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New Product Approvals During fiscal 1998, 13 approvals were received from the FDA. The Company presently has requests for approval pending before the FDA representing 28 products of varying strengths. Subsequent to March 31, 1998, the Company received two additional ANDA approvals and a New Drug Application approval for its wound care product, Sulfamylon R ; . In addition the Company has five IND applications filed with the FDA for new innovator compounds. Customers and Markets The Company sells its products to proprietary and ethical pharmaceutical wholesalers and distributors, drug store chains, drug manufacturers and public and governmental agencies. In fiscal 1998, three customers accounted for approximately 13%, 12%, and 11% of net sales, respectively. Although no single customer represented more than 10% of net sales in fiscal 1997 or 1996, four customers in 1997 represented 36% of net sales. A majority of the Company's products are marketed to food and drug store chains and to pharmaceutical distributors and wholesalers, that in turn market to retailers, managed care entities, hospitals and government agencies. Certain other products are marketed to institutional accounts that in turn obtain the products from pharmaceutical distributors and wholesalers. The Company's sales activities involve limited public promotion of its products. Approximately 205 employees of the Company are engaged full-time in selling products and servicing customers. Competition The Company sells to various markets and classes of customers. With respect to each of the products it sells, the Company believes it is subject to active competition from numerous firms. The four primary means of competition are service, product quality, FDA approval and price. The competition experienced by the Company varies among the markets and classes of customers. The Company has experienced additional competition from brand-name competitors that have entered the generic pharmaceutical industry by creating generic subsidiaries, purchasing generic companies or licensing their products prior to or as their patents expire. In addition to the increase in the number of competitors, the consolidation of the Company's customers through mergers and acquisitions along with the emergence of large buying groups representing independent pharmacies and health maintenance organizations has also contributed to the severe price deterioration for the Company's generic products. While the Company has increased unit volume of its generic products through specialized marketing programs, this has not fully offset the price declines the Company has experienced.
The cerebro-cerebral commissure and viscero-parietal connective. Stimuli delivered to the left-hand side cannot now enter the right-hand side of the brain without passing through the pedal ganglion. Fig. 6 shows the sort of result obtained in this type of experiment. In these experiments, responses are only rarely abolished, but those that are made can be classified into one of two types. Primary responses Fig. 6 A, B, C, D ; are similar to those normally produced before any connectives are cut. They have a short latency and are, initially at least, of large amplitude. Secondary responses Fig. 6E, F ; are elicited from animals in which the pleuro-pedal connectives have been cut. They are of long, variable latency and of low amplitude when compared to the primary responses of the same animal. Similar results have been obtained stimulating the left pallial nerve 13 ; . The results of this series of experiments are summarized in Fig. 7, and the major conclusions to be drawn are, first, that the pleuropedal connectives are of paramount importance in the mediation of normal primary ; responses, and, secondly, that the pathway is response specific, i.e. the same pedal connective is concerned, irrespective of the nerve stimulated, provided that it did not enter the pedal ganglion directly.
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Porcine intestinal mucosal heparin sodium salt, grade I-A ; , chondroitin sulfate A from bovine trachea ; , chondroitin sulfate B dermatan sulfate, from bovine mucosa ; , chondroitin sulfate C from shark cartilage ; , fucoidan from Fucus vesiculosus ; , and HS from bovine intestinal mucosa HSBI ; and from bovine kidney HSK ; , were all purchased from SigmaAldrich Poole, U.K. ; . Before use, heparin was exhaustively dialysed against initially 1 M NaCl and subsequently deionised water before freeze drying. Two HS isolated from porcine intestinal mucosa, HSA and HSE, were kindly provided by Dr. B. Mulloy NIBSC, Hertfordshire, U.K. ; . HSA and HSE have Mr of 20 kDa and 8 kDa; sulfate to carboxylate ratios of 1 and 1.7; and, N-acetyl to carboxylate ratios of 0.6 and 0.2, respectively 15 ; . The clinical low m.w. heparins, Fragmin KabiVitrum, Stockholm, Sweden ; , Fraxiparine Sanofi Chimie, Notre Dame de Bondeville, France ; , and Tinzaparin Logiparin, Novo Nordisk, Gentofte, Denmark ; were obtained from their respective suppliers. Human serum albumin 99% purity ; and p-nitrophenol phosphate FAST tablets were purchased from Sigma-Aldrich. Nunc Maxisorp ELISA plates were obtained from Life Technologies Paisley, Scotland.
