Juvenile toxicity studies considerations – not just “mini” general tox!

Outlining a pediatric clinical and safety assessment plan for investigational drugs is a required part of drug development due to regulatory legislation. These plans may include juvenile toxicity studies in animals to ensure safe and effective medicines for children. Juvenile toxicity studies are warranted when safety concerns can’t be adequately, ethically, or safely assessed in … Continued

Solving a Mystery Using PBPK: How Drug-excipient Complexes Can Confound a Metabolic DDI Result

Assessment of drug-drug interaction (DDI) liabilities is an important safety component of any drug development program. Itraconazole, a selective strong inhibitor of CYP3A, has been widely employed to determine the maximum drug interaction risk with new molecular entities as CYP3A substrates. Hydroxypropyl-β-cyclo-dextrin (HP-β-CD) is used as an excipient in the itraconazole solution for oral dosing … Continued

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