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  • 1
    Electronic Resource
    Electronic Resource
    Springer
    Pharmaceutical research 17 (2000), S. 375-380 
    ISSN: 1573-904X
    Keywords: individual bioequivalence ; within-subject variability ; subject-by-formulation interaction ; subgroups
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Purpose. The FDA has proposed replacing the current averagebioequivalence criterion with population and individual bioequivalence criteriathat consider variances in addition to the difference of averages. Oneof these variances in the individual bioequivalence criterion measuressubject-by-formulation interaction, the extent to which thetest-reference difference varies from person to person. This paper discussesconceptual and statistical issues raised in various publications andpresentations with respect to the presence and estimation of such aninteraction. Methods. We focus on the importance of subject-by-formulationinteraction, an understanding of what is a large interaction, and theassessment of the magnitude of this interaction in bioequivalence studies.Simulation studies, examples from the literature, and data from FDAfiles are used to demonstrate the magnitude of the interaction and itsdistribution under various conditions. Results. The concept of a large interaction is tied to the concept of alarge mean difference. We suggest that an interaction greater than0.15 is a conservative criterion for a large interaction. Magnitudes ofestimated interaction are affected by variability, sample size, and theselection of data sets that pass average bioequivalence. Conclusions. Examples of substantial interactions are beginning toappear. More data is needed before reaching definitive conclusionsregarding the frequency and importance of observed interactions.
    Type of Medium: Electronic Resource
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  • 2
    Electronic Resource
    Electronic Resource
    Oxford, UK : Blackwell Publishing Ltd
    The @breast journal 4 (1998), S. 0 
    ISSN: 1524-4741
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Abstract: Due to the increased efforts of early detection and biopsy of breast lesions, the number of cases with hyperplastic and in situ lesions seen in most pathology laboratories has increased significantly. Pathologists are faced with a greater number of biopsies and a wider spectrum of lobular and ductal lesions including papillary lesions. A set of 31 randomly selected glass slides of ductal, lobular and papillary lesions (benign, borderline, and carcinomas in situ) was circulated among five community- and five academic-based pathologists (median 9 years of experience). The pathologists filled out a standard form for each case which included lesion type (ductal, lobular, or papillary) and diagnostic category (ductal, lobular, or papillary; hyperplasia or carcinoma). We compare the participants' diagnoses, their histologic criteria, and the reproducibility of the diagnoses. Kappa statistics were calculated to measure the levels of agreement among community and academic pathologists, overall for all the pathologists, and within a subgroup of eight participants reporting the use of the same diagnostic criteria (Page's). All pathologists agreed with the diagnosis of cancer in 10 cases (33%), kappa overall 0.347 (fair); with the diagnostic category of lesions in 8 cases (27%), kappa overall 0.537 (moderate); and with the lesion type in 16 cases (53%), kappa overall 0.789 (substantial). Community pathologists were more likely to interpret ductal and papillary lesions as hyperplasias than carcinomas in situ. In contrast, academic pathologists interpreted more cases as carcinomas than hyperplasias (60 versus 45). There was little to no improvement in the level of agreement observed when we considered the subgroup of pathologists using the same standardized criteria. This study demonstrates that the overall agreement in the diagnosis of carcinoma in situ of the breast remains low between pathologists using or not using standardized diagnostic criteria. Papillary and ductal lesions pose a significant problem between observers in characterizing them as benign or malignant. Current diagnostic criteria need to be modified, reemphasized, or replaced, either through the literature or with additional training to decrease interobserver variability.
    Type of Medium: Electronic Resource
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  • 3
    Electronic Resource
    Electronic Resource
    Boston, MA, USA : Blackwell Science Inc
    The @breast journal 5 (1999), S. 0 
    ISSN: 1524-4741
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Type of Medium: Electronic Resource
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