OVX rats with bFGF and PTH; estrogen, bFGF, and PTH; or risedronate, bFGF, and PTH resulted in lower Tb.Sp than in OVX rats treated with either vehicle or PTH alone. The N.Nd and Nd.Nd were lower in vehicle-treated OVX rats than in vehicle-treated sham rats Table 3 ; . Treatment of OVX rats with PTH alone had no effect on N.Nd or Nd.Nd, whereas treatment of OVX rats with bFGF plus PTH increased both end points above those observed in OVX rats.
Camptosar is the first new agent approved by the Food and Drug Administration for the treatment of advanced colorectal cancer in 40 years. The drug, previously known as CPT-11, is a derivative of camptothecin, a chemical isolated from the stem wood of the Chinese tree camptotheca acuminata. Camptothecin was shown in early clinical trials to have antitumor activity, but also to have severe and unpredictable toxicities. In the mid 1980s, camptothecin was shown to be a potent inhibitor of the nuclear enzyme topoisomerase I topo I ; .This understanding of the unique mechanism of action led to a flurry of investigations aimed at identifying water-soluble derivatives of camptothecin which would retain or improve upon its clinical activity and which would have more manageable and predictable toxicities. Two such derivatives have now reached the market: topotecan Hycamtin ; and irinotecan CPT-11, or Camptosar ; . It is important to recognize that these camptothecin derivatives do not necessarily share the same spectrum of activity. Topotecan, which is approved for use in cisplatin-refractory ovarian carcinoma, is essentially inactive in colorectal cancer. Irinotecan, or Camptosar, on the other hand, is highly active in colorectal cancer. In one study done by our group at Memorial Sloan-Kettering Cancer Center, 32% of colorectal patients with no prior chemotherapy achieved a major 50% ; reduction in tumor size. Perhaps as importantly, roughly 20% achieved a more modest tumor regression and another roughly 20% achieved a stabilization of disease, with only about a quarter of the patients treated showing overt progression of disease. In a trial published from the University of Texas, San Antonio, a 23% major objective response rate was reported in patients whose disease had progressed through 5-FU-based therapy. This antitumor activity in previously treated patients has led to Camptosar's current approved clinical indication. The standard treatment regimen for Camptosar in North America involves 90 minute intravenous infusions of 125 mg m2 weekly for four consecutive weeks followed by a two-week rest. More rapid intravenous infusions at this dose may lead to acute cholinergic reactions resulting in early-onset diarrhea. This type of cholinergic reaction, involving diarrhea and or diaphoresis in the period during.
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Kenneth J. Ottenbacher Epidemiologic and public health researchers frequently include several dependent variables, repeated assessments, or subgroup analyses in their investigations. These factors result in multiple tests of statistical significance and may produce type 1 experimental errors. This study examined the type 1 error rate in a sample of public health and epidemiologic research. A total of 173 articles chosen at random from 1996 issues of the American Journal of Public Health and the American Journal of Epidemiology were examined to determine the incidence of type 1 errors. Three different methods of computing type 1 error rates were used: experimentwise error rate, error rate per experiment, and percent error rate. The results indicate a type 1 error rate substantially higher than the traditionally assumed level of 5% p 0.05 ; . No practical or statistically significant difference was found between type 1 error rates across the two journals. Methods to determine and correct type 1 errors should be reported in epidemiologic and public health research investigations that include multiple statistical tests. J Epidemiol 1998; 147: 615-19. bias epidemiology probability; research design; significance tests.