London region Rachel Stretch - Preregistration Training Manager London Pharmacy Education & Training Regional Pharmacy Offices, LG floor Chelsea & Westminster Hospital 369 Fulham Road London SW10 9NH South and West Yorkshire region Julie Sowter - Programme Manager Baines Wing, Room 2.25a University of Leeds PO Box 214 Leeds LS2 9UT Scotland National ; Anne Watson - Assistant Director NHS Education for Scotland Pharmacy ; 3rd Floor, 2 Central Quay 89 Hydepark Street Glasgow G3 8BW
CML cells. It was postulated that while the bone marrow of patients with CML is overwhelmed by the growth advantage of the Ph-positive CML cells, a suppressed normal stem cell pool persisted, which could be exploited therapeutically. Treatments that reversed the growth advantage in favor of normal over Ph-positive cells would hopefully change the course of CML, and improve patient prognosis. Preclinical models have established the causal association between the Ph-associated molecular events and the initiation and perpetuation of CML In one such model, c-DNA encoding p2 1 OBCR-ABLwas introduced into mouse marrow cells, which were reinfused into lethally irradiated mice. After 2 to 8 weeks, some of the mice developed CML-like disorders, including 1 ; leukocytosis and splenomegaly, 2 ; monocyte and macrophage extramedullary tu.
5-reductase assay in vitro II ; Prostate tissues were pulverized in liquid nitrogen using mortar and pestle. The pulverized tissue was thereafter homogenized Ellsworth 1995 ; for the metabolic assays. Protein concentration was measured according to Lowry et al Lowry 1951 ; . The assays were based on a method published by Ellsworth and Harris Ellsworth 1995 ; . The 5-reductase activity at pH 5.5 5-reductase 2 ; was assayed in a mixture of 33 mM succinate, 44 mM imidazol, 33 mM diethylamine, 40 mM potassium phosphate pH 5.5, 0.2 nM 14C- testosterone, 1 mM DTT, and 500 M NADPH in a final volume of 100 l. The reaction was started by addition of the enzyme preparation at a final protein concentration of 0.5 mg ml, and then incubated at 37C for 10 min. The 5-reductase activities at pH 7.0 5-reductase 1 ; was analyzed as described above, except for the use of 40 mM potassium phosphate pH 7.0, 1 nM 14C- testosterone and an incubation time of 5 min. The reactions were stopped by extraction with 300 l of a mixture of cyclohexane: ethyl acetate 70: 30 v v ; containing 12 g each of DHT and testosterone. Testosterone was separated from DHT using thin layer chromatography Blanck 1984 ; . The formation of DHT was analyzed using a Phosphor Imager Molecular Dynamics ; that analyzed a scan of the radiation emitted by the radioactive testosterone and the formed metabolite DHT. The assay was validated in terms of linearity with protein concentration, incubation time, and substrate concentration. Taqman allelic discrimination assay III + IV ; In papers III and IV, three Taqman allelic discrimination assays were developed and used. The Taqman methods were based on a PCR- technique with fluorescence detection, first described by Holland et al., 1991 Holland, 1991 ; and reviewed by Livak et al. Livak, 1999 ; . The system consisted basically of a primer pair, two dye-labeled probes, a PCR and a laser detection device. The probes consisted of an allele specific oligonucleotide sequence with a reporter dye R ; FAM 6-carboxy-fluorescein ; or TET 6-carboxy- 4, 7, ; attached in the 5-end as the detection marker. A quencher Q ; , TAMRA 6-carboxy-tetramethyl-rhodamine ; was attached to the 3-end. Theoretically, the probe annealed only to its complementary allele specific sequence. Therefore, as in theses cases with biallelic single nucleotide polymorphisms, the TET probe bound to one allele and the FAM probe to the other. If the DNA was derived from a and tipranavir.
