Culture and Change in Developing Western Countries

Montgomery, Anthony

doi:10.1002/9781118326404.ch18

Cited by 2 publications

(1 citation statement)

References 71 publications

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“…Baseline and weekly assessments included markers of transplant function in individuals with a kidney transplant (creatinine) or liver transplant (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase). To compare kidney and liver function tests among products, a mixed effects model was run with a term designating the product received in each period and a random subject term and using the Tukey’s honest significant difference (HSD) test for multiple comparisons, where needed [ 35 ]. The study was not powered to assess differences in transplant organ function.…”

Section: Methodsmentioning

confidence: 99%

Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial

et al. 2017

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BackgroundAlthough the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, “brand”) product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant.Methods and findingsFrom December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35) or liver transplant (n = 36). Abbreviated New Drug Applications (ANDA) data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug Administration (FDA) average bioequivalence (ABE) acceptance criteria of a 90% confidence interval contained within the confidence limits of 80.00% and 125.00%. Within-subject variability was similar for the area under the curve (AUC) (range 12.11–15.81) and the concentration maximum (Cmax) (range 17.96–24.72) for all products. The within-subject variability was utilized to calculate the scaled average bioequivalence (SCABE) 90% confidence interval. The calculated SCABE 90% confidence interval was 84.65%–118.13% and 80.00%–125.00% for AUC and Cmax, respectively. The more stringent SCABE acceptance criteria were met for all product comparisons for AUC and Cmax in both individuals with a kidney transplant and those with a liver transplant. European Medicines Agency (EMA) acceptance criteria for narrow therapeutic index drugs were also met, with the only exception being in the case of Brand versus Generic Lo, in which the upper limits of the 90% confidence intervals were 111.30% (kidney) and 112.12% (liver). These were only slightly above the ...

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Section: Methodsmentioning

confidence: 99%

Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial

et al. 2017

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The influence of a market-oriented primary care reform on family physicians’ working conditions: A qualitative study in Turkey

Çiçeklioğlu

Öcek

Türk

et al. 2014

European Journal of General Practice

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Background: Turkey has undergone a 'Health transformation programme' putting emphasis on the reorganization of primary care (PC) services towards a more market-oriented system. Objectives: To obtain a deep understanding of how family physicians (FPs) experienced the process of the reforms by focusing on working conditions. Methods: This phenomenological and qualitative research used maximum variation sampling and 51 FPs were interviewed in 36 in-depth and four focus-group interviews. Results: Thematic analysis of interviews provided seven themes: (1) change in the professional identity of PC physicians (physician as businessperson); (2) transformation of the physician-patient relationship in PC (into a provider-customer relationship); (3) job description and workload; (4) interpersonal relationships; (5) remuneration of FPs, (6) uncertainty about the future and (7) exhaustion. Most FPs felt that the Family medicine model (FMM) placed more emphasis on the business function of family practice and this conflicted with their professional characteristics as physicians. FPs complained that some of their patients behaved as extremely demanding consumers. Continuously increasing responsibilities and extremely high workload were commonly reported problems. Most participants described the negative incentives in the performance scheme as a degrading method of punishment. The main factor was job insecurity caused by contract-based employment. FPs described the point at which they are with terms such as exhaustion. Conclusion:By increasing workload and creating uncertainty about the future and about income, the PC reforms have led to working conditions, which has led to changes in the professional attitudes of physicians and their practice of medicine.

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Culture and Change in Developing Western Countries

Abstract: … a talent for speaking differently rather than for arguing well, is the chief instrument of cultural change. Rorty (1989, p. 7)

Cited by 2 publications

References 71 publications

Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial

Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial

The influence of a market-oriented primary care reform on family physicians’ working conditions: A qualitative study in Turkey

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