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5: 06PM JO.00008 Computational study on the statistics of turbulent pipe flow , XIAOHUA WU, Royal Military College of Canada, PARVIZ MOIN, Stanford University -- Fully developed turbulent pipe flow at ReD 44000 was simulated with finite difference method on 630 million grid points. The corresponding pipe radius R based Karman number R + is 1142 and the domain length is 15R. Simulation results agree well with the experimental data of Lawn 1971 ; , Zagarola et al 1997 ; and McKeon et al 2004 ; . Near the wall the gradient of lnU + with respect to ln 1 - approximately constant for the narrow region of 70 1 - 120. Thus the DNS is consistent with the limited power-law of Zagarola et al for R + 5000. Similarly, the near-wall gradient of U + with respect to ln 1 - can only be considered constant for 50 1 - r ; thereby indicating limited log-law. The gradient of U with respect to 1 - r ReD 44000 is found to nearly collapse with that at ReD 5300 for the central region of 1 - r 0.4. An explanation for the existence of logarithmic mean pipe flow velocity profile even at very low Reynolds numbers is given. Budgets of the mean axial velocity balance show that at ReD 44000 only within a very narrow range of approximately 10 wall units 0.003 1 - r 0.015 ; do the effects of viscous shear stress gradient and turbulent shear stress gradient overwhelm other contributions. Away from the pipe surface for 1 - r 0.2 all terms in the mean axial momentum transport equation remain nearly unchanged. Flow visualizations at both Reynolds numbers will also be presented. 5: 19PM JO.00009 Large eddy simulation of flow around a three-dimensional model vehicle1 , JUNG-IL LEE, HAECHEON CHOI, Seoul National University, NOMA PARK, Univ. of Minnesota -- Large eddy simulation of turbulent flow around a threedimensional model vehicle is conducted at Re 170, 000 based on the vehicle height. The three-dimensional shape of this model vehicle is realized by an immersed boundary method in a Cartesian coordinate Kim et al., JCP 2001 ; . As a subgrid-scale SGS ; model, we consider the Smagorinsky and Vreman Vreman, PoF 2004 ; models with constant model coefficients Cs 0.16 and Cv 0.07, respectively ; , and a dynamic Vreman model developed by Park et al. PoF 2006 ; . The issue on how to dynamically obtain the Vreman model coefficient is re-investigated based on the Germano identity and the global equilibrium between the SGS dissipation and viscous dissipation. The results of simulations are compared with the experimental results by Khalighi et al. SAE 2001 ; and will be shown in the final presentation.
Researchers from the university of alabama reported the results of treating 16 patients with extensive disease sclc with camptosar eloxatin cancer consultants press release ; , debiopharm and nanocarrier sign license and supply agreement for and carbenicillin
Tween interstitial glucose and blood glucose measured in human subjects. Diabetes Care 26: 24052409, 2003 Flamm CR: Use of intermittent or continuous interstitial glucose monitoring in patients with diabetes mellitus. Technology Evaluation Center. Blue Cross and Blue Shield Association Assessment Program. Vol. 18, No. 16. December 2003 Goldstein DE, Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM: Tests of glycemia in diabetes. Diabetes Care 18: 896 909, The Diabetes Research in Children Network DirecNet ; Study Group: A randomized multicenter trial comparing the GlucoWatch Biographer with standard glucose monitoring in children with type 1 diabetes. Diabetes Care 28: 1101 1106, Larsen J, Ford T, Lyden E, Colling C, Mack-Shipman L, Lane J: What is hypoglycemia in patients with well-controlled type 1 diabetes treated by subcutaneous insulin pump with use of the continuous glucose monitoring system? Endocr Pract 10: 324 329, Nyback-Nakell A, von Heijne M, Adamson U, Lins PE, Landstedt-Hallin L: Accuracy of continuous nocturnal glucose screening after 48 and 72 hours in type 2 diabetes patients on combined oral and insulin gherapy. Diabetes Metab 30: 517 521, Buhling KJ, Kurzidim B, Wolf C, Wohlfarth K, Mahmoudi M, Wascher C, Siebert G, Dudenhausen JW: Introductory experience with the continuous glucose monitoring system CGMS; Medtronic Minimed ; in detecting hyperglycemia by comparing the self-monitoring of blood glucose SMBG ; in non-pregnant women and in pregnant women with impaired glucose tolerance and gestational diabetes. Exp Clin Endocrinol Diabetes 112: 556 560, Schwing WD, Erhard P, Newman LN, Nodge MM, Czechanski BJ, Orlin SM, Walden SM, Behm K, Cacho CP, Negrea LA, Siu DS, Kern EO, Weiss MF: Assessing 24-hour blood glucose patterns in diabetic patients treated by peritoneal dialysis. Adv Perit Dial 20: 213216, 2004 DeVries JH, Wentholt IM, Masurel N, Mantel I, Poscia A, Maran A, Heine RJ: Nocturnal hypoglycaemia in type 1 diabetes-- consequences and assessment. Diabetes Metab Res Rev 20 Suppl. 2 ; : S43 S46, 2004 Diem P, Kalt L, Haueter U, Krinelke L, Fajfr R, Reihl B, Beyer U: Clinical performance of a continuous viscometric affinity sensor for glucose. Diabetes Technol Ther 6: 790 799.
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Camptothecins are an important class of anti-cancer drugs introduced in recent years; however, the marketed camptothecin analogs, irinotecan camptosar ; and topotecan hycamtin ; , have demonstrated limitations that may reduce their clinical utility and carboplatin.
