PHARMACEUTICAL SOLIDS - A STRATEGIC APPROACH TO REGULATORY CONSIDERATIONS

被引：370

作者：

BYRN, S ^{[1
]}

PFEIFFER, R ^{[1
]}

GANEY, M ^{[1
]}

HOIBERG, C ^{[1
]}

POOCHIKIAN, G ^{[1
]}

机构：

[1] US FDA,DIV ONCOL & PULM,ROCKVILLE,MD 20857

来源：

PHARMACEUTICAL RESEARCH | 1995年 / 12卷 / 07期

关键词：

POLYMORPH; HYDRATE; AMORPHOUS FORM; DESOLVATED SOLVATE;

D O I：

10.1023/A:1016241927429

中图分类号：

O6 [化学];

学科分类号：

0703 ;

摘要：

This review describes a conceptual approach to the characterization of pharmaceutical solids. Methods. Four flow charts are presented: (1) polymorphs, (2) hydrates, (3) desolvated solvates, and (4) amorphous forms. Results. These flow charts (decision trees) are suggested as tools to develop information on pharmaceutical solids for both scientific and regulatory purposes. Conclusions. It is hoped that this review will lead to a more direct approach to the characterization of pharmaceutical solids and ultimately to faster approval of regulatory documents containing information on pharmaceutical solids.

引用

页码：945 / 954

页数：10

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