Clinical pathology for preclinical safety assessment: current global guidelines.
Regulatory guidelines for preclinical safety assessment studies of new drugs, chemicals, and food additives exist in many large industrial countries. Current guidelines include recommendations or requirements for clinical pathology testing. Many of the testing requirements are similar for every country, but others are not. The similarities and differences among several of the guidelines are discussed, and specific instances of ambiguous or inappropriate testing requirements are cited.
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D000818:Animals; D015197:Carcinogenicity Tests; D002624:Chemistry, Clinical; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D010338:Pathology, Clinical / Q000592:standards*; D014116:Toxicology / Q000592:standards*; D016482:Urinalysis