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Fig. 8 hTERT-transduced T cells are more resistant to oxidative stress than untransduced cells. Untransduced and hTERT-transduced cells of Th1 Th0-like clone MoT-81, Th2 clone BOY JF157 or CD8 + clone AKR103 taken two weeks after stimulation, were depleted of dead cells and treated with H2O2 at the indicated concentrations in the presence of FeSO4 and rhIL-2. The presence of apoptotic cells was analyzed after 5h, 24h or 48h of incubation by Annexin V binding. In parallel cultures, apoptosis was induced by treatment with dexamethasone. Graphs show the percentage of Annexin V positive and 7AAD negative apoptotic ; cells after overnight incubation. a, Percentage of apoptotic cells of clone MoT-81 after 48h of incubation left panel ; , and clone AKR103 after 24h of incubation right panel ; . Graphs show representative results of two MoT-81 ; or three AKR103 ; independent experiments. Lower graphs indicate the percentage of apoptosis induced by dexamethasone treatment b, Average percentage of apoptotic cells and standard deviation of CD4 + BOY JF157 T cells after 24h left graph ; or 48h right graph ; of incubation with H2O2, as measured in three independent experiments and camptosar.
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On February 10, 2004 we completed the acquisition of all of the outstanding shares of Esperion Therapeutics, Inc. Esperion ; , a biopharmaceutical company, with no approved products, that is focused on the development of HDL cholesterol-targeted therapies for the treatment of cardiovascular disease, for .3 billion in cash including transaction costs ; . The acquisition has been accounted for as a purchase business combination. The allocation of the purchase price includes IPR&D of 0 million, which was expensed and is included in Merger-related in-process research and development charges, and goodwill of 0 million, which has been allocated to our Human Health segment. Neither of these items is deductible for tax purposes. On September 30, 2004, we completed the acquisition of Campto irinotecan ; , a marketed product for the treatment of advanced colorectal cancer, from Sanofi-Aventis for 0 million in cash. Additional payments of up to million will be payable upon obtaining regulatory approvals for additional indications in certain European countries. Through this business acquisition, we now have the right to market Campto sold under the name Camptosar in the Americas and Australia ; on an expanded worldwide basis. In connection with the acquisition, we recorded an intangible asset for developed technology rights of 5 million. In 2004, we also completed several other acquisitions. The total purchase price associated with these transactions, was approximately 0 million. In connection with these transactions we expensed 1 million of IPR&D, which was included in Merger-related in-process research and development charges, and recorded 6 million in intangible assets, primarily brands indefinite-lived ; and developed technology rights and carteolol.
TABLE 2. Summary of quality of life assessments between patients in remission with and without joint complaints and controls.
This announcement informs you of the recent FDA clearance of a genetic test that can be used to identify patients at risk for toxicity when treated with Camptosar r ; irinotecan ; . Full prescribing information for Camptosar r ; , including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at fda.gov cder foi label 2005 020571s024, 027, . The Invader UGT1A1 Molecular Assay cleared by FDA is an in vitro diagnostic test for the detection and genotyping of the UGT1A1 gene in genomic DNA from peripheral blood. The diagnostic test is marketed by Third Wave Technologies, Inc. Uridine diphosphate glucuronosyltransferase 1A1 UGT1A1 ; is the principle enzyme that inactivates SN-38, the active moiety of irinotecan. Camptosar r ; irinotecan hydrochloride injection ; is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum and for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Camptosar r ; is also approved in combination with Erbitux r ; for the treatment of epidermal growth factor receptor EGFR ; -expressing, metastatic colorectal carcinoma. The active form of Camptosar r ; , SN-38, is metabolized by the polymorphic enzyme UGT1A1. UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity such as the UGT1A1 * 28 polymorphism. Approximately 10% of the North American population is homozygous for the UGT1A1 * 28 allele. Patients with reduced UGT1A1 activity are at an increased risk of experiencing grade 4 neutropenia when treated with Camptosar r ; . The newly cleared diagnostic detects the UGT1A1 * 1 normal ; and the UGT1A1 * 28 variant ; alleles. The test is conducted using whole peripheral blood. The recently approved Camptosar r ; label recommends a lower starting dose for patients who are homozygous for the UGT1A1 * 28 allele and indicates an increased risk for neutropenia for patients with reduced UGT1A1 activity. The cleared diagnostic test will help to determine appropriate dosing for patients homozygous for UGT1A1 * 28 allele and caverject.
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Irinotecan camptosar conversion to regular approval - treatment of metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-fu-based therapy and capecitabine.
1 Garner P, Kale R, Dickson R, Dans T, Salinas R. Implementing research findings in developing countries. BMJ 1998; 317: 531-5. August. ; 2 Gibbs T, Mulka O, Zaremba E. The Royal College of General Practitioners Ukraine fellowship programme 19931997. Eur J Gen Pract 1998; 4: 84-7. Kromhout D, Bloemberg B, Doornbos G. Reversibility of rise in Russian mortality rates. Lancet 1997; 350: 379 and cefazolin.
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