Description of study

For those substances for which appropriate human smdies are available, the so-called average relative risk model has been used. Quantitative assessments using this model comprises four steps (1) selection of studies (2) standardized description of study results in terms of relative risk, exposure level, and duration of exposure (3) extrapolation towards zero dose and (4) application to a general (hypothetical) population. 

Name and description of study drug Justification for the route and dosage Population to be treated... 

Membership organization sponsored by the Office of Pesticide Programs of the U.S. Environmental Protection Agency that maintains the National Pesticide Information Retrieval Service (NPIRS), which provides current information on products registered with the EPA and tolerance data for pesticides and hazardous chemicals. It also provides state registration information, registration guideline information, and descriptions of studies on pesticides and hazardous chemicals. 

To maintain a focus on the use of tracers in DOM fractions, this chapter will present only brief descriptions of studies of bulk DOM properties, and will focus primarily on the use of trace moieties from the fulvic acid fraction in freshwater aquatic environments. In addition to being a major DOM fraction, fulvic acid is biogeochemically reactive in natural waters (see Maranger and Pullin, Chapter 8 Chin, Chapter 7 Moran and Covert, Chapter 10). Furthermore, current fractionation methods allow for relatively straightforward isolation of small quantities of fulvic acid from small volume filtered water samples (100-200 mL) in a reproducible manner, as well as for isolation of larger preparative quantities of material. We present examples to illustrate the use of particular trace moieties but do not present a comprehensive review of each trace moiety. 

Fig. 1. Description of studied bioreactor configurations 1, STR 2) STR modified through addition of marbles 3, STR modified through insertion of a metal perforated cylinder 4, FBR.

Nesbitt, H.J., Watson, J.R. (1980a) Degradation of the herbicide 2,4-D in river water-I. Description of study area and survey of rate determining factors. Water Res. 14, 1683-1688. 

Reviews on hemoglobinopathies often contain a detailed description of studies pertaining to the distribution of hemoglobin variants the most comprehensive review has been given by F. B. Livingstone (L30). 

This chapter follows the pattern of previous Reports with the various sesquiterpenoids considered in structural groups based on their postulated or established biosynthesis. Interest in sesquiterpenoid structure, synthesis, and biosynthesis has continued at a high level during the period covered by the present Report. Two excellent reviews have been published one provides an up-to-date account of sesquiterpenoid biosynthesis while the other provides an authoritative description of studies on sesquiterpenoid stress compounds. Stress metabolites are produced by plants after infection with fungi, bacteria, and viruses or after mechanical wounding, irradiation with u.v. light, dehydration, cold, or treatment with phytotoxic agents. 

Explanation that the study is a research procedure Description of study type and research aims Description of study medications/devices Description of procedures to be followed... 

Although most toxicological data reviewed in this profile have been obtained from studies in which PCB mixtures were used, Section 3.4.3 (Metabolism) in particular, contains descriptions of studies in which individual PCB congeners were used. This supplemental information is considered necessary since most of the current knowledge regarding biotransformation of chlorinated biphenyls in experimental animals has been derived from such studies. Table 4-2 lists the lUPAC number of the congeners and the corresponding chlorine substitution. 

Picosecond fluorescence spectroscopy has allowed direct observation of a hydrocarbon singlet 1,3-diradical from (77b),and detailed descriptions of studies on the decomposition of (77b) have been published in full. ° Flash vacuum pyrolysis of (80) and of (81) and further details of the thermal and photochemical decomposition of (82) ° have been described. 

A description of studies used in assessing carcinogenic risk is given below. Epidemiological studies... 

As in any study involving human research volunteers, an Institutional Review Board (IRB) must approve the study protocol and consent from. When the IRB office has released the stamped consent form to the investigator, participants can he enrolled in the study. The consent form consists of a description of study procedures, any risks that are involved, monetary compensation if any, and investigators contact information should participants have questions or concerns. When a participant understands all aspects of the study and potential risks, the investigator and participant sign the consent form a copy is given to the participant. 

A description (e.g., in a table) of studies. Xia et al. (2011) provide an example of such a table. At a minimum, the table should include the planned Phase 2 and 3 studies. The description of studies includes study design (e.g., fixed versus flexible dose, parallel versus crossover), dosing schedule, study location, treatment groups and doses, number of subjects planned (by treatment group and doses), patient population (e.g., based on planned indication, special age groups), and duration of study. 

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