藥品安定性研究綜論   全文下載

An Overview of Stability Studies

一般而言，各國政府藥品管理單位在廠商將藥品推出市面之前，均要求其實行安定性試驗以保証此藥品有優良藥品所應有之特性，如成份，效力，品質及純度。藥品安定性試驗的主要目的在於刻劃藥品之退化曲線，且估計其有效期限。本文回顧了安定性試驗的歷史，其中包括了對各國安定性試驗基準之比較及安定性試驗種類之概述。同時，我們亦略述了近年來的發展成果，且建議未來的研究方向。

Before any drug products are marketed, it is required by the government regulatory agencies that stability studies to be conducted. The objective of the stability studies is not only to characterize the degradation curve but also to estimate the shelf-life of the drug products. The estimated shelf-life gives a certain assurance that the drug products retains its identity, strength, quality and purity during the time period. In this paper, we give an overview of the stability studies, which includes the historical background, comparisons of guidelines among various countries, recent developments, as well as future research topics.