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  • 1
    Electronic Resource
    Electronic Resource
    Factors associated with obtaining nipple aspirate fluid: Analysis of 1428 women and literature review (1990)
    Springer
    Breast cancer research and treatment 15 (1990), S. 39-51 
    Details
    ISSN: 1573-7217
    Keywords: age ; breast fluid ; breast diseases ; breast feeding ; breast secretion ; multivariate analysis ; race ; reproductive history ; selection bias
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Studies of cytologic and biochemical constituents of nipple aspirates of breast fluid have contributed to understanding the natural history of benign and malignant breast disease. We conducted multivariate analyses using 1428 women from a recent case-control study of breast disease to determine which factors were independently associated with the ability to obtain breast fluid from nonlactating women. We then compared results from these analyses to the results from five previous studies that also used the aspiration technique of Sartorius. Four factors were consistently associated across studies with increased ability to obtain breast fluid: 1) age up to 35 to 50 years; 2) earlier age at menarche; 3) non-Asian compared to Asian ethnicity; and 4) history of lactation. Exogenous estrogen use, endogenous estrogen concentrations, phase of menstrual cycle, family history of breast cancer, type of menopause, and less than full-term pregnancy consistently did not influence ability to obtain fluid. New findings from this study shed light on some apparently contradictory findings from the previous studies. In particular, this study showed that the effects of age on ability to obtain fluid appeared to be independent of the effects of menopause. Furthermore, discrepancies in previous findings on the effects of parity on ability to obtain fluid may be explained by our finding that the increased ability to obtain fluid from parous compared to nulliparous women applied only to parous women who had breastfed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01811888
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Consideration of individual bioequivalence (1990)
    Springer
    Journal of pharmacokinetics and pharmacodynamics 18 (1990), S. 259-273 
    Details
    ISSN: 1573-8744
    Keywords: bioequivalence ; binomial tests ; 75/75 rule
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Current procedures for assessing the bioequivatence of two formulations are based on the concept of average bioequivalence. That is, they assess whether the average responses between individuals on the two formulations are similar. Average bioequivalence, however, is not sufficient to guarantee that an individual patient could be expected to respond similarly to the two formulations. To have reasonable assurance that an individual patient could be switched from a therapeutically successful formulation to a different formulation (e.g., a generic substitute) requires a different notion of bioequivalence, which we refer to as individual (or within-subject) bioequivalence. We propose a simple, valid statistical procedure for assessing individual bioequivalence. The decision rule, TIER (Test of Individual Equivalence Ratios), requires the specification of the minimum proportion of subjects in the applicable population for which the two formulations being tested must be bioequivalent (a regulatory decision). The TIER rule is summarized in terms of the minimum number of subjects with bioavailability ratios falling within the specified equivalence interval necessary to be able to claim bioequivalence for given sample size and Type I (α) error. We recommend that the corresponding lower bounds (one-sided confidence intervals) for the proportion of bioequivalent subjects be calculated. TIER is partly motivated by the U.S. FDA's 75/75 Rule (at least 75% of the individual subject bioavailability ratios must be within 75–125%). TIER retains the sensible idea of considering the individual ratios but, unlike the 75/75 rule, is a statistically valid procedure.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01062202
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    Paper (German National Licenses)
    Fulltext
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