AAPS PharmSciTech

, Volume 12, Issue 4, pp 1264–1275 | Cite as

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

Review Article


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.

Key words

biotechnological products distribution pharmaceutical products stability temperature excursions transport 



The author would like to acknowledge Dr. Manuel Zahn, Managing Director, 3R Pharma Consulting GmbH, Dr Steve Butcher and Dr Eugene Helsel, Senior Director, Quality, Stemedica Cell Technologies, Inc., San Diego, CA, for reviewing the article and their very appreciated and friendly support.


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Copyright information

© American Association of Pharmaceutical Scientists 2011

Authors and Affiliations

  1. 1.Claude Ammann ConsultingEpalingesSwitzerland

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