The application of the accelerated stability assessment program (ASAP) to quality by design (QbD) for drug product stability

AAPS PharmSciTech

Volumn 12, Issue 3, 2011, Pages 932-937

  Waterman, Kenneth Craig ^a  

^a PFIZER INC   (United States)

Author keywords

accelerated aging; QbD; shelf life; stability

Indexed keywords

ACCELERATED STABILITY ASSESSMENT PROGRAM; CHEMICAL REACTION; CONFIDENCE INTERVAL; COST; DEGRADATION; DRUG SURVEILLANCE PROGRAM; HUMIDITY; ISOTHERM; PRIORITY JOURNAL; PRODUCT PARAMETERS; REVIEW; SHELF LIFE; TEMPERATURE;

DOSAGE FORMS; DRUG PACKAGING; DRUG STABILITY; DRUG STORAGE; EXCIPIENTS; HUMIDITY; KINETICS; MODELS, CHEMICAL; PROGRAM EVALUATION; RESEARCH DESIGN; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE;

EID: 80052581773     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-011-9657-3     Document Type: Review

References (15)

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