Stability Evaluation of National Reference Standards for Blood Products in Korea-Reference-Cited by-同舟云学术

Stability Evaluation of National Reference Standards for Blood Products in Korea

Published:2017-07-15 Issue:3 Volume:33 Page:225-231
ISSN:1976-8257
Container-title:Toxicological Research
language:en
Short-container-title:ToxicolRes

Author:

Park Tae Jun¹,Choi Chan Woong¹,Oh Ho Kyung²,Kim Jae Ok¹,Kim Byung Kuk¹,Kang Hyun Kyung¹,Kwon Eun Jeong¹,Gweon Eun Jeong¹,Park Sang Jin¹,Kang Ho Il²,Jung Ki Kyung²,Park Sang Mi²,Kim Ji Hye²,Han Ki Won²,Jeong Ja Young¹

Affiliation:

1. Biologics Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea

2. Blood Products Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea

Funder

Ministry of Food and Drug Safety(MFDS)

Publisher

The Korean Society of Toxicology

Subject

Health, Toxicology and Mutagenesis,Toxicology

Link

http://pdf.medrang.co.kr/TR/2017/033/TR033-03-07.pdf

Reference12 articles.

1. Stability evaluation of vaccines: WHO approach

2. World Health Organization (2011). WHO manual for the establishment of national and other secondary standards of vaccines (Ordering code: WHO/IVB/11.03). Geneva: WHO

3. World Health Organization (1992). Annex 2: Guidelines for national authorities on quality assurance for biological products: WHO

4. ICH (2003). Stability testing of new drug substances and products, Q1A(R2), step 4: ICH

5. Best practices in regulation of blood and blood products

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