By C. Ammann
Published in: AAPS PharmSciTech. 2011 Dec;12(4):1264-75. doi: 10.1208/s12249-011-9684-0. Epub 2011 Sep 27
Published on: September 27, 2011
Abstract: 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.