Quality Control in Toxicology

ISBN-13: 9789401171847 / Angielski / Miękka / 2012 / 128 str.

G. E. Paget

Opis

Topics in Toxicology Toxicology is a science that stands at the intersection of several interests and disciplines. These intersecting forces are by no means all scientific since some are legal and some are commercial. All have valid things to say about the conduct and interpretation of toxicity experiments. The practising toxicologist must bear all these sometimes conflicting forces in mind as he carries out his duties. This is especially true, of course, of the toxicologist in industry. Toxicology is also a field in which contract research particularly flourishes and a number of major contract research companies have established over the years a reputation for contributing usefully to the practice of this skill. These contract research organisations are particu larly favoured to develop an appreciation of the problems of the in dustrial toxicologist, since it is very common for such a company to service the toxicological needs of companies in several sectors of industry producing new chemical compounds, and the contract research company, therefore, is aware of a wider diversiy of problems than probably affects a single toxicologist in one industry."

Spis treści

Section One The Regulatory Viewpoint.- 1 Maintaining the creative balance.- 2 A Swedish regulatory viewpoint.- 3 The seven deadly sins—a U.K. view.- Section Two The Industrial Viewpoint.- 4 Some possible effects of the introduction of quality control systems on the discovery and safety evaluation of drugs.- 5 Quality control in an industrial laboratory.- 6 Good Laboratory Practices (GLPs) and the Bioresearch Monitoring Program.- Section Three The Independent Expert.- 7 Quality and integrity assurance.- 8 The importance of experimental design.- Section Four The Research Contractor.- 9 Quality assurance in contract research organizations.- 10 Some problems in good laboratory practice for a contract research laboratory.