title: Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products.
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.
authors.affiliation: Claude Ammann Consulting, Epalinges, Switzerland. info@claudeammann.com
authors.forename: Claude
authors.initials: C
authors.lastname: Ammann
mesh_terms: D001685:Biological Factors / Q000737:chemistry* / Q000592:standards; D001709:Biotechnology / Q000379:methods* / Q000592:standards; D004355:Drug Stability; D017408:Guidelines as Topic; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D013696:Temperature; D013997:Time Factors; D014186:Transportation / Q000592:standards
chemical_list: D001685:Biological Factors; D004364:Pharmaceutical Preparations