Claude Ammann Consulting, Epalinges, Switzerland.
AAPS PharmSciTech. 2011 Dec;12(4):1264-75. doi: 10.1208/s12249-011-9684-0. Epub 2011 Sep 27.
Many pharmaceutical or biotechnological products require transport using temperature-controlled systems to keep their therapeutic properties. There are presently no official guidelines for testing pharmaceutical products in order to define suitable transport specifications. After reviewing the current guidance documents, this paper proposes a methodology for testing pharmaceutical products and defining appropriate transport conditions.
许多医药或生物技术产品需要使用控温系统运输,以保持其治疗特性。目前尚无针对医药产品的测试的官方指南,以确定合适的运输规范。在审查了现行的指导文件后,本文提出了一种测试医药产品和确定适当运输条件的方法。