Statistical considerations on real time and extended controlled temperature conditions (ECTC) stability data analysis of vaccines.

ABSTRACT:

Background

Although maintaining vaccines in a strict cold chain has cost and logistical implications in low- and middle-income countries, only a few vaccines have obtained approval for extended controlled temperature conditions (ECTC) application, which permits the administration of vaccines after storage outside of the cold chain for a defined period. We developed a methodology to evaluate stability data and calculate minimum release potency (MRP) in support of ECTC application.

Methods

The methodology is focused on statistical considerations consisting of stability data collection, statistical analysis plan, statistical modelling, and statistical report. It uses mock stability data from a hypothetical product and may serve as a helpful guide for other products. The statist

SUBMITTER: Kim DR 

PROVIDER: S-EPMC10560890 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature