Drug shelf-life estimation

Statistica Sinica

Volumn 11, Issue 3, 2001, Pages 737-745

  Shao, Jun ^a   Chow, Shein Chung ^b  

^a University of Wisconsin Madison   (United States)

^b StatPlus Inc   (United States)

Author keywords

Asymptotic bias; Asymptotic mean squared error; Batch to batch variation; Inverse regression; Lower confidence bound; Lower prediction bound

Indexed keywords

EID: 0035633534     PISSN: 10170405     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (5)

1. Krutchkoff, R. G. (1967). Classical and inverse methods of calibration. Technometrics 9, 535-539.
2. FDA (1987). Guideline for submitting documentation for the stability of human drugs and biologizes. Rockville, Maryland: Food and Drug Administration, Center for Drug and Biologizes, Office of Drug Research and Review.
3. Halperin, M. (1970). On inverse estimation in linear regression. Technometrics 12, 727-736.
4. Shao, J. and Chen, L. (1997). Prediction bounds for random shelf-lives. Statist. Medicine 16, 1167-1173.
5. Shao, J. and Chow, S. (1994). Statistical inferences in stability analysis. