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  • 1
    Electronic Resource
    Electronic Resource
    BIOEQUIVALENCE STUDIES OF TOPICAL PREPARATIONS: STATISTICAL CONSIDERATIONS (1992)
    Oxford, UK : Blackwell Publishing Ltd
    International journal of dermatology 31 (1992), S. 0 
    Details
    ISSN: 1365-4632
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: To be approved for marketing, a potential generic pharmaceutical product must demonstrate bioequivalence, that is, a rate and extent of absorption similar to those of the currently marketed (“innovator”) product. For oral products, design and statistical analysis for studies conducted to determine whether two products are bioequivalent have become reasonably standardized; the design is crossover, and analysis is based on the two one-sided tests principle. The purpose of this overview is to consider whether the practices for oral products apply to topical products, and where different procedures may be required. The principles behind the practices for oral products are seen, largely, to carry over to topical products.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1365-4362.1992.tb04010.x
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  • 2
    Electronic Resource
    Electronic Resource
    Reduction of Langerhans cells in smokeless tobacco-associated oral mucosal lesions (1992)
    Oxford, UK : Blackwell Publishing Ltd
    Journal of oral pathology & medicine 21 (1992), S. 0 
    Details
    ISSN: 1600-0714
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Localized absence of epithelial Langerhans cells (LC) has been shown to affect systemic immune responses, allow microbial colonization and play a possible role in carcinogenesis. Because use of smokeless tobacco is associated with abnormal oral mucosal changes and development of carcinoma, we examined lesion and control specimens from 17 current users of smokeless tobacco to determine whether lesions showed changes in LC number or antigen expression. We identified LC by immunohistochemistry with antibodies to the antigens T6, HLA-DR, HLA-DQ, and HLA-DP. Lesion specimens contained fewer LC (means of 6 LC/mm and 10 LC/mm2) than did the corresponding control specimens (means of 14 LC/mm and 30 LC/mm2), and in each pair of lesion and autologous control specimens the reduction in LC was on average 58% (range, 3% to 95%). There were no apparent differences between lesion and control specimens in the number of LC expressing each of the four marker antigens. Reductions in LC occurred in all types of smokeless tobacco-associated lesions, regardless of increased epithelial thickness or changes in keratinization. Our data indicate that smokeless tobacco reduces the number of Langerhans cells at its site of contact with the oral mucosa.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1600-0714.1992.tb00990.x
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  • 3
    Electronic Resource
    Electronic Resource
    Measuring switchability and prescribability: When is average bioequivalence sufficient? (1994)
    Springer
    Journal of pharmacokinetics and pharmacodynamics 22 (1994), S. 551-564 
    Details
    ISSN: 1573-8744
    Keywords: individual bioequivalence ; population bioequivalence ; prescribability ; switchability
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Recent work, beginning with that of Anderson and Hauck in 1990, has led to a general acceptance of the need to ensure switchability in bioequivalence testing for approval of generic drugs. In other applications of bioequivalence testing, prescribability may be sufficient. However, there is less acceptance of the need to change statistical procedures and study designs from those currently used to assess the current criterion of average bioequivalence. We propose easily interpreted measures of switchability and prescribability. These measures provide bases for assessing conditions under which average bioequivalence is not sufficient to ensure switchability and prescribability, and hence for which a procedure for individual or population bioequivalence is required. The required conditions are sufficiently tight that they cannot be presumed to hold. Thus, there are reasonable conditions for which current practice is not sufficient. An outcome of this development is a connection between two current approaches for assessing individual bioequivalence.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02353794
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  • 4
    Electronic Resource
    Electronic Resource
    Considerations in the Attainment of Steady State: Aggregate vs. Individual Assessment (1998)
    Springer
    Pharmaceutical research 15 (1998), S. 1796-1798 
    Details
    ISSN: 1573-904X
    Keywords: multiple-dose clinical pharmacology trials ; steady state pharmacokinetics ; aggregate evaluation ; individual evaluation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1011933401522
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  • 5
    Electronic Resource
    Electronic Resource
    Cmax/AUC, A Commentary (1997)
    Springer
    Pharmaceutical research 14 (1997), S. 967-968 
    Details
    ISSN: 1573-904X
    Keywords: secondary metrics ; Cmax ; Cmax/AUC ; bioequivalence
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1012128623213
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  • 6
