Basics of Designing General Toxicology Studies

Author:

Peri Ravikumar

Publisher

Springer Nature Singapore

Reference30 articles.

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2. Tamaki C, Nagayama T, Hashiba M, Fujiyoshi M, Hizue M, Kodaira H et al (2013) Potentials and limitations of nonclinical safety assessment for predicting clinical adverse drug reactions: correlation analysis of 142 approved drugs in Japan. J Toxicol Sci 38(4):581–598

3. M3(R2) Nonclinical safety studies for the conduct of human clinical trials and marketing. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m3r2-nonclinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorization. Accessed 10 Dec 2022

4. Non-clinical: toxicology. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/non-clinical/non-clinical-toxicology. Accessed 10 Dec 2022

5. Rhomberg LR, Baetcke K, Blancato J, Bus J, Cohen S, Conolly R et al (2007) Issues in the design and interpretation of chronic toxicity and carcinogenicity studies in rodents: approaches to dose selection. Crit Rev Toxicol 37(9):729–837

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