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来自世界著名药厂百特和阿斯利康，康涅狄格大学，慕尼黑大学的8名欧美冻干技术专家共同署名在2017年Journal of Pharmaceutical Sciences发表专题评论“Lyophilized Drug Product Cake Appearance: What Is Acceptable? 冻干制剂外观什么样子是可以接受的？” 对于冻干制剂外观的标准进行了深入讨论，质疑流行于业界的冻干注射剂外表要“均匀美观”的潜规则。 现将原文和摘要译文提供如下，供同仁参考。日后将其中的图片和中文说明陆续提供给大家。 Abstract 摘要 Cake appearance is an important attribute of freeze-dried-products, which may or may not be critical with respect to product quality (i.e., safety and efficacy). Striving for “uniform and elegant” cake appearance may continue to remain an important goal during the design and development of a lyophilized drug product. However, “sometimes” a non-idealcake appearance has no impact on product quality and is an inherent characteristic of the product (due to formulation, drug product presentation, and freezedrying process). This commentary provides a summary of challenges related to visual appearance testing of freeze-dried products, particularly on how to judge the criticality of cake appearance. Furthermore, a harmonized nomenclature and description for variations in cake appearance from the ideal expectation of uniform and elegant is provided, including representative images. Finally, a science and risk-based approach is discussed on establishing acceptance criteria for cake appearance. 冻干注射剂的外观是一项重要的指标。从产品质量角度而言（安全性和有效性）它可能是也可能不是关键指标。虽然“均匀优雅”的外观是冻干注射剂设计和研发追求的目标，但是，某些情况下，产品外观不雅只是产品内在的特性（与配方，剂型和冻干过程相关）并不影响产品质量。本评论针对冻干制剂灯检所遇到的问题，特别是如何判别制品外观合格与否做一汇总。另外，对于那些非“均匀优雅”外观的描述和统一所用的术语提供提供了定义和图片。最后，基于科学和风险评估方式。对制品外观可以接受的准则进行了探讨。 | 
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发表于 2018-2-26 15:57:44
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