Tolerable Levels of Nonclinical Vehicles and Formulations Used in Studies by Multiple Routes in Multiple Species With Notes on Methods to Improve Utility

• Published in: International journal of toxicology Vol. 35; no. 2; p. 95
• Main Authors: Gad, Shayne Cox, Spainhour, Charles B, Shoemake, Catherine, Pallman, Danielle R Stackhouse, Stricker-Krongrad, Alain, Downing, Philip A, Seals, Richard E, Eagle, Leslie Anne, Polhamus, Kara, Daly, Jennifer
• Format: Journal Article
• Language: English
• Published: United States 01.03.2016
• Subjects: Animals; Dose-Response Relationship, Drug; Drug Administration Routes; Species Specificity; Toxicity Tests; nonclinical studies; routes; species; safety; formulation; vehicles; animals; excipients

Formulation of nonclinical evaluations is a challenge, with the fundamental need to achieve multiples of the clinical exposure complicated by differences in species and routes of administration-specific tolerances, depending on concentrations, volumes, dosing regimen, duration of each administration...