Analysis safety data

While material safety data sheets (MSDS) provide important information they may not provide information on all hazards that may be encountered during processing. A review of the MSDS is not a substitute for conducting a process hazards analysis. Additional information to consider should include ... 

Obtain all available information about the material. If it is a surplus or off-specification product, obtain an analysis or a Material Safety Data Sheet. If it is a waste, check for previous analyses, and if none exists, obtain one. (Even if a previous analysis exists, consider running a few screening-type field analyses for confirmation of important properties such as pH, redox potential, or other oxidizer test such as cyanide, sulfide, and flashpoint.)... 

Complete and accurate written documentation of chemicals properties, process teclinology, and process equipment is essential to the PSM program and to a process hazards analysis (PrHA). This information serves many users including the PrHA team. The needed chemical information includes fire and explosion characteristics, reactivity hazards, safety and health hazards and the corrosion and erosion effects. Current material safety data sheet (MSDS ) information helps meet this requirement, but must be supplemented with process chemistry information regarding runaway reactions, and over-pressure hazards. 

Section 10.2 Toxicology Principles Section 10.3 Epidemiology Principles Section 10.4 Molecular/Atomic Structural Analysis Section 10.5 Material Safety Data Sheet (MSDS)... 

Cholesterol Treatment Trialists (CTT) Collaborators (2005) Efficacy and safety of cholesterol-lowering treatment prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins. Lancet 366 1267-1278... 

If testing involves a new product that is not yet in commercial trade, the manufacturer should ship products from the same batch of the same formulation to each test location. The most recent product quality analysis and an appropriate Material Safety Data Sheet (MSDS) must accompany the product shipment. The shipping documents and the certificate of analysis for each shipment must be archived in the raw data for the report. If the residue testing is being done to register a new use for a commercial product, the Study Director must make sure that the product available in each location is the same formulation and that each different batch encountered has its own certificate of analysis to be archived along with a copy of the label and product quality analysis of the material used for the test. Material shipped in noncommercial containers must... 

The analysis of safety data may require larger data sets, so care in ensuring that a consistent phenotype is collected will be important. Furthermore, the benefit to the drug development program could be that additional data to predict adverse events could be available at the time a drug is marketed. 

Drug Levels in Plasma. Drug levels may also be measured in a clinical trial. Such levels are usually part of a pharmacokinetic analysis but also provide important safety data. This information would be particularly relevant in cases of suspected or actual drug overdosage, drug interactions, to correlate medicine levels with toxic events, or in other situations. It must be clarified whether free levels of the drug and/or the protein bound will be measured by the laboratory. 

There are now common practices in the analysis of safety data, though they are not necessarily the best. These are discussed in the remainder of this chapter, which seeks to review statistical methods on a use-by-use basis and to provide a foundation for the selection of alternatives in specific situations. Some of the newer available methodologies (meta-analysis and Bayesian approaches) should be kept in mind, however. 

Local Emergency Planning Committee Layer of Protection Analysis Methyl Isocyanate Minimum Ignition Energy Management of Change Material Safety Data Sheet Not Applicable... 

Periodic review of interim analysis of safety data by DSMB... 

Dow Chemieal Company (1999) Material Safety Data Sheet Diethanolamine, Midland, MI Dutertre-Catella, H., Lieh, N.R, Huyen, VN. Truhaut, R. (1982) Comparative study of skin and eye irritation by ethanolamines (mono, di, tri and poly). Arch. mal. prof, 43, 455 60 Eisen, E.A., Tolbert, RE., Monson, R.R. Smith, T.J. (1992) Mortality studies of maehining fluid exposure in the automobile industry. I A standardized mortality ratio analysis. Am. J. ind. Med., 22, 809-824... 

Qotet B, Bellos N, Mohna JM, Cooper D, et al. 2007. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2 A pooled subgroup analysis of data from two randomized trials. Lancet. 369 1169-1178. 

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