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Examples of species differences in drug sensitivity

ICH S7A ICH Harmonized Tripartite Guidelines on Safety Pharmacology Studies for Human Pharmaceuticals, 2001. [Pg.119]

Thatte, L., and Vaamonde, C.A., Drug-induced nephrotoxicity. Postgrad. Med., 1996,100 83-100. [Pg.119]

Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing and Labeling, Draft Guidance, Rockville, MD FDA, March, 2010. [Pg.119]

Hoffman, D., et al.. Performance of novel kidney biomarkers in prechnical toxicity studies, Toxicol. Sci., 2010,116 8-22. [Pg.119]

Cockroft, D.W., and Gault, M.H., Prediction of creatinine clearance from serum creatinine. Nephron, 1976,16 31—41. [Pg.119]


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