Vaccine stability study design and analysis to support product licensure

Biologicals

Volumn 37, Issue 6, 2009, Pages 387-396

  Schofield, Timothy L ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Accelerated stability; Bulk stability; Long term stability; Release potency; Shelf life

Indexed keywords

MEASLES VACCINE; VACCINE;

ARTICLE; DRUG APPROVAL; DRUG DEGRADATION; DRUG INFORMATION; DRUG LABELING; DRUG MANUFACTURE; DRUG PACKAGING; DRUG POTENCY; DRUG QUALITY; DRUG RESEARCH; DRUG STABILITY; DRUG STORAGE; HUMAN; METHODOLOGY; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; SHELF LIFE; STATISTICAL ANALYSIS; STATISTICAL MODEL; VACCINE PRODUCTION;

CHEMISTRY, PHARMACEUTICAL; DATA INTERPRETATION, STATISTICAL; DRUG EVALUATION; DRUG STABILITY; HUMANS; LICENSURE, PHARMACY; MEASLES VACCINE; RESEARCH DESIGN; TIME FACTORS; VACCINES;

EID: 70350712151     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2009.08.009     Document Type: Article

References (3)

1. ICH Q1A(R2), Stability testing of new drug substances and products, current Step 4 version dated 6 February 2003 by the ICH Steering Committee.
2. ICH Q1E, Evaluation of stability data, current Step 4 version dated 6 February 2003 by the ICH Steering Committee.
3. Allen P.V., Dukes G.R., and Gerger M.E. Determination of release limits: a general methodology. Pharmaceutical Research 8 9 (1993) 1210-1213