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Description: In December 1999, Horseshoe Carbons Incorporated Horseshoe ; applied to the Ministry of the Environment MOE ; for a certificate of approval CofA ; under Section 9 of the EPA for the discharge of material into the natural environment other than water i.e., air ; . Located in the City of Burlington, Horseshoe operates a plant that reactivates spent activated carbons originating from municipal water treatment plants WTPs ; . The reactivation process involves drying the spent carbon, physically separating any impurities from the spent carbon, and reactivating the carbon through steaming action and sieving. The facility is equipped with a boiler to produce the necessary steam, a rotary drier and a rotary reactivation furnace. Each of these three pieces of equipment has a discharge stack. The building is ventilated by three roof fans, and dust inside the building is controlled by a baghouse dust collector and a multi-cyclone machine. In its December 1999 application, the company initially advised MOE that it would capture between 85-90 per cent of the dust from its carbon dryer and a significant portion of the dust from the kiln. It is apparent that these rates of carbon dust recovery were excessively optimistic. Implications of the Decision: Local residents and some Hamilton residents believe that this approval has significant environmental, health and social implications. They believe that Horseshoe Carbons will release large amounts of carbon compounds, dioxins and furans, suspended particulate matter, heavy metals and volatile organic compounds VOCs ; into the atmosphere, and this may cause soil, air and water contamination with subsequent long-term and cumulative effects on the surrounding area. Local residents also are worried about potential health impacts from the permitted emissions, particularly through the known endocrine disruption and carcinogenic effects of dioxins and furans. They worry that these types of chemicals are released into the atmosphere when the used carbon is heated. In considering these concerns, it is essential to bear in mind that many decisions that might seem small and less significant often have important cumulative environmental effects. Slow deterioration of natural resources and ecosystems because of ongoing discharges of chemical pollutants to air, water and land is a factor that is important and should be considered in the determination of terms and conditions in certificates of approval such as this. Local residents contacted the ECO several times in the spring and summer of 2000, claiming that emissions of carbon dust were much higher than forecast by the and tobi.
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It is important to remember that our large tracer injections into the banks of the cingulate sulcus examined the descending projections from two cortical areas: the CMAd and CMAv. These injections were intentionally made large to label the efferents from these areas as completely as possible. In other animals, we made smaller injections into either bank of the cingulate sulcus to examine separately the efferents from each cortical area. Small tracer injections into either the CMAd or the CMAv resulted in terminations in the intermediate zone and in the ventral horn Fig. 10 ; . Terminations after the CMAd injection were most concentrated in the dorsolateral part of the intermediate zone lateral laminae VVI ; Fig. 10 A ; . contrast, terminations after the CMAv injection were most concentrated in the dorsomedial part of the intermediate zone at the base of the dorsal columns lamina VI ; Fig. 10 B ; . These observations indicate that the pattern of terminations seen after the large CMAd CMAv injections actually represents the sum of two distinct efferent systems. The sparse labeling in the ventral horn after tracer injections into either the CMAd or the CMAv was located dorsolaterally in the lateral cell column. The presence of this labeling, even after small tracer injections, indicates that much of the labeling in the lateral cell column after the CMAd CMAv injections is truly attributable to efferents from these areas and not to spread of tracer to adjacent regions of the SMA. Thus, the CMAd and CMAv both have some input to the lateral motoneuronal cell column in lamina IX Figs. 79.
The effectiveness and safety of unmonitored subcutaneous LMWH riviparin ; in symptomatic pulmonary embolism reported in the COLUMBUS study were confirmed in a study of 612 patients with symptomatic pulmonary embolism reported by Simonneau and associates, 35 who used a different LMWH Tinzaparin ; . Patients who did not require thrombolytic therapy or pulmonary embolectomy were randomly allocated to receive LMWH 175 anti-Xa units kg SC once daily ; or UFH 50 U kg bolus followed by a continuous infusion of 500 U kg 1 adjusted to obtain an APTT ratio of 2.0 to 3.0. The outcome measure, a composite of recurrent thromboembolism, major bleeding, and death, was assessed on days 8 and 90. On day 8, 9 of 308 patients 2.9% ; assigned to UFH and 9 of 304 patients 3.0% ; assigned to LMWH reached at least 1 of the primary end points. By day 90, 22 patients 7.1% ; patients to UFH and 18 patients 5.9% ; assigned to LMWH reached 1 of the primary end points P 0.54 ; Table 6 ; . The rate of major bleeding was similar in both groups 2.6% and 2.0%, respectively ; . There were 3 deaths at 8 days and 14 deaths at 90 days 4.5% ; in patients assigned to UFH and 4 deaths at 8 days and 12 deaths at 90 days 3.9% ; in patients assigned to LMWH. Five deaths were treatment related in the UFH group 3 from pulmonary embolism and 2 from major bleeding ; , and 4 were treatment related in the LMWH group 3 from pulmonary embolism and 1 from bleeding ; . The findings of this study, combined with those of the COLUMBUS study, indicate that subcutaneous weightadjusted LMWH is as effective and safe as intravenous UFH. LMWH, however, is much more convenient. Most of these studies evaluating LMWH preparations for the treatment of venous thromboembolism used a twice-daily weight-adjusted regimen. However, 2 studies, 1 of patients with acute venous thrombosis34 and 1 of patients with acute pulmonary embolism, 35 used a once-daily dose 175 anti-Xa units kg ; of the same LMWH Tinzaparine ; . Both studies and tolcapone.
