Some considerations about stability study design

Journal of Biopharmaceutical Statistics

Volumn 10, Issue 1, 2000, Pages 73-82

  Repeto, Paolo ^a  

^a GSK   (Italy)

Author keywords

Consumer loss; Producer gain

Indexed keywords

ARTICLE; DRUG STABILITY; METHODOLOGY; PREDICTION; PRIORITY JOURNAL; SHELF LIFE; STATISTICAL ANALYSIS;

DRUG STABILITY; HUMANS; MODELS, STATISTICAL; RESEARCH DESIGN;

EID: 0034000502     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-100101014     Document Type: Article

References (3)

1. Wei GCG: "Simple Methods for Determination of the Release Limits for Drug Products," J. Biopharm. Stat., 8(1), 103-114, 1998.
2. Triman K, Lyons R, Coleman M: "An Alternative Approach to the Assignment of Expiration Dates for Drug Products," Drug Devel. Industrial Pharmacy, 12(12), 1429-1437, 1995.
3. Wessel P, Holz M, Erni F, Krummen K, Ogorka J: "Statistical Evaluation of Stability Data of Pharmaceutical Products for Specification Setting," Drug Devel. Industrial Pharmacy, 23(5), 427-439, 1997.