Dosing Types

When building your dosing schedule, Bluefin supports three kinds of dosing type assignments:

Fixed doses is the simplest method to assign doses to participants. Use "Fixed" when you want a consistent dose for the entirety of the dosing schedule and when doses do not vary between participants within the same schedule.

The default dosing type is "Fixed" when unspecified. Disabling weight-based or body-surface-area-based dosing on the scenario will update existing dose assignments to "Fixed".

Weight-based dosing describes dosing by the weight of a participant in kilograms (kg).

As pictured, weight-based dosing assignments must be enabled under the Dosing tab's options. Once enabled, each dose assignment can be switched to "By Weight" mode.

When enabled, Bluefin will use the provided rate along with the quantity and unit of the corresponding part to calculate the minimum units to be dispensed. This quantity and unit can be configured on the Parts page under the Details tab.

Weight-base dosing supports automatically increasing dose quantity for participants under the age of 20 years old, where increases in weight over the course of the study is expected. Bluefin uses the Growth Charts provided by the CDC. This is particularly useful when forecasting long-term studies involving pediatric subjects where weight growth can be significant.

Body-surface-area-based dosing describes dosing by the body surface area (BSA) of a participant in meters-squared (m²). When relevant, Bluefin uses the Du Bois formula to derive the BSA from a participant's weight and height.

As pictured, body-surface-area-based dosing assignments must be enabled under the Dosing tab's options. Once enabled, each dose assignment can be switched to "By Body Surface Area" mode.

When enabled, Bluefin will use the provided rate along with the quantity and unit of the corresponding part to calculate the minimum units to be dispensed. This quantity and unit can be configured on the Parts page under the Details tab.

Unlike weight-base dosing assignments, only the initial body surface area of a participant is considered for the duration of the study. Contact us if using "Body Surface Area" dosing is desirable with pediatric participants or other studies where you anticipate it changing over time.