SCOPUS 정보 검색 플랫폼

Biologicals

Volumn 37, Issue 6, 2009, Pages 369-378

Goals of stability evaluation throughout the vaccine life cycle

(1) Krause, Philip R a

a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (United States)

Author keywords

Development; Licensure; Manufacturing changes; Monitoring; Potency

Indexed keywords

VACCINE;

ARTICLE; DRUG APPROVAL; DRUG DETERMINATION; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG MANUFACTURE; DRUG METABOLISM; DRUG MONITORING; DRUG POTENCY; DRUG QUALITY; DRUG SAFETY; DRUG STABILITY; HUMAN; MATHEMATICAL MODEL; PRACTICE GUIDELINE; PREDICTION; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; QUALITY CONTROL; SHELF LIFE; VACCINE PRODUCTION;

CHEMISTRY, PHARMACEUTICAL; DRUG DESIGN; DRUG EVALUATION; DRUG STABILITY; DRUG STORAGE; HUMANS; QUALITY CONTROL; VACCINES;

EID: 70449533155 PISSN: 10451056 EISSN: 10958320 Source Type: Journal
DOI: 10.1016/j.biologicals.2009.08.015 Document Type: Article

Times cited : (12)

References (9)

1
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2
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- Krause, P.¹ Klinman, D.²

3
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- International Conference on Harmonization. Validation of analytical procedures: text and methodology Q2(R1); 2005. http://www.ich.org/LOB/media/MEDIA417.pdf.
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4
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- International Conference on Harmonization. Q1A(R2): stability testing of new drug substances and products (second revision); 2003a. http://www.ich.org/LOB/media/MEDIA419.pdf.
- International Conference on Harmonization. Q1A(R2): stability testing of new drug substances and products (second revision); 2003a. http://www.ich.org/LOB/media/MEDIA419.pdf.

5
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- International Conference on Harmonization. Q1E: evaluation for stability data; 2003b. http://www.ich.org/LOB/media/MEDIA415.pdf.
- (2003) International Conference on Harmonization. Q1E: Evaluation for stability data

6
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- Determination of release limits: a general methodology
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- Allen, P.¹ Dukes, G.² Gerger, M.³

7
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- Stability of further-attenuated measles vaccines
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8
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- World Health Organization. Guidelines on stability evaluation of vaccines (adopted by the 57th meeting of the WHO ECBS, 23-27 Oct 2006); 2006. http://www.who.int/biologicals/publications/trs/areas/vaccines/stability /Microsoft%20Word%20-%20BS%202049.Stability.final.09_Nov_06.pdf.
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9
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- Monitoring the stability of human vaccines
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.