Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products

需要进行稳定性研究,以确定敏感药品或生物技术产品的处理和运输条件。

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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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