Equivalence studies for complex active ingredients and dosage forms
| Autor: | Eric Sheinin, Roger L. Williams, Lynn C. Yeoman, Lokesh Bhattycharyya, Roger Dabbah, Walter W. Hauck |
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| Rok vydání: | 2005 |
| Předmět: |
Therapeutic equivalency
Chemistry Pharmaceutical Pharmacology toxicology Pharmaceutical Science Article law.invention law Pharmacopoeias as Topic Humans Medicine Formulary Equivalence (measure theory) Dosage Forms Active ingredient business.industry Reference Standards United States Biotechnology Pharmaceutical Preparations Therapeutic Equivalency CLARITY Engineering ethics Regulatory agency business |
| Zdroj: | The AAPS Journal. 7:E786-E812 |
| ISSN: | 1550-7416 |
| DOI: | 10.1208/aapsj070477 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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