Intravenous (IV) or injection delivery in a TQT study requires extra preparation to ensure successful study conduct.

•    Dose administration with an intravenous infusion requires planning to consistently deliver the dose over the defined time interval. Based on Cetero’s experience, we recommend filling empty IV bags with the appropriate volume of diluent and drug. This practice has resulted in more consistent delivery times from participant to participant. Prefilled IV bags tend to have a volume of ± 10% of the labeled volume. This difference can result in variations in the infusion time for the investigational product.

•    Another consideration for an injectable dosage form is the volume of solution to be administered. The volume may require multiple injections to deliver the dose and avoid injection site reactions.

•    Due to the complexity of injectable dosage forms, often it will be necessary to dose smaller groups. The clinical team should work with the pharmacy and nursing teams to plan the dose administration for injectable delivery and the number of subjects that should be dosed in a cohort.