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Study initiation date, definition

Many of you have expressed an interest in a format for your master schedule. Figure 1 depicts the format Mobay Chemical Corp. uses. It is self explanatory and covers the items required in the GLP regulations (test substance test system nature of study study initiation date current status sponsor identity, if explicable and name of study director). For a contract laboratory, the sponsor s identity must appear on the master schedule sheet for each study listed. There are several terms that require definition. In... [Pg.84]

In summary, while only the NEI initiated AREDS II study is a large enough RCT to have the potential to provide definitive evidence as to whether the macular xanthophylls can indeed reduce the risk of AMD, the evidence available to date that lutein and zeaxanthin could contribute to this is not only biologically plausible but also supported by various experimental, epidemiological, and small-scale clinical studies. Although the benefits of lutein and zeaxanthin in this respect may be moderate to small, their safety is well documented. [Pg.272]

The use of anhydrous perchloric acid as a catalyst for caticniic pdiymerisation dates from 1960, when Tauber and Eastham publidied a study of the interaction of this catalyst with 2-butene in 1,2-dichloroethane. The ccanplex behaviour of this stem did not permit any definite conclusion about the reactions invdved, but the possibility of initial formation of /so-butyl perchlorate was seriouriy considered. Today the formatiem of alkyl perchlorates is well documented as discussed in Sect. II-I, except for tertiary ones. Plesch and Westermann noticed that isotxitene did not pdymerise in CH2O2 when perchloric acid was mixed with it, but only gave r-hutyl perchlorate. [Pg.76]

The detailed case records of these 1000 were then analyzed quite independently by Dr. Frances Meuli, M.B., Ch.B. (Otago, New Zealand), who established their presentation date of untreatability by such conventional standards as the establishment of inoperability at laparotomy, the abandonment of any definitive form of anti-cancer treatment, or the final date of admission for terminal care. This presentation date of untreatability corresponds to the date when ascorbate supplementation was initiated in the treated group. Comparable survival times of the 10 matched controls could then be calculated. We accept that the presentation date of untreatability can be influenced by many factors in individual patients, but we contend that the use of 1(K)0 controls managed by the same clinicians in the same hospital over the last 10 years provides a sound basis for this comparative study. We record our thanks to Dr. Meuli for her unbiased and valuable contribution to this investigation. [Pg.588]


See other pages where Study initiation date, definition is mentioned: [Pg.85]    [Pg.59]    [Pg.259]    [Pg.433]    [Pg.481]    [Pg.523]    [Pg.713]    [Pg.3195]   


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