ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

The aims of this study were to investigate possible interactions between EchoGen, a transpulmonary contrast agent in development that vaporizes after injection, and sevoflurane, and to determine the safety of the co-administration of sevoflurane and EchoGen. A phase I, double-blind, randomized, placebo-controlled, three-way crossover study was done in 12 healthy male volunteers receiving: EchoGen alone, sevoflurane+EchoGen or sevoflurane+saline placebo. Safety was assessed using physiological and haematological monitoring and by documenting adverse events. The mean degree of echocardiography image enhancement was significantly higher for EchoGen alone (78.2) than when combined with sevoflurane (61.2)P=0.036. Both were significantly better than saline placebo (P<0.0001). The mean minimum alveolar concentration of sevoflurane was 2.5% with EchoGen and 2.3% with saline (NS). There were no marked differences in the distribution of reported adverse events between the sevoflurane/EchoGen and sevoflurane/saline treatments. Results of other safety analyses, including vital signs, laboratory evaluations and physical examinations, were unremarkable. It is concluded that EchoGen with or without administration of sevoflurane significantly enhances echocardiographic image quality compared with saline placebo. However, image quality is significantly better with EchoGen in the absence of sevoflurane. EchoGen does not interfere with the anaesthetic action of sevoflurane. No new safety concerns were identified for either EchoGen or sevoflurane, alone or in combination.

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

This article provides a comprehensive guide for the use of electrocardiographic (ECG) assessments in clinical trials, for non anti-arrhythmic products, drawing together scientific information and current and proposed regulatory requirements and guidelines. Standard definitions of normal values of ECG intervals, ECG diagnostic criteria for myocardial infarction and left ventricular hypertrophy, and the frequency of expected ECG abnormalities are presented. A focus on the problem of drugs that affect the QTc interval including the regulatory concern and associated factors are reviewed. The high spontaneous variability in QTc duration requires careful attention to the planning and interpretation of ECG data if a true QTc effect of a new drug is to be detected adequately. Too much additional extrinsic variability may compromise the ability to detect a signal amongst the noise. The sources of extrinsic variability that must be considered in clinical research include: ECG acquisition methods; adequacy of ECG collection, especially at baseline and at steady state or peak drug concentration; sample size; presence of control groups; ECG measurement accuracy; and proper use of formulae for correcting QT to QTc. There are several compelling reasons to utilize centralized ECG analysis as the primary method of collation and analysis of 12-lead ECGs in clinical studies. While ECG effects are initially well defined in phase I studies, confirmation in phases II and III is still required since safety in the target population with co-morbidities and concomitant medications must be confirmed. All ECGs should be statistically analysed and reported according to pre-defined standards. These should be developed according to the specific project requirements, the known or suspected properties of the test compound and the intended treatment regimen. A standard analysis plan is proposed.

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

The vagina is a potential site for the local and systemic delivery of drugs. Presently, significant attention is given to the development of vaginal formulations (‘microbicides') that prevent sexual acquisition of acquired immunodeficiency syndrome (AIDS) and other sexually transmitted diseases. Acceptability of vaginal dosage forms may vary among women from different geographical and socioeconomic backgrounds. Therefore, in the drug development process, selection of an appropriate dosage form is crucial for consumer acceptance and use. The primary objective of this study was to survey vaginal preparations available in the Indian market to determine the types of products that are most frequently used by Indian women. In addition, this survey provides information about the active ingredients and dosage forms of these products. The physicochemical properties of selected products were compared in order to help formulation scientists to design vaginal formulations with desired properties. Indian vaginal products are available in several different dosage forms. Tablets are marketed most frequently (38%), followed by gels (15%) and creams (15%). The evaluated products varied greatly in their physicochemical properties such as colour, pH, disintegration, viscosity, osmotic pressure and bioadhesive properties. The information can serve as reference on vaginal products in the Indian market and to aid in the development of new vaginal formulations, especially for India and other tropical countries.

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS