Guidelines for the Study and Evaluation

Food and Drug Administration (1993). Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs. Federal Register, Thursday, July 22, 1993. Vol. 58, No. 139, pp. 39405-39416. 

Federal Register. 1993. Guideline for the study and evaluation of gender difference in the clinical evaluation of drugs (58 Fed Reg 39406-16). 

CDER (Center for Drug Evaluation and Research) (1989). Guideline for the Study of Drugs Likely to Be Used in the Elderly. FDA, November, 1989. 

The FPL vertical wall furnace used in our study was described in some detail by Brenden and Chamberlain (6). This furnace is normally used to evaluate the fire endurance of wall assemblies. The basic guidelines for the furnace test method are given in the ASTM E-119 standard (5). The method was designed to evaluate the ability of a structure to withstand a standard fire exposure that simulates a fully developed fire. The furnace is gas fired, and its temperature is controlled to follow a standard time-temperature curve. A load may be applied to the assembly. The failure criterion can be taken as time at burnthrough, structural failure, or a specified temperature rise on the unexposed side of the wall—whichever comes first. The construction of the furnace is not specified in the ASTM E-119 standard. 

In the hazard assessment, it is important to evaluate the toxicological database with regard to its adequacy. The adequacy of a study includes its validity and its relevance. The relevance refers to what has been studied in relation to what is needed for the hazard and risk assessment, and the validity refers to how the study was performed, e.g., conforming with a particular test guideline. The validity and the relevance of a study, or a whole database, has to be considered in relation to the reliability and thus the confidence. The data for hazard assessment are described in detail in Chapter 3. 

The literature gives a wide range of practical guidelines for the evaluation of method performance characteristics [58]. Besides the diversity of approaches, also the terminology and way of reporting results vary widely. Differences may occur depending on the purpose and the application field of the method, and validation studies may become more difficult as the complexity of the analysis increases [86]. In what follows, terms and formulas are taken from the accepted IUPAC nomenclature for the presentation of results of chemical analysis [66]. For each validation parameter, definitions, ways of expression, determination guidehnes, and acceptance criteria are reported in Table 5. 

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