ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

摘要:

The regulatory affairs stereotypes presented by the author are meant to highlight some basic faults and foibles that distinguish the mere practitioner of the regulatory affairs discipline from the true regulatory affairs professional. General regulatory affairs style stereotypes are presented, followed by some international examples. These international stereotypes are meant to highlight ways that national cultures and attitudes may interfere with the free exchange of regulatory affairs information and cooperation between regulatory professionals from different countries. The description of each stereotype is followed by suggestions of ways to improve your effectiveness and professionalism.The author intends no insult to any individual or nationality, but instead, sincerely wishes that these examples will challenge the readers to survey their regulatory style, and work to improve their professionalism, within their own home country and internationally. The author further hopes that this article will trigger discussion and prompt additional positive suggestions from others on how each of us might become more professional and effective in the international aspects of our jobs.@SUMMARY TEXT =

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

摘要:

Pharmacovigilance is facing expanding challenges from both the pharmaceutical business and the regulatory agencies, which impact all global pharmaceutical organisations. In the consumer healthcare setting, world-wide sales, regulatory expectations and public awareness of product issues are all increasing. The challenge of maintaining both high-quality adverse event reporting and regulatory compliance in the face of capacity constraints and the evolving safety environment is real. In this context, the pharmacovigilance organisation of GlaxoSmithKline (GSK) Consumer Healthcare redesigned their global processes to world-class standards and implemented industry best practices in order to achieve substantial growth in productivity while maintaining regulatory and corporate compliance. In a year-long initiative, GSK Consumer Healthcare Product Safety has achieved a 70% reduction in adverse event handling process complexity and a 30% increase in productivity; global organisational and process consistency have also significantly improved. GSK Consumer Healthcare Product Safety has also implemented a managerial decision-making system that generates a wide range of rigorous key performance measures. This system allows management to stay continually informed of the global safety operation and initiate proactive, specific improvements or corrective actions based on reliable and up-to-date data. With all these initiatives, GSK Consumer Healthcare Product Safety has placed itself among the best organisations in the industry and on the clear path of continuous improvement.

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

摘要:

The increasing demand to improve the quality of clinical research has been addressed in recent years in Germany. In a response designed to overcome the shortcomings of existing collaboration between academic institutions, contract research organisations (CROs), and the pharmaceutical industry, clinical study centres have been initiated and funded by the German Ministry for Science and Technology. In addition, CROs and the pharmaceutical industry have independently found ways to establish collaborative networks via close links to university medical departments. This article provides two examples demonstrating how this has been accomplished in Berlin, Germany. Firstly, a CRO, 3ClinicalResearch, having in place a formal cooperation agreement with the university hospital, together with a physical representation at its heart, via a research unit on the central campus of the Charité Hospital in Berlin, Germany. Secondly, a drug discovery and development company, Jerini AG, specialising in peptidomimetic and small molecule development.

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

摘要:

ObjectivesStudies of novel immunosuppressive agents using small numbers of healthy volunteers require validated methods for detecting pharmacodynamic effects. We investigated the ability of tuberculin-stimulated lymphocyte proliferation in whole blood and the tuberculin skin test to assess immunosuppression in healthy volunteers.MethodsThis was a parallel-group, placebo-controlled study. Five weeks after a tuberculin test, 14 study participants received either placebo or prednisolone (30mg or 60mg) once daily for 7 days. Blood samples were collected before the first dose and at 2 hours post-first dose for assessment of lymphocyte proliferation. On day 5, a repeat skin test was administered.ResultsLymphocyte proliferation was reduced in all ten study participants who received prednisolone (mean reduction: 30mg = 77.5%, 60mg = 77%; p < 0.01 compared with placebo) with no reduction in any of the placebo group. While prednisolone reduced skin test size in seven study participants, there was an increase in three participants and no overall significant effect compared with placebo (p > 0.05).ConclusionLymphocyte proliferation in whole blood was able to detect pharmacological immunosuppression in healthy individuals, while the tuberculin skin test did not. This whole blood method may have applications for detecting the effects of novel compounds in future healthy volunteer studies.

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

摘要:

Bile beans was a very popular proprietary medicine during the twentieth century in the UK. The product consisted of a variety of purgatives, cholagogues and carminatives formulated into a pill and advertised for ‘inner health’. The product was devised in Australia in 1899, survived a damning judgement in a law court in Scotland in 1905, became a brand leader in the 1930s and was on sale until the mid-1980s.

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2003

数据来源: ADIS