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:

This investigation was conducted to study the effect of food on the oral absorption and disposition of glyburide (glibenclamide). The study was carried out under US Food and Drug Administration guidelines on 18 healthy male volunteers, under fasting and feeding conditions using a single oral dose (5 mg tablet) of glyburide. Following drug administration, blood samples were collected over 24 h, and serum harvested from the blood was analysed using a sensitive and specific high‐ performance liquid chromatographic assay. The results of this investigation indicated that there was a statistically significant difference in the concentration–time profiles of the drug and the obtained pharmacokinetic parameters under fasting and feeding conditions. In fasting conditions, area under the serum concentration–time curve for 24 h and peak serum concentration were significantly higher than feeding conditions. Lag time between administration and appearance of the drug in serum was significantly reduced in fasting conditions compared with feeding situations. There was no significant difference in the time needed to reach peak concentration. These findings clearly indicate that the extent and rate of glyburide absorption is delayed when administered under feeding conditions. The study demonstrates the importance of administration of the drug on empty stomach to achieve a better pharmacokinetic profile.

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

摘要:

On 26 February 2001 the Council of the European Union formally adopted a Directive relating to the conduct of clinical trials. On 1 May 2001 the Directive came into force. This new Directive is the first one aimed solely at clinical trials. The rules and regulations governing clinical trials can currently be found in a variety of European and domestic legislation. The new clinical trials Directive seeks to ‘simplify’ and ‘harmonize’ such trials by establishing a ‘clear, transparent procedure’ and by ‘creating conditions conducive to effective co‐ordination of such clinical trials’ by the relevant authorities of each European Member State.

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

摘要:

This article compares and contrasts the regulation of medicinal products and medical devices in the UK and in Europe. While there are many similarities in the control between the two sectors there are marked differences. These differences arise partly from the different nature of the products and the industries, but also from the different type of control. Medical devices are controlled through the ‘New Approach’ Directives. Both regulatory systems are currently undergoing European Reviews. The borderline between medicinal products and devices is considered in this article noting that in many areas the distinction is becoming increasingly complex.

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