Sword i p (7 Ergebnisse)
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Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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.
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Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - When Volume 1 (Toxicolpgy) in this series of Standard Operating Procedures was pub lished in early 1979, the FDA's Good Laboratory Practice Regulations did not have the force of United States Law, but nevertheless had a substantial impact on the cond…uct of toxicology in laboratories throughout the world. These Regulations are now in force, and Volume 2 (Pathology) was published later the same year. Our critics have implied that we have attempted to reduce toxicology to the level of the cookery book, or alternatively that we seek to impose our standards on others, In some sinister way ensuring that the IRI code will become the international norm. We dismiss these criticisms as arrant nonsense. The many thousands of volumes already sold worldwide can provide at best a framework for adaptation to suit local laboratory condi tions, and thus speed to GLP compliance those organisations which might otherwise have remained foundering at the starting post. If Volumes 1 and 2 of this series have con tributed anything to the conduct of toxicology it must surely be in those non-English speaking nations which, because of the international nature of pharmaceutical and chemical trading, are required by commercial pressures to be in compliance with a foreign law formulated in unfamiliar terminology and introduced for reasons that are not immediately obvious. Much has happened in the short period of time since Volumes 1 and 2 were published.
