Dosing record

In guidance document ICH E3, Structure and Content of Clinical Study Reports, the FDA defines treatment-emergent signs and symptoms (TESS) as events not seen at baseline and events that worsened even if present at baseline. As simple as that may sound, it can sometimes be quite difficult to program. The important data variables that come into play are dosing record dates and times, adverse event start and stop times, and adverse event severity. All of these data variables need to be completed accurately for TESS to be calculated properly. 

The human data, as well as the animal studies indicate that cannabinoids may ameliorate some symptoms of MS. Unfortunately, a definitive large-scale study has yet to be performed. Such a study should take into account that (a) the placebo effect in MS is very high (b) the effective doses recorded are close to, or identical with the doses that cause cannabimimetic effects (c) cannabis (marijuana, hashish) is obviously not identical to zf9-THC, and that other constituents may synergize THC action (d) smoking cannot be compared with oral administration, and (e) the anal route of administration [141] may be a preferred one. 

The dose recorded under this heading in the monographs in Part 2 indicates die usual daily dose (oral unless otherwise stated) that may be administered for therapeutic purposes. It is intended solely as a guide in deciding whether the amount taken by an individual falls within the normal dosage range and should not be taken as a recommendation for treatment. 

Facilities and services for radiation protection and safety must be well established at the national level. These include laboratories for personal dosimetry and environmental monitoring, and calibration and intercomparison of radiation measuring equipment they could also include central registries for radiation dose records and information on equipment reliability. 

A problem with Figure 7.6 is that the horizontal dimension is dominated by the observations at later times, making it hard to see what is going on at earlier time points. One solution to this may be to use a log scale for the time axis. Another is to split the graph and look at different time periods separately. The latter has been done in Figure 7.7, where the data coded as belonging to occasion one is plotted separately. Here we can see that most individuals had hve doses recorded in the data set prior to the first observation while six individuals had observations recorded directly after the first dose event. (This may indicate that these six individuals lacked the dosing history and that the first dose had to be assumed to be a steady-state dose.) It is also obvious that, for most individuals, occasion one was defined to cover... 

Specify sampling time point (value=0 for dosing records) snum.v <- c(rep(0, length(Dosetime.v)), seq(1,length(Obstime.v)))... 

B. Pocket dosimeters provide direct-reading capability that allows the dosimeter to be read at any time while working in a radiation area to get an estimate of the exposure received. The pocket dosimeter shall be read and doses recorded daily in the utilization log. If, at any time, dosimeters read off scale, an emergency situation is considered to exist and the individual s TLD badge and the control badge must be submitted immediately for processing. 

Normal ingestion 0.1 mg/day. Toxic level 5-50 mg/day.Smallest fatal dose recorded 130 mg. ... 

Missing dosing records (i.e., infusion rate not recorded)... 

The retention period for narrative logs, facility drawings, routine release records or estimates, and fuel inventories is the "life of the facility." The retention period for other records, such as unusual occurrence reports involving releases to the enwonment, contamination, and personnel exposure dose records, is 75 years. 

The monitoring practices for radiation workers differ from country to country and the dose recording and reporting practices also vary, e.g., the recording of the dose over the minimum detectable level (MDL), the subtraction of background radiation doses, whether or not internal exposures are included or treated separately. 

In relation to employees who are designated as classified persons, the Regulations require employers to ensure that assessments are made of all significant doses. For this purpose, the employer is to make suitable arrangements with an approved dosimetry service (ADS). The ADS will also keep the dose record for the employer. The purpose of the approval system is to ensure as far as possible that the doses are assessed on the basis of accepted national standards. 

In animals, the bioavailability of Isofl is different from that observed in humans. Globally in rodents, Isofl bioavailability is 10 times lower than in humans the oral doses must be 10 times higher to lead to the plasma doses recorded in humans. Indeed, 20 mg/kg/day of Isofl leads to 610 ng/mL Isofl in rat plasma [122], while 1.4 mg/kg/day leads to 599 ng/mL Isofl in human plasma [123]. However, as mentioned earlier, rodents are intensive S-Eq producers. This is not always the case in humans. Because S-Eq exhibits specific health effects, soy consumption in animals may not induce the same health effects as in humans. In addition, one must remember that soy consumption leads to significant plasma levels of Gen, Daid, S-Eq, and Gly. Therefore, the test of a pure compound cannot be transposed to soy consumption. 

Improving of dose recording using new analysis and tools... 

Health surveillance records should be stored according to national regulations or the recommendations of the regulatory body. The storage period should normally be on a time-scale similar to that for dose records. 

Personal dose records should be available for purposes of review and assessment ... 

All personal dose records should be carefully and periodically assessed by the radiation protection officer and should be examined for the following points ... 

The calculated average daily amount of material administered is recorded in the legend. The sources of these data are contained in the text. (The daily doses recorded for the curves of Jacobson and SubbaRow refer only to the amount of primary factor administered in addition, three accessory factors were administered in the 1937 curve, in a daily amount of 3.4 mg. and five accessory factors were administered in the 1940 curve in a daily amount of 6.2 mg.)... 

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