Maintenance of vaccine stability through annual stability and comparability studies

Biologicals

Volumn 37, Issue 6, 2009, Pages 397-402

  Schofield, Timothy L ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Accelerated stability; Annual stability; Equivalence study; Stability comparison

Indexed keywords

VACCINE;

ARTICLE; BIOEQUIVALENCE; DRUG APPROVAL; DRUG DEGRADATION; DRUG INFORMATION; DRUG MANUFACTURE; DRUG MONITORING; DRUG POTENCY; DRUG QUALITY; DRUG RESEARCH; DRUG STABILITY; DRUG STORAGE; HUMAN; METHODOLOGY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; QUALITY CONTROL; SHELF LIFE; VACCINE PRODUCTION;

DRUG EVALUATION; DRUG STABILITY; DRUG STORAGE; HUMANS; QUALITY CONTROL; THERAPEUTIC EQUIVALENCY; TIME FACTORS; VACCINES;

EID: 70350714257     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2009.08.010     Document Type: Article

References (5)

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4. Guidance for Industry, Statistical approaches to establishing bioequivalence, U.S. Food and Drug Administration 2001.
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