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Good laboratory practice regulatory studies

All UK facilities conducting regulatory studies must be members of the UK Good Laboratory Practice compliance program and all regulatory studies must be conducted... [Pg.193]

Analytical chemistry is a critical component of worker safety, re-entry, and other related studies intended to assess the risk to humans during and subsequent to pesticide applications. The analytical aspect takes on added significance when such studies are intended for submission to the U.S. Environmental Protection Agency and/or other regulatory authorities and are thus required to be conducted according to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Good Laboratory Practice (GLP) Standards, or their equivalent. This presentation will address test, control, and reference substance characterization, use-dilution (tank mix) verification, and specimen (exposure matrix sample) analyses from the perspective of GLP Standards requirements. [Pg.153]

Test facilities in the OECD (Organization for Economic Co-operation and Development) member countries that conduct regulatory studies must comply with the OECD Principles of Good Laboratory Practice (GLP), as set out in Council Decision C(97)186/Final. These are referred to as GLP Principles. GLP came into prominence in the late 1970s in response to some malpractice in research and development activities of pharmaceutical companies and contract... [Pg.16]

Much of what is done (and how it is done) in repeat-dose studies is a response to a number of regulations. Three of these have very broad impact. These are the Good Laboratory Practices requirements, Animal Welfare Act requirements, and regulatory requirements that actually govern study design. [Pg.239]

Regulatory authorities perform the watchdog role to ensure that animal studies comply with Good Laboratory Practice (GLP), clinical trials are... [Pg.209]

The Good Laboratory Practice Guidelines (GLP) have been in existence for non-clinical safety studies since They have progressed through various transitional phases to become guidelines in some countries and regulatory/statutory instruments in others. [Pg.1931]


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