In vitro model of administration of temozolomide injection using micro-pumps during phase 0 clinical trial
LEI Chunpu
WANG Zejuan
QI Lu
Abstract：Objective To develop an in vitro model for temozolomide injection infused by micro-pumps and to assess the performance of micro-pumps so as to guarantee the accuracy of infusion during the phase 0 clinical trial.Methods Twelve micro-pumps were tested under the same conditions, involving temperature, humidity, operators and IV line of the same type. In order to simulate the infusion process of phase 0 clinical trial, the infusion speed and duration were set at 0.8 ml/h and 90 min respectively based on the phase 0 study protocol of temozolomide. Each pump was tested three times and the mean liquid amount was calculated to compare with the theoretical amount.Results The errors of the twelve miro-pumps, ranging from-5％-5％, met the national measurement provision and requirements of micro-pumps used during phase 0 clinical trials, suggesting that the high accuracy of our micro-pumps could guarantee the subsequent administration in the clinical trials.Conclusion It is necessary to attach importance to the use of micro-pumps to ensure the accuracy of administration during the phase 0 clinical trials.
Keywords：phase 0 clinical trialtemozolomide infusedmicro-pumpain vitro model
Publication Date：2017-11-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 395-397 )