International guideline

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

Alrasbi M, Sheikh A Comparison of international guidelines for the emergency medical management of anaphylaxis. Allergy 2007 62 838-841. 

Finally some additional milestones in organization, research and development of RMs need to be mentioned. The large increase in the number of reference materials being produced led in 1975 to the formation of an ISO Council Committee on Reference Materials (ISO-REMCO) charged with the establishment of international guidelines on principles of certification, methods of use, needs, availability and nomenclature (Klich 1999), see also Sections 1.2 and 1.3. 

The particular facility under review is a unit producing a reactive material from a high-burning velocity hydrocarbon. The company has established internal guidelines for evaluating occupied buildings that are exposed to identified explosion hazards. 

Mezzich, J. E., Berganza, C. E., von Cranach, M. etal. (2003). Essentials ofthe WPA International Guidelines for Diagnostic Assessment (IGDA). Br.. Psychiatry. Suppl. 45. 

Proposed international guidelines on ethical issues in medical genetics and genetic services http //wmv.who.int/ncd/ hgn/hgnethic.htm. 

You may have included some other documents with the SOPs and WIs because they are also held in your area of the laboratory. These could be, for example, guides for carrying out particular activities, such as method validation, and international guidelines on how to achieve reliable results. Some areas of activity may be covered by legislation copies of the relevant documents will be kept locally as it may be referenced in the SOP. Equipment manuals are also kept locally. 

Second, meanwhile, no international guidelines have been provided for the manufacture, marketing, and distribution of household insecticides on such a level as those of agricultural chemicals, and not even manufacturing registration is required in some countries. Of course, the minimal required toxicity studies are conducted with synthetic pyrethroids for household insecticides to examine absorption, distribution, metabolism, and genotoxicity in animals. 

Validation is the process of collecting documented evidence that the method performs according to the intended purpose. " The validation characteristics and the acceptance criteria to be applied in validation of HPLC methods for MAA/NDA filings and marketed products should comply with the international guidelines on method validation. Table 11 details validation activities to be conducted for type 1, type 2, and type 3 methods ... 

The quantity of flammable liquids or gases or heated combustibles can be indicative of the need for fixed water spray fire protection. Table 8-4, developed from FM Data Sheet 7-14, suggests quantities of flammables where fixed water spray fire protection should be considered based on one insurance provider s guidance. Some company internal guidelines and practices allow up to 5,000 gal (18,927 I) in the largest vessel before water spray protection is recommended. Additional guidance on fixed fire protection is available in API Publication 2030, Application of Water Spray Systems for Fire Protection in the Petroleum Industry, (API, 1998). 

The SAMM Guidelines have been supplemented by a useful review entitled International Guidelines on Post-authorisation Research and Surveillance by Herbold. ... 

Herbold M. International guidelines on postauthorisation research and surveillance. Pharmacopsychiatry 1997 30 (Suppl) 62Mr. 

Bankowski, Z. editor. International guidelines for ethical review of epidemiological studies. Geneva Counsil for International Organizations of Medical Sciences 1991. 

Clinical treatment recommendations for low back pain based, on 5 international guidelines and on information in the Cochrane database of systematic reviews, can be summarized as follows there remains a lack of consensus regarding reported efficacy of spinal manipulative therapy for the treatment... 

Levine RJ. Some recent developments in the international guidelines on the ethics of research involving human subjects. Annu N Y Acad Sci 2000 918 10-8. 

International guidelines for isophorone were not located. National and state regulations and guidelines pertinent to human exposure to isophorone are summarized in Table 7-1. 

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