Procedure related factors

Vander Heyden, Y., Questier, R, and Massart, D. L. (1998). A mggedness test strategy for procedure related factors experimental set-up and interpretation. /. Pharm. Biomed. Anal. 17, 153-168. 

From the definitions given above it can be seen that there are two approaches to ruggedness testing (also equal to levels 1 and 2 given in the Acceptable Methods document [14]). In the first approach factors to be examined are selected from the set of operating and environmental conditions that are or could be stipulated in the analytical procedure. This kind of factors can be called procedure related factors. 

In the second approach non-procedure related factors are considered. Factors such as e.g. different laboratories, different analysts, different instruments, different lots of reagents, different days, different columns for HPLC methods or different plates for TLC methods are then examined. 

In the literature, ruggedness tests concern mainly procedure related factors, but occasionally one of the other factors, e.g. a column factor in HPLC, is examined. This will be discussed further in more detail (see Sections 3.4.2 and 3.4.4.4). The examination of the non-procedure related factors in ruggedness testing is described less frequently and requires another approach than the examination of procedure related factors. 

In Section 3.4 the strategy and the different possibilities for performing a ruggedness test when mainly procedure related factors are examined will be reviewed. In a later part (Section 3.5) ruggedness testing of nonprocedure related factors will be discussed. 

RUGGEDNESS TESTING OF NON-PROCEDURE RELATED FACTORS THE USE OF NESTED DESIGNS... 

The examination of more than one of the non-procedure related factors (e.g. different laboratories, analysts, instruments, columns or batches of reagents, days) by Plackett-Burman and fractional factorial designs causes problems. These designs require combinations that are impossible to... 

The ruggedness of a method can be tested using two types of experimental designs. Procedure related factors at the one hand are examined mainly in screening designs of the Plackett-Burman or... 

Karl HW, Cote CJ, McCubbin MM, Kelley M, Liebelt E, Kaufman S, Burkhart K, Albers G, Wasserman G. Intravenous midazolam for sedation of children undergoing procedures an analysis of age- and procedure-related factors. Pediatr Emerg Care 1999 15(3) 167-72. 

The selected factors are either mixture-related, quantitative (continuous), or qualitative (discrete).A mixture-related factor is, for instance, the fraction organic solvent in the buffer system. Examples of quantitative factors are the electrolyte concentration, the buffer pH, the capillary temperature, and the voltage, and of qualitative factors the manufacturer or the batch number of a reagent, solvent, or capillary. Sample concentration (see Table 1) is a factor sometimes included. However, the aim of the method tested is to determine this concentration through the measured signal, from a calibration procedure. Thus, one evaluates the influence of the sample concentration on the sample concentration, which we do not consider a good idea. 

Chapter 3 describes basic mechanical testing procedures. This chapter describes various structural-related factors which affect polymeric mechanical properties. 

ORGANOLEPTIC. A term widely used to describe consumer testing procedures for food products, perfumes, wines, and the like in which samples of various products, flavors, etc. are submitted to groups or panels. Such tests are a valuable aid in determining the acceptance of tlie products and thns may be viewed as a marketing technique, They also serve psychological purposes and are an important means of e valuating the subjective aspects of taste, odor, color, and related factors, The physical and chemical characteristics of foods are stimuli for the eye, ear, skin, nose, and mouth, whose receptors initiate impulses that travel to the brain, where perception occurs. 

From this point the analytical department assumes leadership and begins by selecting the analytical technique. The selection process is dependent upon several related factors, including the analyte itself and the level of measurement precision required. Once the technique has been chosen, a suitable method is identified either from modification of an existing method or the development of a new method. Upon successful demonstration of method feasibility, the technical team members, in collaboration with the regulatory professionals, draft a test procedure and a validation protocol. 

Preventing CIN is of particular importance in patients with diabetes and chronic kidney disease, as these are two of the most powerful independent risk factors for CIN (77), Diabetics are more susceptible to (CIN) than are the nondiabetics, and diabetics with pre-existing chronic kidney disease (CKD) are at even greater risk (78). In a recently proposed CIN risk-scoring system, patient characteristics such as diabetes, age >75, chronic congestive heart failure, admission with acute pulmonary edema, hypotension, anemia and chronic kidney disease and various procedure-related characteristics including increasing volumes of contrast media, and intra-aortic balloon pump use were all found to reliably contribute to increased risk (79). 

The risk of a surgical site infection (SSI) is determined from both the type of surgery and patient-specific risk factors however, most commonly used classification systems only account for procedure-related risk factors. 

SSI incidence depends on both procedure- and patient-related factors. Traditionally, the risk for SSIs has been stratified by surgical procedure in a classification system developed by the National... 

Independently of the chosen concept, reliability and trust between actors as well as transparency of aU procedures related to the logistic chain are key factors for smooth operations. Modern communication technology and standard communication routines ensure maximum transparency. GPS maps ensure easy finding of the raw material for example in the forest, and raw material tracking systems ensure control of material flow as well as allocation of the raw material back to farmers and small private forest ovmers. The latter is a precondition for correct and prompt billing. 

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