藥物安定性規範之研究分析   全文下載

Current Issues in Regulatory Requirements of Drug Stability

對於市場上的任何一種藥物，政府規定其包裝標籤上必須註明該藥物的有效期限（expiration dating period），藥物的有效期限不僅提供消費者對該藥物的信心且保證在該藥物有效期限內仍然保持該藥物應具有的良藥特性，諸如成份（identity），效力（strength），品質（quality）以及純度（purity）。一般而言，藥廠經由藥物安定性的測試研究來描述藥物退化曲線進而估計藥物的有效期限。在這篇文章中，我們對現行美國安定性規範及國際標準化規範做了深入的探討與評估。同時，我們也列舉了一些經由評估所引發在藥物安定性測試中，實驗設計與統計分析的一些未來問題的研究方向。

For every commercial drug product, it is essential to indicate the expiration date to provide the consumer with some assurance that the drug product will retain its identity, strength, quality, and purity throughout the expiry period. For the determination of an expiration dating period, it is necessary to conduct stability studies to assess the intrinsic degradation of the drug product. In this paper, we provide an overview of regulatory requirements for stability including stability guidelines issued by the United States Food and Drug Administration and those established by the International Conference on Harmonization. In addition, we address current statistical design and analysis issues that often occur during the conduct of stability studies.