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Plasma cells, and "smoker's macrophages" Fig. 1C ; . Further evaluation of the histiocytic-appeanng cells with electron microscopy.
With regard to lower total and proximal DVT rates but also a lower incidence of symptomatic DVT. Pooled results of the major total hip replacement trials comparing LMWH with adjusted-dose warfarin also support lower event rates in LMWH-treated patients. 20.7% vs. 13.7% for all DVT; p 0.0002; and 4.8% vs. 3.4% for proximal DVT; p 0.08 ; . Pooled major bleeding rates were numerically higher in the LMWH group than in the warfarin group 5.3% vs. 3.3% ; . Major bleeding rates varied in the individual trials, with some showing no difference between the LMWH and warfarin groups, and some showing trends toward higher bleeding complications in patients treated with LMWH. Dalteparin, enoxaparin, and tinzaparin have all been studied for this indication; however, only the first two have labeled indications approved by the Food and Drug Administration. Fondaparinux, a synthetic factor-Xa inhibitor, also has demonstrated efficacy in patients undergoing total hip replacement compared to enoxaparin in one study. Fondaparinux 2.5 mg day subcutaneously, initiated 48 hours after surgery, was found to be superior to enoxaparin 40 mg day subcutaneously initiated 12 hours before surgery overall VTE 4% vs. 9%; p 0.0001; proximal DVT 1% vs. 2%; p 0.002 ; . A second study that used the same fondaparinux regimen found no difference in efficacy compared to a higher dose of enoxaparin 30 mg subcutaneously 2 times day initiated 1224 hours after surgery. Major bleeding complications were not significantly different between the two groups, though there was a trend of increased overall bleeding in the fondaparinux group. The direct thrombin inhibitors, desirudin and melagatran ximelagatran, also have been compared with LMWHs in patients undergoing total hip replacement with trials showing varied results, depending on the time of initiation and the specific doses of the various drugs. Desirudin is approved by the Food and Drug Administration for this indication but is not yet commercially available; melagatran ximelagatran are neither indicated nor available in the United States. These data suggest that LMWHs are more effective than warfarin, and fondaparinux is more effective than LMWH and likely warfarin based on indirect comparison. The efficacy benefit with the LMWHs and fondaparinux come with a trade-off of slightly higher bleeding rates, especially bleeding at the surgery site or wound hematoma. In addition to the efficacy of LMWHs, additional advantages of those and fondaparinux include their predictable anticoagulant effect and no need for dose adjustment and monitoring, providing for somewhat less complex and more convenient prophylactic regimens. Acquisition costs for LMWH and fondaparinux are higher than for warfarin, pharmacoeconomic studies suggest that when overall costs to the health care system are considered, the costs of these therapies are comparable. However, some patients without drug insurance coverage may find it difficult to pay out-of-pocket for these higher cost alternatives. In addition to the convenience of oral administration, its much lower acquisition cost is what still makes warfarin a frequently prescribed prophylactic alternative after major orthopedic surgery. Unlike LMWHs, fondaparinux has not been linked to heparin-induced thrombocytopenia. However, there are several issues that should be considered when using fondaparinux such as its long half-life about 21 hours ; , lack of a drug to reverse its anticoagulant effect, and a lack of dosing guidelines in patients with renal impairment and in those with very low body weights. Fondaparinux is contraindicated in the latter two populations. An additional consideration in selecting the best prophylactic drug is the type of anesthesia used during the surgical procedure. Due to their shorter half-lives, LMWHs are easier to manipulate around catheter placement and removal times, whereas there are no data for fondaparinux in patients with indwelling epidural catheters. However, great caution also must be applied with the use of LMWH in patients who receive neuraxial anesthesia. In a 1997 public health advisory, the Food and Drug Administration reported 41 cases of perispinal hematoma in patients who received LMWH around the time of spinal epidural anesthesia. The package inserts of LMWHs have a "boxed" warning cautioning the use of these drugs in patients undergoing neuraxial anesthesia. Subsequently, the American Society of Regional Anesthesia has developed guidelines for the use of anticoagulants in these patients. These guidelines take into account the half-lives and