Quality Control in Toxicology by Sherwin Gardner (auth.), G. E. Paget (eds.)

By Sherwin Gardner (auth.), G. E. Paget (eds.)

Topics in Toxicology Toxicology is a technological know-how that stands on the intersection of a number of pursuits and disciplines. those intersecting forces are in no way all medical because a few are felony and a few are advertisement. All have legitimate issues to claim concerning the behavior and interpretation of toxicity experiments. The training toxicologist needs to endure a lot of these occasionally conflicting forces in brain as he incorporates out his tasks. this is often very true, after all, of the toxicologist in undefined. Toxicology is additionally a box within which agreement examine quite thrives and a few significant agreement examine businesses have proven through the years a name for contributing usefully to the perform of this ability. those agreement learn corporations are particu­ larly favoured to enhance an appreciation of the issues of the in­ dustrial toxicologist, because it is quite common for the sort of corporation to provider the toxicological wishes of businesses in different sectors of generating new chemicals, and the agreement study corporation, as a result, knows a much wider diversiy of difficulties than most likely impacts a unmarried toxicologist in a single industry.

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The conceptual scientist is exploring new territory and it would be quite impossible to write out a detailed protocol before the work is undertaken. In addition, the type of scientist who discovers a new significant drug is not the sort of person who works according to a 'cookery book' and very often he is unconventional in his approach. Indeed, it may be said that these very qualities are 50 QUALITY CONTROL IN TOXICOLOGY required for true discoveries. I should be very unhappy if I thought that this type of individual would be put off coming into industry where his talents could lead to important new discoveries.

In other cases intentional sins of commission may be committed in non adherence to the protocol and this may be done for many reasons, few of which are justifiable. 4. INCOMPETENCE OF STAFF-INADEQUATE TRAINING AND SLOTH To those who design protocols and interpret toxicological data these studies can be interesting, but to those technicians who have the day to day running of the study they can be tediously repetitive and boring. Boredom leads to loss of interest, careless work and sloth. In this boredom factor lies a major problem in the quality of these studies, and the longer the duration of the study the greater this quality problem.

It is therefore a matter of very considerable concern that some toxicity studies that are initiated are poorly designed, or are inappropriate with respect to evaluating the agent in the manner in which human exposure occurs, or are not designed to generate the maximum amount of relevant information that could be obtained for little extra burden in time or cost. Other studies are seen which are (i) poorly conducted (ii) inaccurately recorded and (iii) incompletely documented. Toxicity studies that are: (i) defective in protocol design (ii) inappropriate and irrelevan t (iii) conducted in a slovenly manner so that a maximum amount of useful data are not generated (iv) dishonestly reported are a waste of money, a useless expenditure of valuable time and an unjustifiable use of experimental animals.

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