Safety parameters

Peterson, R. J. et al., 1981, Performance-Based Evaluation of Safety Parameter Display Detection, EG G, Sd-B-81-004, November. 

The effectiveness of the fume cupboard can be expressed in a number of ways. Several of these ways are discussed by Melin and Olaiider. Nordtest defines an escape safety parameter as... 

Woods, D. D., Wise, J. A., Hanes, L. F. (1981). An Evaluation of Nuclear Power Plant Safety Parameter Display Systems. In Proceedings of Human Factors Society 25th Annual Meeting. Santa Monica, CA Human Factors Society, Inc. 

MWD Technology 901. Directional Drilling Parameters 954. Safety Parameters 961. LWD Technology 971. Gamma and Ray Logs 971. Resistivity Logs 974. Neutron-Density Logs 985. 

Methods and timing for assessing, recording, and analysing of safety parameters. 

The vapour pressure of a liquid provides an essential safety parameter and it is mandatory that safety sheets contain these values (when they are known). This parameter is taken into account in some classification methods of inflammability risk. It enables one to determine the equilibrium vapour concentration of a liquid in air. This concentration can then be used to ascertain whether a working environment presents an inflammability risk (by reference to the inflammability limits) or a toxicity hazard (by comparison with the exposure values). 

Warmig L, Christoffersen C, Riis BJ, Stakkestad JA, Delmas PD, Christiansen C (2003) Adverse effects of a SERM (levormeloxifene). Safety parameters and bone mineral density after treatment withdrawal. Maturitas 44 189-199... 

Table 5 illustrates inherent safety parameters and the selection of them by Edwards and Lawrence (1993) and Heikkila et al. (1996). E.g. inventory has been chosen by both. It is relative to the capacity of a process and residence times (hold-up s) in vessels. It has a large effect on the degree of hazard and it should be kept small by intensification. 

Inherent safety parameters (Edwards and Lawrence, 1993) Chosen parameters by Comments... 

In the Chapter 7 the selected inherent safety parameters for conceptual process design were presented. From these parameters an inherent safety index is formed in this Chapter. There is a straight link between inherent safety principles and the inherent safety index as discussed earlier (see Figure 5). 

The number of columns is changing however, if extractive distillation is used. Therefore the fluid inventory in the process becomes a major safety parameter. The inventory depends on the size of the columns in the process. It was assumed that all the columns have been designed for the same superficial vapor velocity. Therefore the column area is directly proportional to the vapor flow rate. Also it was assumed that the liquid hold up is proportional to the column area. 

One major purpose of preclinical (animal) toxicity studies of a potential new drug is to identify the toxic effects which most commonly occur at doses nearest to those to be used in humans. These observations serve to help ensure that care is taken to detect any such effects in humans. Additionally, a broad range of other indicators of adverse drug action may be identified to ensure that their occurrence is looked for. These are also commonly called safety parameters. 

Measuring Safety Parameters. After specific safety parameters are chosen, it is necessary to determine how thorough an evaluation of each parameter should be conducted. It is also possible that different types of examinations would be suitable at different points of a clinical trial. For example, a physical examination may be specified to include more or fewer measurements or facets, and a complete examination may not be necessary or even suitable during some periods of clinical trial. 

Parameters that Measure Either Safety or Efficacy. Certain parameters may, of course, be either safety or efficacy parameters, or both. The electroencephalogram (EEG) is an example. Blood pressure is another. It is thus important to establish clearly in the protocol whether each parameter is being incorporated in the protocol for safety or efficacy evaluations. Almost any safety parameter can be used for measuring efficacy. 

Assessment of safety Specification of safety parameters Methodology of assessing safety parameters Handling of serious adverse events Handling of ordinary adverse events Procedure for breaking codes... 

In most cases, safety monitoring wUt be the major task for a DMC. Even if the safety parameters monitored are not directly related to efficacy, a DMC might need access to unblinded efficacy information to perform a risk/benefit assessment in order to weigh possible safety disadvantages against a possible gain in efficacy. ... 

A safety parameter examples are drop-out rate due to adverse effects, adverse effects measured by a (side-effect-spedfic) rating instrument, biological markers, etc. 

A recent study [12] suggested the use of a new safety parameter, time to threshold (TT). TT indicates the time a threshold temperature rise is exceeded and how long a tissue can be safely exposed to ultrasound, provided the safe threshold is known. 

Lubbers, J., R.T. Hekkenberg, and R.A. Bezemer. 2003. Time to threshold (TT), a safety parameter for heating by diagnostic ultrasound. Ultrasound Med Biol 29 755. 

This type of incident is difficult to predict. Nevertheless, by using a systematic approach to hazard identification it should become clear that any water entering the reactor could lead to an explosion. Therefore when changing some parts of the equipment, even if they are not directly involved in a given process, especially in multi-purpose plants, one should at least consider possible consequences on the safety parameters of the process. 

The determination of the temperature that may be reached in the case of a cooling failure (T is an important safety parameter. The MTSR is the maximum of T i... 

The primary goals of preclinical safety evaluation articulated in ICH S6 are namely (1) to identify an initial safe dose and subsequent dose escalation schemes in humans, (2) to identify potential target organs for toxicity and for the study of whether such toxicity is reversible, and (3) to identify safety parameters for clinical monitoring. These goals are generally accepted across all product classes. 

At the end of such multiple dose studies the animals are killed in terminal anesthesia and maximal blood collection is possible. Therefore, not only the target metabolic parameters (e.g. glucose, lactate, free fatty acids, triglycerides, cholesterol) but also other parameters, which reflect intermediary metabolism (e.g. keton bodies, urea, uric acid) as well as safety parameters (e.g. ASAT, ALAT, AP, LDH) can be determined by clinical chemistry. 

The design of an exploratory assessment of dose linearity/proportionality during the conduct of a first-in-man study for candidate drug (XYZ1234) is presented below. For the purposes of simplicity, the description is limited to the collection, handling, and interpretation of pharmacokinetic data although clearly safety parameters are in the main focus. 

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