dosing regimens of various anticoagulants, and recommend catheter placement and removal at times when the various drugs are at trough concentrations. For a more detailed discussion, the reader is referred to the American Society of Regional Anesthesia Recommendations. ; Total Knee Replacement Surgery Although total knee replacement patients appear to develop lower rates of proximal DVT and symptomatic VTE, the rate of asymptomatic DVT documented by venography is higher than in patients undergoing total hip replacement. Nonpharmacological options for prophylaxis also have been studied in the setting of total knee replacement. Graduated compression stockings and venous foot pumps provide no or only limited VTE protection and, therefore, are not recommended. Data from a few small studies indicate that intermittent pneumatic compression devices may provide adequate benefit; however, as previously discussed, poor compliance and inappropriate use limits their utility. As in patients undergoing total hip replacement, aspirin and LDUH have limited efficacy and are not recommended. Several studies support the use of adjusted-dose warfarin in total knee replacement; however, despite its reported efficacy, a fairly high 2550% ; residual asymptomatic VTE rate is still documented with its use. Furthermore, the complexity of warfarin administration, as previously discussed, needs to be considered. Several studies support the efficacy and safety of LMWHs for this indication. Pooled DVT rates from six large trials that compared LMWH and warfarin in total knee replacement favor LMWHs 33% vs. 48%, respectively ; . In fact, the risk reduction attained with LMWH versus warfarin in patients and tolmetin.
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In a preceding paper Grothe et al., 1997 ; we showed that the MSO of the free-tailed bat contains neurons receiving different combinations of the common MSO inputs Figs. 1 A, 2 ; . Many neurons receive excitatory and inhibitory projections from both ears EI EI ; defined by indirect evidence such as phasic response patterns, nonmonotonic rate-level functions, and low-filter cutoffs for amplitude-modulated stimuli. These response characteristics are abundant in bat MSO neurons but unusual for anteroventral cochlear nucleus AVCN ; bushy cells, the cells that send excitatory projections to MSO Vater, 1982 ; . Additionally, MSO cells frequently show strong inhibitory effects at particular IIDs, which cannot be compensated for by changing ITDs [Grothe et al. 1997 ; , and see below]. Each of the inhibitory effects described above are consistent with the anatomical input patterns to the MSO Grothe et al., 1994, 1997 ; , and they can be blocked pharmacologically in the mustached bat Grothe, 1994 ; and the species used in this study B. Grothe and L. Yang, unpublished results ; . However, there were subpopulations ofcells that failed to show excitatory effects from the ipsilateral ear I EI ; or that failed to show prominent inhibitory effects from both ears E E ; . There were also monaural cells that responded only to one ear. Here we present data from 51 binaural MSO neurons in response to ITDs. In addition, 11 monaural cells were encountered but not included in the analyses below. Furthermore, we recorded from 19 medical nucleus of the trapezoid body MNTB ; and 12 lateral nucleus of the trapezoid body LNTB ; cells to explore the temporal response patterns of the inhibitory MSO inputs. We will turn first to a general description of ITD sensitivity. We then turn to a more specific analysis of the ITD functions found in the different subsets of MSO cells. Differences in the ways that these subgroups respond to ITDs will be used to suggest what role each input plays in ITD coding. Finally, we will propose a simple model of how the excitatory and inhibitory inputs might interact in creating ITD sensitivity. Most data presented were obtained using SAM tones with high-frequency carriers at each neuron's best frequency ; presented as 100 msec stimuli. In some cases.
In domestic ungulates, luteolysis occurring at the end of the estrous cycle is a uterine-dependent event [1], and pulsatile release of uterine prostaglandin PG ; F2 is responsible for inducing luteolysis [2, 3]. Lysis of the corpora lutea and concomitant decline in progesterone production permits further follicular development leading to estrus, ovulation, and the opportunity for mating and pregnancy to occur. The physiological and biochemical mechanisms for regulation of endometrial PGF2 secretion during the estrous cycle in ruminants, especially sheep, have been extensively studied, but the mechanism s ; in swine has not received similar attention and topotecan.
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