ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

摘要:

The conduct of clinical trials in Asia is a rapidly evolving process. Herein, we attempt to outline the current status of good clinical practice (GCP) standards and regulatory requirements in the region (excluding China and Japan). These vary significantly making some countries more attractive than others for the conduct of global studies. Government bodies and the pharmaceutical industry can both contribute to the continued improvements in standards of trial conduct. There are significant clinical opportunities for studying diseases more prevalent in this region than elsewhere. Furthermore, major benefits can accrue from conducting studies in the region, to companies, to investigators, to physicians and most importantly to patients in the local population.

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

摘要:

Respiratory syncytial virus (RSV) and human parainfluenza virus type 3 (HPIV‐3) are the major causes of lower respiratory tract infection in infants and young children. RSV is also responsible for a significant amount of morbidity and mortality in the elderly, the immunosuppressed and those with chronic cardiac or pulmonary disease. Despite extensive research, no effective antiviral therapy or vaccine is currently available for either virus. Over the past 20 years a number of different approaches for developing vaccines for RSV and HPIV‐3 have been tested, with varying degrees of success. However, as it is not yet possible to identify one strategy that yields a vaccine preparation suitable for all high‐risk populations, a multi‐faceted approach to RSV and HPIV‐3 vaccine development is still necessary. Ribavirin and immunoglobulin preparations with high titres of RSV‐specific neutralizing antibodies are licensed for the treatment and prevention of RSV infection, but neither is cost‐effective or easy to administer. New clinically effective agents are needed to diminish the impact of RSV and HPIV‐3. This article will review the currently available means for controlling the two viruses, the search for new antiviral agents, and future prospects for preventing and treating RSV and HPIV‐3 infections.

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

摘要:

The members of the Bundesverband Medizinischer Auftragsinstitute (BVMA) or Federal Association of Contract Research Organizations (CROs) are scientific enterprises offering services in clinical trials of drugs. In order to guarantee high quality services, all members of the BVMA underwent an independent external system audit according to a single predefined standard. The selection of one of several proposed audit organizations was based on personal presentation and two sample audits. The audit organization finally commissioned planned the system audit in co‐operation with the BVMA and prepared a special audit standard operating procedure (SOP). The facilities, equipment, and personnel qualifications as well as compliance of procedures with GCP standards and the companies' SOPs were inspected in 17 member CROs. The overall result of the system audit was positive with no serious findings indicating impairment of the quality of services offered. The remaining findings were classified in 31 cases as ‘major’ (significant deviation from GCP and SOPs without impairing quality of services) and in 163 as ‘minor’ (insignificant deviation). The audit findings were described for each CRO in an audit report that required a response from the audited CRO within 28 days. If major findings were not remedied within 9 months, a follow‐up audit was to be conducted. The feedback of the audited members was mainly positive. This system audit has documented the high quality of the BVMA members. Regular audits are planned in the future and will be prepared by a newly‐established BVMA ‘quality assurance’ working group.

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS