Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods-Reference-Cited by-同舟云学术

Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods

Published:2012-08-15 Issue:12 Volume:29 Page:3404-3419
ISSN:0724-8741
Container-title:Pharmaceutical Research
language:en
Short-container-title:Pharm Res

Author:

Apostol Izydor,Kelner Drew,Jiang Xinzhao Grace,Huang Gang,Wypych Jette,Zhang Xin,Gastwirt Jessica,Chen Kenneth,Fodor Szilan,Hapuarachchi Suminda,Meriage Dave,Ye Frank,Poppe Leszek,Szpankowski Wojciech

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Link

http://www.springerlink.com/index/pdf/10.1007/s11095-012-0836-z

Reference58 articles.

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2. Kemsley JN. Analyzing protein drugs. Chem Eng News. 2009;87:20–3.

3. CDER. Guidance for industry Bioanlaytical method validation. Guidance for industry: Bioanlaytical method validation, 2001.

4. USP. Chromatography Section. United States Pharmacopeia Convention, US Pharmacopeia Rockville, MD; 1994, p. 1776.

5. USP. Validation of Compendial Methods. US Pharmacopeia, Rockville, MD; 1999, p. 2149.

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