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

摘要:

The objective of the study was to determine practical issues associated with rapid intravenous infusion delivery of volumes up to 100 ml. The study was of an open, randomized, three-way crossover design, and was conducted in 20 healthy volunteers. Each subject was to receive manually delivered infusions of 30, 60 and 100 ml of 0.9% saline solution, with a minimum interval of 30 min between infusions. The infusate was delivered manually using a variety of syringe sizes, and with a target delivery time of 1 min. Resistance determined the rate of manual delivery.As the volume to be infused increased, the time taken to complete the manual injection also increased. The mean times for infusing 30, 60, and 100 ml were 11.5, 34.6 and 45.4 s, respectively. At the highest infusion volume, approximately 90% of all subjects were infused in less than 1 min. The number of syringes used had a greater impact on the duration of infusion than the total volume infused. Infusions were well tolerated.A volume of 100 ml is considered to be the limit for a rapid intravenous infusion to be delivered over approximately 1 min. As such, this will determine the concentration of drug in solvent when drugs are being developed for administration by rapid intravenous injection.

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS

摘要:

Photochemical decomposition of two derivatives of 1,4-dihydropyridine (DHP): felodipine (FL) and nimodipine (NM) was studied. Photodegradation of FL and NM was carried out in compliance with the first version of International Conference on Harmonization (ICH) recommendations. Quantitative assessment of photodegradation of the DHP derivatives studied was performed on the basis of decomposition rate constants (k), time of decomposition of half of the compound (t0.5) and time of decomposition of 10% of the compound (t0.1). The two analytical methods applied: ultraviolet spectrophotometry and HPLC, permitted determination of the kinetic parameters of NM and FL photodegradation described as a dependence ln c=f(t). Quantitative assessment of the photodegradation of DHP derivatives was also made on the basis of determination of quantum yields of the photochemical reactions which was performed using Reinecke salt as chemical actinometer. To get the real quantum yield the apparent quantum yields were extrapolated to zero exposition time. For the compounds studied the quantum yields were in the range 10−3–10−5, which indicates occurrence of secondary photochemical reactions. The photochemical stability of FL was found to be greater than that of NM.

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 Italian Ministry of Health on 18 March 1998 issued a decree, drastically modifying the process to activate clinical studies. In fact, Institutional Ethics Committees were given the tasks of both approving clinical protocols and the relevant IND documentation.The new procedure appeared to reduce the approval times of the process: after 3 years from its implementation, the SSFA (Scientific Association of Researchers in the Pharmaceutical Industry) promoted a survey to measure these apparent benefits achieved and to identify pending issues.The survey, which had a 50% response rate, confirmed the positive impact of the new regulation, with average approval times moving from 73.4 days in 1998 to 41.5 days in 2000. This significant shortening in timelines had a positive impact on both the number of studies activated in Italian centres and the number of patients entered into clinical trials. The survey allowed us to identify some pending issues, which are now closely monitored and discussed in a working party with representatives of Ethics Committees and medical departments.

ISSN:1364-9027    

出版商:ADIS    

年代:2001

数据来源: ADIS