A note on kinetic modeling of stability data and implications on pooling

Journal of Biopharmaceutical Statistics

Volumn 13, Issue 3, 2003, Pages 425-430

  Altan, Stan ^a   Raghavarao, Damaraju ^b  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b TEMPLE UNIVERSITY   (United States)

Author keywords

Expiration date; Kinetic modeling; Shelf life; Stability modeling

Indexed keywords

ARTICLE; DATA ANALYSIS; DRUG DEGRADATION; DRUG LABELING; DRUG POTENCY; DRUG STABILITY; EXPIRATION DATE; KINETICS; PRIORITY JOURNAL; SHELF LIFE; STATISTICAL MODEL;

DRUG STABILITY; DRUG STORAGE; KINETICS; MODELS, STATISTICAL; TIME FACTORS;

EID: 0041633672     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120022764     Document Type: Article

References (7)

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3. DeWoody, K. L., Altan, S. (2001). Matrix designs in stability studies. In: Altan, S., Singh, J., eds. Recent Advances in Experimental Designs and Related Topics. New York: Nova, pp. 87-94.
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5. FDA. (1987). Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics. Rockville MD: Center for Drugs and Biologics, Office of Drug Research and Review, Food and Drug Administration.
6. FDA. (1998). Guidance for industry on stability testing of drug substances and drug products. Fed. Reg. 63(109):31224-31225.
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