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By Gerhard J. Nohynek

Written in this sort of approach as to make it obtainable to toxicologists who shouldn't have English as a primary language, this ebook specializes in comparing, studying and reporting result of regulatory toxicology reports.

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Presenting Toxicology Results

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The results of the present study will be compared with the results of a previous acute toxicity study performed in mice on the parent compound, PP 16569. Mice were chosen as test animals because this species is commonly used for acute toxicity testing of anticancer drugs. The high dose level, 100 mg/kg, was limited by the solubility of the test compound in the vehicle (5% aqueous glucose solution containing 12% Tween® 80). 2 Introduction of a carcinogenicity study PP 83211 is an antiarhythmic agent under development for use in the prevention of ventricular fibrillation.

G. embryofetal toxicity) studies, the Conclusion should attempt to relate maternal toxicity to fetal observations and identify the dose level at which no fetal or maternal effects were observed. The presence or absence of fetotoxic effects should always be stated. The Conclusion of maternal toxicity studies performed as range-finding studies for subsequent fetal-/ embryotoxicity studies should principally address maternally toxic dose levels. Fetal effects are of secondary interest in such studies and should therefore be interpreted conservatively.

Note the difference between “require” and “necessitate” (“The patient required treatment”; “the patient’s condition necessitated treatment”), although few will criticize indiscriminate usage. 2 “On the opposite” does not exist. Be careful when using “On the contrary” and “In contrast”: • “Creatinine levels did not rise. ” • “Creatinine levels rose. ” 3 This is not important, but “Based on previous findings, we…” implies that “we” were “based on”. 4 Unless you are talking about a mixture of identified proteins, use the generic term “protein”.

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