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Название: Product safety evaluation handbook
Автор: Gad S.C.
This new edition of the Handbook has been expanded and thoroughly revised to reflect the changes
both in the science/practice of toxicology and in regulatory and statutory requirements that have
occurred since the first edition was published over ten years ago. The objective remains the same—to
provide a single volume, practical handbook that will meet the everyday needs of those involved in or
responsible for ensuring the biologic safety of products other than drugs and medical devices.
To meet this objective, significant attention has been paid to reviewing relevant U.S. and international
guidelines that are applicable to the performance of each category of tests. Additionally, wherever
possible alternative testing schemes that involve fewer or no intact higher animals have been introduced
and incorporated. The entirely new chapter on pharmaco- and toxicokinetics was likewise added to
reflect the fact that in many cases such studies are now essential to allow a meaningful assessment of
potential harm and the relevance to humans of findings in animal test models.