Stability Studies Needed to Define Transport Conditions of Sensitive Products

Claude Ammann – May 1, 2012

Stability Studies Needed to Define the Handling and Transport Conditions of Sensitive Pharmaceutical or Biotechnological Products


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.

Claude Ammann, AAPS PharmSciTech Vol 12, No. 4, December 2011