Comparison of bracketing and matrixing designs for a two-year stability study

Journal of Biopharmaceutical Statistics

Volumn 10, Issue 2, 2000, Pages 217-228

  Pong, Annpey ^a   Raghavarao, Damaraju ^b  

^a BAYER PHARMA AG   (Germany)

^b TEMPLE UNIVERSITY   (United States)

Author keywords

Bracketing design; Degradation; Expiration dating period; Matrixing design; Shelf life; Stability study

Indexed keywords

NEW DRUG;

DRUG DEGRADATION; DRUG INDUSTRY; DRUG RESEARCH; DRUG STABILITY; FOOD AND DRUG ADMINISTRATION; MATHEMATICAL ANALYSIS; PRIORITY JOURNAL; REVIEW; STATISTICAL MODEL;

ALGORITHMS; COMPUTER SIMULATION; DRUG STABILITY; MODELS, STATISTICAL; RESEARCH DESIGN;

EID: 0033819066     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-100101023     Document Type: Review

References (8)

1. Statistical design and analysis of stability studies
2. New design for stability testing programs: Matrix or factorial designs authorities' viewpoint on the predictive value of such studies
3. Expiration dating of pharmaceutical compounds in relation to analytical variation, degradation rate, and matrix designs
4. Some optimal matrix designs in stability studies
5. Statistical comparison of stability drug designs