Equivalence studies for complex active ingredients and dosage forms

Author:

Bhattycharyya Lokesh,Dabbah Roger,Hauck Walter,Sheinin Eric,Yeoman Lynn,Williams Roger

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference28 articles.

1. USP. About USP—an overview. Available at: www.usp.org/aboutUSP/.Accessed October 10, 2005.

2. Board of Trustees, United States Pharmacopeial Convention.United States Pharmacopeial Convention Quinquennial Meeting 2000 Proceedings. Rockville, Maryland: United States Pharmacopeial Convention; 2000:400.

3. USP. Biological and Biotechnological Drug Substances and Products Workbook; November 18–21, 2003; Crystal City, VA. 2003.

4. World Health Organization.Consultation on International Biological Standards for In Vitro Diagnostic Procedures, Blood Safety, and Clinical Technology. Geneva, Switzerland: World Health Organization; 2000.

5. Federal Food, Drug, and Cosmetics Act, 21USC § 321(g).

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