Guidance on Safety

Guidance on Safety, Occupational Health and Environmental Protection Auditing (1991)... 

Recent US FDA guidance on safety testing of drug metabolites [5] highlights the importance of measuring major metabolites in human and toxicological species. This increased scrutiny on the role of metabolites in the evaluation of efficacy and safety will lead to increasing demand for metabolites as analytical standards. 

In the EU, the CPMP issued a draft Note for Guidance on Safety Pharmacology Studies in Medicinal Product Development in 1998, but it has not yet been finalized or put in force, and as of the middle of 2001, USFDA has remained mute on guidelines. 

CPMP (1998). Note for Guidance on Safety Pharmacology Studies in Medicinal Product Development. 

FDA—Draft Guidance on Safety Testing on Drug Metabolites is Published... 

FDA—Guidance on Safety Testing on No major changes to recommendations Drug Metabolites is Published provided in the Draft Guidance. 

FDA s guidance on safety testing on drug metabolites (Food and Drug Administration, 2008), Metabolites that form chemically reactive intermediates can be difficult to detect and measure because of their short half-lives. However, they can form stable products (e.g., glutathione conjugates) that can be measured and, therefore, may eliminate the need for further evaluation. ... 

The ICHS7A guidance on safety pharmacological studies for human pharmaceuticals (The European Agency for the Evaluation of Medicinal Products. Human Medicine Evaluation Unit 2000) states... 

Organization for Economic Coordination and Development (OECD), Guidance on Safety Performance Indicators related to Chemical Accident Prevention, Preparedness and Response for Industry, 2nd Edition, OECD Environment, Health and Safety Publications, Series on Chemical Accidents No. 19, Paris, 2008 Phimister, J. et al., Near-Miss Incident Management in the Chemical Process Industry, Risk Analysis, Vol. 23, No. 3,2003... 

Bode G, Olejniczak K. ICH topic The draft ICH S7B step 2 Note for guidance on safety pharmacology studies for human pharmaceuticals. Fundam Clin Pharmacol. (2002) 16(2) 79-81. 

This is the latest volume in a series on ammonia plant safety. These technical manuals give guidance on safety development, accident prevention, and efficient plant operation. Topics In Volume 32 Include risk analysis and emergency management of ammonia Installations, ammonia detectors, tank storage, safety assurance programs, and other topics in specific manufacturing operations. 

ISO 10381-3 2001 Soil quality - Sampling - Part 3 Guidance on safety. 

The guidance on safety reads Night lights and stubby candles are almost impossible to knock over. All naked flames are best used in a metal tray. 

Organisation of Economic Go-operation and Development (OEGD) (2003) Guidance on Safety Performance Indicators. Guidance for industry, public authorities and communities for developing SPI programmes related to chemical accident prevention, preparedness and response. OECD Envirorrment, Health and Safety Publications. Series on Chemical Accidents, No. 11. OECD Paris. 

The Merchant Shipping Act 1995 is an Act to consolidate the Merchant Shipping Acts 1894 to 1994 and other enactments relating to merchant shipping. It is in 13 Parts and covers the registration and operation of British ships and seamen. Part III -Masters and Seamen, contains a section on safety, health and welfare in terms of conditions for crew. Part IV - Safety, contains general guidance on safety and health on ships. The full text of the Act can be found on the HMSO web site at www.hmso.gov.uk/acts. 

Good guidance on safety legislation, design and procurement relating to linkspans and walkways... 

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