Guidelines on stability evaluation of vaccines

Biologicals

Volumn 37, Issue 6, 2009, Pages 424-434

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN; VACCINE;

AGE; ARTICLE; CALCULATION; DATA ANALYSIS; DRUG APPROVAL; DRUG FORMULATION; DRUG LABELING; DRUG RELEASE; DRUG SCREENING; DRUG STABILITY; DRUG USE; EXPIRATION DATE; FREEZE DRYING; LICENSING; MATERIALS HANDLING; PRACTICE GUIDELINE; PRIORITY JOURNAL; SAMPLING; STATISTICAL CONCEPTS; STUDY DESIGN; THERMOSTABILITY; VACCINE PRESENTATION; VACCINE PRODUCTION; CHEMISTRY; DRUG STORAGE; HUMAN; METHODOLOGY; STANDARD;

CHEMISTRY, PHARMACEUTICAL; DRUG EVALUATION; DRUG STABILITY; DRUG STORAGE; HUMANS; VACCINES;

EID: 77449158532     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2009.08.017     Document Type: Article

References (11)

1. Guidelines for clinical evaluation of vaccines: regulatory expectations. WHO Expert Committee on biological standardization. Fifty-second report, 2004, World Health Organization, Geneva Annex 1 [WHO Technical Report Series No. 924].
2. Guidelines for nonclinical evaluation of vaccines. In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization [WHO Technical Report Series, No. 927].
3. World Health Organization, Expert Committee on Specifications for Pharmaceutical Preparations, 34th Report, Technical Report Series No 863, Annex 5; 1996.
4. International conference on harmonization, guidelines, topic Q5C quality of biotechnological products: stability testing of biotechnological/biological products. www.ich.org, 1996.
5. International conference on harmonization, guidelines, topic Q1A (R2) stability testing of new drug substances and products; 2003.
6. International conference on harmonization, guidelines, topic Q1B photostability testing of new active substances and medicinal products; 1998.
7. International conference on harmonization, guidelines, topic Q1E Evaluation of stability data; 2003.
8. International conference on harmonization, guidelines, topic Q1D bracketing & matrixing designs for stability testing of new drug substances and drug products; 2002.
9. Concept paper on the development of a Committee for proprietary medicinal products (CPMP) points to consider on stability and traceability requirements for vaccine intermediates – CPMP/BWP/4310/00; 2001.
10. Recommendations for the preparation, characterization and establishment of international and other biological reference materials. In: WHO Expert Committee on biological standardization, Fifty-fifth report. Geneva, World Health Organization, WHO Technical Report Series, in press.
11. Temperature sensitivity of vaccines. 2006, WHO Department of Immunization, Vaccines and Biologicals.