Pharmacokinetic-Pharmacodynamic Modeling in Drug Development: Comments and Applications
Hartmut Derendorf, Günther Hochhaus in Handbook of Pharmacokinetic/Pharmacodynamic Correlation, 2019
A form of survival analysis was developed by Cox46 to describe, in a semiparametric manner, the hazard or risk of a certain event occurring by a certain time as a function of a baseline hazard and a relative risk term. This type of model has been used to model the risk of relapse during methotrexate maintenance in the treatment of acute lymphoblastic leukemia,47 and for the assessment of the risk of developing renal dysfunction during cyclosporine therapy.48 In these cases, the concentration ranges of the compounds of interest are treated as categorical data; the results of these analyses are seen in Figures 15 and 16. This method of analysis utilizes multivariate analysis and complex statistical models, but is useful for analyzing these types of data. The analyses are data-intensive, requiring large numbers of subjects and multiple determinations of clinical status for each subject. However, this method does take into account other covariates that may affect clinical outcome. In the case of methotrexate, covariates other than methotrexate which affected outcome included serum hemoglobin and white blood cell count.47 Hazard analysis is observational in nature; the results of these exploratory analyses need to be confirmed by further study.
Microbiological control of raw materials
R. M. Baird, S. F. Bloomfield in Microbial quality assurance in cosmetics, toiletries and non-sterile Pharmaceuticals, 2017
This is a most important area. The purpose of taking a sample is to judge the quality of the whole batch on the results of the tests performed upon the sample. This presupposes that microbial contamination is homogeneously dispersed throughout the material being sampled. This may or may not be true. In general, aqueous solutions and suspensions and their microbial flora are assumed to be homogeneous. Non-aqueous materials may not be assumed to be equally contaminated, as, for example, where oils become contaminated with small quantities of water. Therefore, although sampling theory normally demands a random sample, this may not be appropriate for the microbiological sample. If the process of manufacture is known, then samples may be taken from the known vulnerable points. This approach is known as hazard analysis of critical control points. If not, then random sampling has to be used but the interpretation of results, including the use of resampling is more difficult. Hazard analysis of critical control points, which is a system whereby the vulnerable points in a process are monitored to ensure the system is in control, is discussed in more detail in chapter 4.
Hazard Identification
Samuel C. Morris in Cancer Risk Assessment, 2020
In addition to sources listed earlier, general references are often used to determine hazard (e.g., Sax, 1975; Clayton and Clayton, 1978). The National Research Council (e.g., NAS, 1972; 1980; 1981a; 1981b); and the World Health Organization (e.g., WHO, 1981) publish reviews of specific agents or groups of agents. Hazard analyses also may compare measured or estimated exposures to some standard: an environmental or occupational exposure standard (e.g., NIOSH/OSHA, 1978), for example, or may draw on existing epidemiological or toxicological literature and use findings for similar situations to make a first estimate of the potential hazard in a new situation. Some scientific and professional journals which have proved useful in this regard are listed in Table 3-11. Basically, any and all sources of information should be drawn upon for a hazard analysis.
Application of fuzzy fault tree analysis based on modified fuzzy AHP and fuzzy TOPSIS for fire and explosion in the process industry
Published in International Journal of Occupational Safety and Ergonomics, 2020
Mohammad Yazdi, Orhan Korhan, Sahand Daneshvar
In recent years, complex chemical plants have been developed rapidly to meet the increasing demands of the process industries [1]. As these plants usually make use of hazardous materials, their failure has the potential to cause serious harm, to both people and the environment [2]. For this reason, it is necessary to recognize the potential risks that are associated with the specified system and then take measures to minimize them. To deal with a large number of accidents, incidents, near misses and mishaps in the process industries, different risk assessment approaches have been developed and widely used to perform hazard analysis in order to enable the prevention of inadvertent incidents and plan for taking actions toward mitigating their effects [3]. According to Standard No. IEC 61025:2006 [4], fault tree analysis (FTA) is a well-known risk assessment technique with a logical diagrammatical method for evaluating the probability of an accident caused by series of faults and failure events.
Hazard function deployment: a QFD-based tool for the assessment of working tasks – a practical study in the construction industry
Published in International Journal of Occupational Safety and Ergonomics, 2020
Mario Fargnoli, Mara Lombardi, Nicolas Haber, Francesco Guadagno
A more comprehensive approach based on the QFD method is that presented by Bas [35]. In this study, a three-phase approach is represented (Figure 3), where three HoQs are used to consider the relationships between tasks and hazards, hazards and events, and events compared with preventive and protective measures. Compared with the former study, this framework presents a more complete risk assessment approach since: the hazard analysis follows a bottom-up approach [49];it enables analysis of the relationships between the hazards and the possible preventive/protective measures;the final priority weight of the events (in Phase III) considers the probability of occurrence, the expected economic cost of each event and the expected consequences of the events.
The effect of educational intervention on promoting safe behaviors in textile workers
Published in International Journal of Occupational Safety and Ergonomics, 2022
Farideh Hatami, Rayhane Kakavand
Workers were randomly selected from three different shifts of the production line in the fields of spinning, weaving, weaving preparations and dyeing. To prevent bias in the results of this study, participants in each of the study groups were selected based on risk factors of worksites, literacy levels and age. In addition, the majority of participants in the study groups had an acceptable level of literacy. In this study, in order to identify the factors affecting safety behaviors based on the combination model while directly observing the intangible behavior of employees, three group discussion meetings were held with middle managers. The beginning of the discussion was a brief summary of the plan and the objectives were described. Furthermore, behavioral hazard analysis was used to identify risky behaviors and these risks can be determined using accident/incident reports, job hazards analysis, employee interviews and brainstorming. Thus, while identifying our 23 items, we categorized them under three categories of personal, environmental and organizational factors (Table 1).
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