    Electronic Resource
    Electronic Resource
    Clinic characteristics associated with reduced hospitalization of druc users with aids (1998)
    Springer
    Journal of urban health 75 (1998), S. 153-169 
    Details
    ISSN: 1468-2869
    Keywords: Acquired immunodeficienty syndrome ; Substance abuse ; Hospitalization ; Ambulatory care
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objective To identify features of ambulatory care associated with reduced hospitalization among drug users with acquired immunodeficiency syndrome (AIDS). Methods A nonconcurrent prospective study of hospital use by 1,369 drug users with AIDS was conducted using data from New York State Medicaid research data files linked to telephone interview data from directors of ambulatory care clinics serving this group. Results Follow-up averaged 29 months, during which 88% of subjects were hospitalized at least once. On average, those hospitalized spent 14% of follow-up time as inpatients. Hospitalization was less likely for patients in clinics with case managers (adjusted odds ratio=0.42, 95% confidence interval 0.25, 0.68) or high director’s rating of coordination of care (adjusted odds ratio=0.50, 95% confidence interval 0.29, 0.89). Multivariate analysis showed significantly less time in hospital for patients in clinics with methadone maintenance, case managers, high continuity ratings, and clinic physicians attending for hospitalized clinic patients. Conclusions Drug users with AIDS rely heavily on inpatient care, but those followed in clinics featuring greater coordination and offering special services, including methadone treatment and case management, appear to have significantly less hospital use.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02344936
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  • 7
    Electronic Resource
    Electronic Resource
    Bioequivalence: Performance of Several Measures of Rate of Absorption (1994)
    Springer
    Pharmaceutical research 11 (1994), S. 966-974 
    Details
    ISSN: 1573-904X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The highest point of the plasma concentration-time profile, C max , is currently used by regulatory agencies to assess the rate of drug absorption after single dose administration of oral products. It is, however, quite insensitive, and a number of new measures of rate have been proposed. Using simulations, several approaches toward measuring rate were tested. A set of model scenarios for drugs with typical mean characteristics and statistical distributions was investigated. Using different kinetic models of disposition, the time course of the concentration in plasma was simulated. Intraindividual and interindividual variability and assay error were modeled using Monte Carlo techniques. The accuracy, precision, and ease of use of the various measures of rate were evaluated by simulating crossover design clinical trials and then determining the probability of declaring bioequivalence as a function of differences in rates of absorption between test and reference formulations. All of the rate measures tested showed a degree of insensitivity to changes in rate and no universally superior measure was found. Indeed, the main conclusion is that the choice of a measure should be based on simulations of the particular situation in a bioequivalence trials.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1018970901116
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  • 8
    Electronic Resource
    Electronic Resource
    Bioequivalence: Performance of Several Measures of Extent of Absorption (1994)
    Springer
    Pharmaceutical research 11 (1994), S. 715-722 
    Details
    ISSN: 1573-904X
    Keywords: pharmacokinetics ; bioequivalence ; extent of absorption ; power analysis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The determination of the area under the concentration–time curve (AUC) is the method most commonly used by regulatory agencies to assess extent of drug absorption after single-dose administration of oral products. Using simulations, several approaches toward measuring the actual area, in whole or part, were tested. In addition, the performance of the peak concentration (C max), usually taken as a measure of the rate of absorption was assessed evaluating extent. Model scenarios for drugs with typical mean characteristics and statistical distributions were investigated. Using different kinetic models of disposition, the time course of the drug concentration in plasma was simulated. Intraindividual and interindividual variability and assay error were modeled using Monte Carlo techniques. The accuracy, precision, and ease of use of the various measures of extent were evaluated, and statistical power analyses were performed. Among the measures tested, the most reliable were the AUC computed up to the time of the last quantifiable concentration, without extrapolation, and C max. However, being also sensitive to rate, C max as a measure of extent is of limited potential.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1018932430733
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  • 9
    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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  • 10
    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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