Equivalence studies for complex active ingredients and dosage forms

被引：3

作者：

Bhattycharyya, L

Dabbah, R

Hauck, W

Sheinin, E

Yeoman, L

Williams, R

机构：

[1] US Pharmacopeia, Rockville, MD 20852 USA

[2] Thomas Jefferson Univ, Biostat Sect, Philadelphia, PA 19107 USA

[3] Baylor Coll Med, Houston, TX 77030 USA

来源：

AAPS JOURNAL | 2005年 / 7卷 / 04期

关键词：

US Pharmacopeia; biological or biotechnological drug; equivalence; generic biologics; complex active ingredient;

D O I：

10.1208/aapsj070477

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

This article examines the United States Pharmacopeia ( USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products-a role USP has played since its founding in 1820. A public monograph in the United States Pharmacopeia National Formulary helps practitioners and other interested parties understand how an article's strength, quality, and purity should be controlled. Such a monograph is a standard to which all manufactured ingredients and products should conform, and it is a starting point for subsequent-entry manufacturers, recognizing that substantial additional one-time characterization studies may be needed to document equivalence. Review of these studies is the province of the regulatory agency, but compendial tests can provide clarity and guidance in the process.

引用

页码：E786 / E812

页数：27