This is the fourth volume of Standard Operating Procedures (SOPs)
compiled from documents prepared in these laboratories in part
fulfilment of the requirements of various Good Laboratory Practice
(GLP) regulations and guidelines. SOPs have now become an everyday
feature of work in most industrial and contract toxicology
laboratories. They provide a written definition of the mechanics of
unit operations which together comprise the framework for
experiments in safety evaluation. Metabolic studies and analytical
chemistry are closely linked to toxicology since they embody
essential aspects of the overall assessment of product safety. Some
authorities consider certain parts of these subjects to be outwith
the scope of the GLP requirements but for the reasons stated this
is contrary to our own view. We have tried where possible to define
in SOP format for use in our own laboratories the unit operations
involved in these disciplines and they form the basis of this
volume. Some relevant material from previous volumes has been
brought together in updated form and is also presented here for
completeness. Dr I P Sword Managing Director Inveresk Research
International Musselburgh EH21 7UB Scotland ix Introduction GENERAL
1. The Food and Drug Administration of the US Government published
its Good Laboratory Practice Regulations for Non-Clinical
Laboratory Studies in the Federal Register (22 December 1978). The
Regulations are the culmin ation of a number of years of
investigation into the standards to which safety evaluation studies
were performed in laboratories in the USA."
General
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