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The discontinuance of innovations in pharmaceutical labeling.

機譯:藥品標簽創(chuàng)新的中斷。

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This dissertation is about the discontinuance of innovations affecting the labeling for pharmaceutical products. Current FDA regulations in the Code of Federal Regulations (CFR) state that the "Labeling on or within the package from which the drug is dispensed bears adequate information for its use..." (21 CFR 201.100) Since it is physically attached to the product, full prescribing information is available to the pharmacist dispensing the drug.; In 1999, a proposal was submitted to the FDA by the Pharmaceutical Research Manufacturers of America, (PhRMA) a lobby representing the country's leading research-based pharmaceutical and biotechnology companies to replace the paper labeling with an electronic version of the full prescribing information. This document is labeled Appendix A. The innovations recommended by this proposal are intended to improve the timeliness of drug information delivered to dispensing sites.; Also, the innovations are intended to eliminate much of the material costs associated with the production, storage and distribution of drug labeling. If adopted, the PhRMA paperless labeling proposal may require a change to the federal regulation governing food and drug labeling. This dissertation researches the adoption response by the pharmaceutical dispensing community for this innovation suggested to improve pharmaceutical labeling.; Consistent with Rubin, (1995) qualitative interviewing was used in this dissertation due to the richness of knowledge gained from documentation, archival records, interviews, direct observations, participative observations, and physical artifacts within and governing the pharmaceutical labeling community. This research has also used a grounded theory approach as the basis for this research. According to Strauss and Corbin, (1994) this utilizes "the development or generation of a theory closely related to the context of the phenomenon being described." Pharmacists were examined using a questionnaire and others in the industry were examined through in-depth interviews. The findings from both approaches were congruent and support the null hypothesis that Rogers five and Moore Benbasat's two factors are predictors for the innovation's adoption.
機譯:本文是關(guān)于影響藥品標簽創(chuàng)新的中止?,F(xiàn)行的FDA聯(lián)邦法規(guī)(CFR)法規(guī)規(guī)定,“在分發(fā)藥物的包裝上或包裝內(nèi)的標簽帶有充分的使用信息...”(21 CFR 201.100),因為它物理上附著在包裝上。產(chǎn)品,配藥的藥劑師可獲得完整的處方信息。 1999年,美國藥物研究制造商(PhRMA)向大廳提交了一份提案,該代表代表該國領(lǐng)先的研究性制藥和生物技術(shù)公司的游說機構(gòu)用紙質(zhì)標簽替換了全部處方信息的電子標簽。該文件被標記為附錄A。本提案建議的創(chuàng)新旨在提高配送到配藥地點的藥品信息的及時性。同樣,這些創(chuàng)新旨在消除與藥品標簽的生產(chǎn),存儲和分配相關(guān)的許多材料成本。如果通過,PhRMA無紙化標簽提案可能需要更改有關(guān)食品和藥品標簽的聯(lián)邦法規(guī)。本文研究了藥物配藥界對采用這種創(chuàng)新建議以改善藥物標記的反應(yīng)。與魯賓(1995)一致,本論文采用定性訪談,因為從文獻,檔案記錄,訪談,直接觀察,參與性觀察以及在藥品標簽界內(nèi)部和管理中的物理制品中獲得了豐富的知識。本研究還使用了扎根的理論方法作為本研究的基礎(chǔ)。根據(jù)Strauss和Corbin(1994)的研究,“利用了與所描述現(xiàn)象的背景密切相關(guān)的理論的發(fā)展或產(chǎn)生”。使用調(diào)查表對藥劑師進行了檢查,并且通過深度訪談對行業(yè)中的其他人員進行了檢查。兩種方法的發(fā)現(xiàn)是一致的,并支持零假設(shè),即羅杰斯五世和摩爾本巴薩特的兩個因素是創(chuàng)新采用的預(yù)測因素。

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