Medicine response tests

One additional strategic issue must be recognized in drug development. Submission of data to support the use of a medicine response test must be coordinated with the submission of the application for marketing of the medicine. In the U.S., both centers are under the umbrella of the FDA, but this is not necessarily true in all countries. The timing of these submissions is critical to ensure that the test will be available at the time of the approval of the drug. Furthermore, as mentioned above, for maximum efficiency in the approval of subsequent test improvements, DNA samples of patients whose data support the claims for the medicine response test need to be maintained according to GLP. 

There will be a number of people who will be concerned about whether patients and health care providers are ready for medicine response tests and... 

A new HP-TLC method has been applied for the quantitative analysis of flavonoids in Passiflora coerulea L. The objective of the experiments was the separation and identification of the compound(s) responsible for the anxiolytic effect of the plant. Samples were extracted with 60 per cent ethanol or refluxed three times with aqueous methanol, and the supernatants were employed for HPTLC analysis. Separation was performed on a silica layer prewashed with methanol and pretreated with 0.1 M K2HP04, the optimal mobile phase composition being ethyl acetate-formic acid-water (9 1 l,v/v). It was established that the best extraction efficacy can be achieved with 60 - 80 per cent aqueous methanol. The HPTLC technique separates 10 different flavonoids, which can be used for the authenticity test of this medicinal plant [121],... 

In contrast to the documented effect of cotton dust on acute responses, the causation of chronic respiratory effects in occupationally exposed subjects has not been established. The OSHA cotton dust standard is based on the premise that sustained exposure may result in chronic respiratory problems. To test this hypothesis, the pertinent literature is reviewed and discussed in an attempt to decide if convincing epidemiological documentation exists to support a cause and effect connection between prolonged dust exposure and chronic respiratory impairment. There appears to be a need for additional studies to clarify this important aspect of occupational medicine. 

Recent guidelines entitled Non-clinical Local Tolerance Testing of Medicinal Product from the CPMP refer to the murine local l)unph node assay as a method for the assessment of the induction phase of skin sensitisation. This method measures the ability of compoimds to induce proliferative responses in skin-draining lymph nodes. This method uses fewer animals than alternative in vivo methods and reduces the trauma to which animals are potentially subjected. ... 

In their note, they also commented extensively on the deficiencies of a voluntary system. Grosset and Linstead concluded their note with a plea to set on foot, with or without further enquiry, the preparation of a comprehensive statute dealing with drugs and medicines that will bring the whole field, including the supervision of toxicity testing and clinical trials, under the responsibility of the Health Ministers advised by a central body of experts. ... 

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