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

Author:Claude Ammann

AAPS PharmSciTechVol. 12 Number 4, Dec 2011
DOI: 10.1208/s12249-011-9684-0,  Pages: 1264-1275

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
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