Library

X
feed icon rss

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 1
    Electronic Resource
    Electronic Resource
    Becaplermin gel in the treatment of pressure ulcers: a phase II randomized, double-blind, placebo-controlled study (1999)
    Oxford, UK : Blackwell Science Inc
    Wound repair and regeneration 7 (1999), S. 0 
    Details
    ISSN: 1524-475X
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Pressure ulcers are associated with significant rates of morbidity and mortality, particularly in the geriatric and spinal cord–injured populations. Newer pharmacologically active therapies include the use of topically applied recombinant human platelet-derived growth factor-BB (becaplermin), the active ingredient in REGRANEX® (becaplermin) Gel 0.01%, which has been approved in the United States for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. In this study, the efficacy of becaplermin gel in the treatment of chronic full thickness pressure ulcers was compared with that of placebo gel. A total of 124 adults (≥ 18 years of age) with pressure ulcers were assigned randomly to receive topical treatment with becaplermin gel 100 μg/g (n = 31) or 300 μg/g (n = 32) once daily alternated with placebo gel every 12 hours, becaplermin gel 100 μg/g twice daily (n = 30), or placebo (sodium carboxymethylcellulose) gel (n = 31) twice daily until complete healing was achieved or for 16 weeks. All treatment groups received a standardized regimen of good wound care throughout the study period. Study endpoints were the incidence of complete healing, the incidence of ≥ 90% healing, and the relative ulcer volume at endpoint (endpoint/baseline). Once-daily treatment of chronic pressure ulcers with becaplermin gel 100 μg/g or 300 μg/g significantly increased the incidences of complete and ≥ 90% healing and significantly reduced the median relative ulcer volume at endpoint compared with that of placebo gel (p 〈 0.025 for all comparisons). Becaplermin gel 300 μg/g did not result in a significantly greater incidence of healing than that observed with 100 μg/g. Treatment with becaplermin gel was generally well tolerated and the incidence of adverse events was similar among treatment groups. In conclusion, once-daily application of becaplermin gel is efficacious in the treatment of chronic full thickness pressure ulcers.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1524-475X.1999.00141.x
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 2
    Electronic Resource
    Electronic Resource
    Efficacy and safety of becaplermin (recombinant human platelet-derived growth factor-BB) in patients with nonhealing, lower extremity diabetic ulcers: a combined analysis of four randomized studies (1999)
    Oxford, UK : Blackwell Science Inc
    Wound repair and regeneration 7 (1999), S. 0 
    Details
    ISSN: 1524-475X
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: The results of a combined analysis and separate analyses of four multicenter, randomized, parallel group studies that evaluated the effects of once-daily topical administration of becaplermin gel for the treatment of chronic, full thickness, lower extremity diabetic ulcers are presented. The four studies included a total of 922 patients with nonhealing lower extremity diabetic ulcers of at least 8 weeks' duration. Following initial complete sharp debridement of the ulcer, patients were randomized to receive a standardized regimen of good ulcer care alone, good ulcer care plus placebo gel, or good ulcer care plus becaplermin gel-30 μg/g, or good ulcer care plus becaplermin gel-100 μg/g, with various combinations of regimens used in the four studies. Safety was assessed by monitoring adverse events and by clinical laboratory evaluations. Meta-analytic statistical techniques were used in the combined analysis to establish homogeneity of treatment comparisons across studies. Based on an analysis of patients with baseline ulcer area common to all trials (≤ 10 cm2), representing 95% of all patients, becaplermin gel-100 μg/g significantly increased (p = 0.007) the probability of complete healing compared with placebo gel. It was determined that for the median ulcer area of these patients, which was 1.5 cm2, the becaplermin gel-100 μg/g treatment group showed a 39% increase in complete healing compared with that of the placebo gel treatment group (50% vs. 36%, respectively, p = 0.007). Becaplermin gel-100 μg/g significantly decreased (p = 0.01) the time to complete healing compared with placebo gel, with the 35th percentile of time to complete healing being reduced by 30% (14.1 weeks vs. 20.1 weeks, respectively). In patients with ulcers ≤ 5 cm2 at baseline (a more homogeneous group), becaplermin gel-100 μg/g also significantly increased the incidence of complete healing with a similar decrease in the time to healing. Adverse events reported during treatment or during a 3-month follow-up period were not unexpected for this patient population and were similar in nature and incidence across all treatment groups. We therefore conclude that treatment with becaplermin gel at a dose of 100 μg/g once daily, in conjunction with good ulcer care, is effective and well tolerated in patients with full thickness lower extremity diabetic ulcers.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1524-475X.1999.00335.x
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 3
    Electronic Resource
    Electronic Resource
    The dilemmas of citizenship: Limitations on canadian legal rights (1996)
    Springer
    Critical criminology 7 (1996), S. 17-36 
    Details
    ISSN: 1572-9877
    Source: Springer Online Journal Archives 1860-2000
    Topics: Law
    Notes: Abstract Since the entrenchment of the Canadian Charter of Rights and Freedoms, Canadian courts have been burdened with a disproportionate number of cases concerned with issues arising from the newly introduced legal rights. However, the transition from the Canadian crime-control model to the American-style due-process model is far from complete. The rights of the accused are consistently deemed to be secondary to the aim of reinforcing the legitimacy of the criminal justice system. Canadians' legal rights will in fact remain limited as long as judges continue to decide cases on the basis of harm done to the justice system, rather than individuals and groups.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02461092
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 4
    facet.materialart.
