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Considerable Experience (considerable + experience)
Selected AbstractsThresholds for food allergens and their value to different stakeholdersALLERGY, Issue 5 2008R. W. R Crevel Thresholds constitute a critical piece of information in assessing the risk from allergenic foods at both the individual and population levels. Knowledge of the minimum dose that can elicit a reaction is of great interest to all food allergy stakeholders. For allergic individuals and health professionals, individual threshold data can inform allergy management. Population thresholds can help both the food industry and regulatory authorities assess the public health risk and design appropriate food safety objectives to guide risk management. Considerable experience has been gained with the double-blind placebo-controlled food challenge (DBPCFC), but only recently has the technique been adapted to provide data on thresholds. Available data thus vary greatly in quality, with relatively few studies providing the best quality individual data, using the low-dose DBPCFC. Such high quality individual data also form the foundation for population thresholds, but these also require, in addition to an adequate sample size, a good characterization of the tested population in relation to the whole allergic population. Determination of thresholds at both an individual level and at a population level is influenced by many factors. This review describes a low-dose challenge protocol developed as part of the European Community-funded Integrated Project Europrevall, and strongly recommends its wider use so that data are generated that can readily increase the power of existing studies. [source] A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revisionJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 7 2010Steven W. Baertschi Abstract The ICH guideline on photostability (ICH Topic Q1B) was published in November 1996 and has been implemented in all three regions (US, EU, and Japan). The guideline describes a useful basic protocol for testing of new drug substances and associated drug products for manufacturing, storage, and distribution, but it does not cover the photostability of drugs under conditions of patient use. The pharmaceutical industry now has considerable experience in designing and carrying out photostability studies within the context of this guideline, and issues have been identified that would benefit from the revision process. The purpose of this commentary is to accomplish the following: (i) highlight issues proposed for consideration in the ICH revision process, (ii) offer a rationale for why these issues may compromise the design of a testing protocol and/or the results of the testing program, and (iii) provide recommendations for clarification of the guideline. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:2934,2940, 2010 [source] The loneliness of the university museum curatorMUSEUM INTERNATIONAL, Issue 2 2000Jane Weeks Doubly isolated , from their colleagues within the university and from those in the larger museum community , university museum curators are learning to develop new approaches and missions for their institutions. Jane Weeks, a museum consultant specializing in museums in non-museum organizations, describes how this is being done in the United Kingdom. She has considerable experience of university museums, having managed a major Collections Management Project for University College London, and undertaken two regional surveys of university museums and collections in the south-west and the midlands of England, in conjunction with Kate Arnold-Forster. [source] Untersuchung verschiedener Bodenmodelle zur Berechnung von Fundamentplatten im Rahmen von FEM-LösungenBAUTECHNIK, Issue 5 2004Christian Barth Prof. Dr.-Ing. #Die wirklichkeitsnahe Abbildung von Bauwerk-Boden-Wechselwirkungen in Finite-Elemente-Programmen ist ungeachtet des gegenwärtig hohen Entwicklungsstands der verfügbaren Software eine nicht zu unterschätzende Aufgabe. Einerseits erfordert die richtige Einbindung des Bodenmodells in die FE-Berechnung viele Überlegungen und Kenntnisse, andererseits sind die in der Software implementierten Bodenmodelle aber für den Anwender nicht immer in ihrer gesamten Komplexität durchschaubar. Anhand alltäglicher Aufgabenstellungen werden vier verschiedene häufig verwendete und in FEM-Lösungen implementierte Bodenmodelle unterschiedlicher Softwarehersteller untersucht. Die erzielten Ergebnisse werden gegenübergestellt, und der Versuch einer Bewertung wird vorgenommen. Investigation of different models for the analysis of foundation slabs with reference to FEM solutions. The realistic interaction between a foundation slab and the soil in FE-programs is a formidable and complex task, despite the availability of sophisticated software solutions. On the one hand the incorporation of the slab-soil behaviour into conventional software programs requires considerable experience and thought and, on the other hand, existing software programs are often difficult to understand because of their complexity. Using common design examples four different models, which arc frequently used in FE solutions, are applied in this study. The results are compared and critically examined. [source] Outcome after radical prostatectomy with a pretreatment prostate biopsy Gleason score of ,8BJU INTERNATIONAL, Issue 6 2003M. Manoharan The use of radical prostatectomy to treat patients with high-grade prostate cancer is the subject of much discussion, and the authors from Miami present their considerable experience in this field. They show that patients with a pre-treatment biopsy of Gleason score of ,8 may benefit from radical prostatectomy, assuming a clinical stage of T1,T2, and particularly if their PSA level is <20 ng/mL. Authors from Palermo present data on the long-term outcome of antiandrogen monotherapy in advanced prostate cancer, with the 12-year results of a phase II study. This is a very interesting evaluation, showing that patients with an early objective response have a prolonged progression-free and overall survival. In a large series of superficial bladder tumours, urologists from Tokyo identify a group of patients with tumours of low malignant potential with a high recurrence rate, but a very low invasive property. They suggest that those tumours should be referred to as having a low malignant potential, rather than being called superficial bladder carcinoma. OBJECTIVE To determine the outcome and predictors of recurrence in patients with a pretreatment prostate biopsy Gleason score (GS) of ,,8 and treated with radical prostatectomy (RP). PATIENTS AND METHODS We retrospectively reviewed 1048 consecutive patients who underwent RP by one surgeon (M.S.S.); patients who had a pretreatment biopsy GS of ,,8 were identified. Information was recorded on patient age, initial prostate specific antigen (PSA) level, clinical stage, biopsy GS, pathology GS, extraprostatic extension (EPE), tumour volume, surgical margin status, seminal vesicle invasion (SVI), and lymph node involvement. The results were assessed statistically using the Kaplan-Meier method, univariate log-rank tests and multivariate analysis using Cox's proportional hazards regression. RESULTS In all, 123 patients met the initial selection criteria; 44 were excluded from further analyses (five salvage RP, 23 <,1 year follow-up and 16 adjuvant treatment). Thus 79 patients were included in the uni- and multivariate analyses; 25 (31%) patients had a GS of ,,7 in the RP specimen and 54 (69%) remained at GS ,,8. The mean follow-up was 55 months, the age of the patients 63 years and the mean (sd) initial PSA level 13 (12) ng/mL. The overall biochemical failure rate was 38% (41% if the final GS was , 8 and 32% if it was ,,7). For those with a GS of ,,8 in the RP specimen, 20% (11/54) were organ-confined; two patients (2.5%) in this group developed local recurrence. If the final GS was ,,7, 52% (13/25) were organ-confined. In the univariate analysis, significant risk factors for recurrence were PSA ,,20 ng/mL, EPE, SVI, a positive surgical margin and tumour volume. Cox's proportional regression indicated that a PSA of ,,20 ng/mL (hazard ratio 7.9, 95% confidence interval 2.6,24.2, P < 0.001), the presence of EPE (4.2, 1.6,10.9, P = 0.004) and a positive surgical margin (3.8, 1.5,9.7, P = 0.005) were significant independent predictors in a multivariate analysis. CONCLUSION RP is a reasonable treatment option for patients with a prostate biopsy GS of ,8 and clinical stage T1,2. These patients have a high chance of remaining disease-free if their PSA level is ,,20 ng/mL. Patients with a pretreatment biopsy GS of ,,8 should be counselled about the potential differences between the biopsy and the RP specimen GS. [source] | ||||||||||