    Unknown
    The role of popular mobilizations in the struggle for the Canadian Charter of Rights and Freedoms (1994)
    Dordrecht, etc. : Periodicals Archive Online (PAO)
    Crime, Law and Social Change. 22:3 (1994/1995) 183-212 
    Details
    ISSN: 0925-4994
    Topics: Law
    URL: http://gateway.proquest.com/openurl?url_ver=Z39.88-2004&res_dat=xri:pao:&rft_dat=xri:pao:article:v533-1994-022-03-000001
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 5
    facet.materialart.
    Unknown
    Criminal victimization in the industrialized world (1994)
    Dordrecht, etc. : Periodicals Archive Online (PAO)
    Crime, Law and Social Change. 21:2 (1994) 155 
    Details
    ISSN: 0925-4994
    Topics: Law
    Notes: Review essays
    URL: http://gateway.proquest.com/openurl?url_ver=Z39.88-2004&res_dat=xri:pao:&rft_dat=xri:pao:article:v533-1994-021-02-000003
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 6
    Electronic Resource
    Electronic Resource
    Criminal victimization in the industrialized world (1994)
    Springer
    Crime, law and social change 21 (1994), S. 155-165 
    Details
    ISSN: 1573-0751
    Source: Springer Online Journal Archives 1860-2000
    Topics: Law
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01307909
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 7
    Electronic Resource
    Electronic Resource
    The role of popular mobilizations in the struggle for the Canadian Charter of Rights and Freedoms (1994)
    Springer
    Crime, law and social change 22 (1994), S. 183-212 
    Details
    ISSN: 1573-0751
    Source: Springer Online Journal Archives 1860-2000
    Topics: Law
    Notes: Abstract In spite of the best efforts of Canada's first ministers, the debate leading up to the enactment of the Canadian Charter of Rights and Freedoms was characterized by the mobilization of several demanding factors of the Canadian populace. The Hays-Joyal hearings on the Constitution provided a formal setting for popular participation, and in fact drew submissions from a variety of special interest groups. Significantly, the minimal class representation in both the formal and informal processes of Charter construction was in stark contrast to the militant interventions of women's and Native's lobbies. In spite of the resistance of the politicians, and in spite of internal weaknesses, these movements were able to impose some elements of their collective demands on the otherwise limited vision of rights in Canada. Their voices were in fact heard over the din of federal-provincial squabbling.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01299285
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 8
    Electronic Resource
    Electronic Resource
    Biopharmaceutical Approaches for Developing and Assessing Oral Peptide Delivery Strategies and Systems: In Vitro Permeability and In Vivo Oral Absorption of Salmon Calcitonin (1999)
    Springer
    Pharmaceutical research 16 (1999), S. 527-533 
    Details
    ISSN: 1573-904X
    Keywords: permeability ; bioavailability ; rats ; dogs ; humans ; oral delivery ; peptides ; and salmon calcitonin
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Purpose. To evaluate a biopharmaceutical approach for selecting formulation additives and establishing the performance specifications of an oral peptide delivery system using sCT as a model peptide. Methods. The effect of formulation additives on sCT effective permeability and transepithelial electrical resistance (TEER) was evaluated in side-by-side diffusion chambers using rat intestinal segments. Baseline regional oral absorption of sCT was evaluated in an Intestinal and Vascular Access Port (IVAP) dog model by administration directly into the duodenum, ileum, and colon by means of surgically implanted, chronic catheters. The effect of varying the input rate and volume of the administered solution on the extent of sCT absorption was also evaluated. Citric acid (CA) was utilized in all studies to cause a transient reduction in local pH. In vitro samples and plasma samples were analyzed by radioimmunoassay (RIA). Two oral delivery systems were prepared based on the results of the in vitro and IVAP studies, and evaluated in normal dogs. Results. Maximal permeability enhancement of sCT was observed using taurodeoxycholate (TDC) or lauroyl carnitine (LC) in vitro. Ileal absorption of sCT was higher than in other regions of the intestine. Low volume and bolus input of solution formulations was selected as the optimal condition for the IVAP studies since larger volumes or slower input rates resulted in significantly lower sCT bioavailability (BA). Much lower BA of sCT was observed when CA was not used in the formulation. The absolute oral bioavailability (mean ± SD) in dogs for the control (sCT + CA) and two proprietary sCT delivery systems was 0.30% ± 0.05%, 1.10 ± 0.18%, and 1.31 ± 0.56%, respectively. Conclusions. These studies demonstrate the utility of in vitro evaluation and controlled in vivo studies for developing oral peptide delivery strategies. Formulation additives were selected, the optimal intestinal region for delivery identified, and the optimal release kinetics of additives and actives from the delivery system were characterized. These methods were successfully used for devising delivery strategies and fabricating and evaluating oral sCT delivery systems in animals. Based on these studies, sCT delivery systems have been fabricated and tested in humans with favorable results.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1018819012405
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 9
    Electronic Resource
    Electronic Resource
    Regional Differences in Intestinal Spreading and pH Recovery and the Impact on Salmon Calcitonin Absorption in Dogs (2000)
    Springer
    Pharmaceutical research 17 (2000), S. 284-290 
    Details
    ISSN: 1573-904X
    Keywords: intestinal motility ; regional pH ; oral absorption ; peptide drugs ; salmon calcitonin ; IAP dogs
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Purpose. To investigate the regional influence of intestinal spreadingand pH recovery on the performance of drug and excipient deliverysystems and their impact on the oral absorption of a model peptidedrug, salmon calcitonin (sCT), in conscious beagle dogs. Methods. Male beagle dogs were surgically prepared with subdermalIntestinal Access Ports (IAP). The catheter from one port was placedin the duodenum and the other in the ileum. Fluoroscopy and HeidelbergpH capsule studies were performed to characterize intestinal spreadingand pH recovery, respectively. Three treatments were performed: (1)a radiopaque dye and citric acid (CA) were infused into the intestinalsegments, (2) a radiopaque powder capsule containing CA was givenorally, and (3) capsules containing CA and sCT were given orally.Regular blood samples were collected and analyzed byradioimmunoassay (RIA) to determine the absorption characteristics of sCT. Results. Since sCT is an excellent substrate for the pancreatic serineprotease trypsin, the rate of degradation of sCT in the GI lumen isdependent upon the regional pH, activity of digestive enzymes and theconcentration of sCT at the site of absorption. Fluoroscopy resultsclearly showed that when the radiopaque dye was infused into theduodenum and capsule disintegration occurred early, there wassignificant dilution and spreading of the excipients throughout a large sectionof the upper small intestine (USI). However, when the radiopaque dyewas infused into the ileum and capsule disintegration occurred in thelower small intestine (LSI), the excipients moved along as a bolus (i.e.,plug). The pH monitoring results were consistent with the fluoroscopyresults. The pH dropped only momentarily and rose quickly in the USIconsistent with well-stirred mixing kinetics. In the LSI, dilution andspreading were minimal and the drop in pH was greater and persistedfor a longer period of time. Plasma levels of sCT were maximal whendisintegration occurred in the LSI. Conclusions. Since significantly less dilution and spreading occurredin the LSI, the exposure of the intestine to pharmaceutical excipientsand sCT was more concentrated resulting in a higher fraction of sCTabsorbed. The results of this study demonstrate that intestinal mixingkinetics have a dramatic impact on the ability of pharmaceuticalexcipients to modulate the oral bioavailability of peptide drugs like sCT.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1007596821702
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 10
    Electronic Resource
    Electronic Resource
    Impact of Regional Intestinal pH Modulation on Absorption of Peptide Drugs: Oral Absorption Studies of Salmon Calcitonin in Beagle Dogs (1999)
    Springer
    Pharmaceutical research 16 (1999), S. 1233-1239 
    Details
    ISSN: 1573-904X
    Keywords: intestinal pH recovery ; oral absorption ; peptide drugs ; salmon calcitonin ; dogs
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Purpose. To investigate the relationship between the modulation of intestinal pH and the oral absorption properties of a model peptide drug, salmon calcitonin (sCT), in conscious beagle dogs. Methods. Studies were performed to characterize the disintegration of the formulation, intestinal pH changes, and the appearance of the peptide in the blood. Enteric-coated formulations containing sCT and various amounts of citric acid (CA) were tethered to a Heidelberg capsule (HC) and given orally to normal beagle dogs. Blood samples were collected and analyzed by radioimmunoassay (RIA). Intestinal pH was continuously monitored using the Heidelberg pH capsule (HC) system. The integrity of the HC-delivery system tether was verified by fluoroscopy. Results. The intra-individual variation in gastric emptying (GE) of the delivery system was large. There were also large inter-individual differences in the disintegration and absorption properties of the various formulations. However, the peak plasma concentrations of sCT were always observed when the intestinal pH declined. The average baseline intestinal pH was 6.1 ± 0.2 (mean ± SEM, n = 12). The intestinal pH reduction was 2.6 ± 0.4 (mean ± SEM, n = 12, ranged from 0.5 to 4.0 units from baseline). There was a good correlation between the time to reach the trough intestinal pH (tpH,min) and time to reach the peak plasma concentration (tconc,max) of sCT (tconc,max = 0.95 × tpH,min + 14.1, n = 11, r2 = 0.91). Plasma Cmax and area under the curve (AUC) increased with increasing amounts of CA in the formulations. Conclusions. The results of these studies demonstrate that the oral absorption properties of a model peptide drug, sCT, can be modulated by changing intestinal pH. sCT is a substrate for the pancreatic serine protease trypsin which has maximal activity at pH 5 to 6. Reducing intestinal pH presumably stabilizes sCT in the GI tract enabling greater absorption of the intact peptide.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1014849630520
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...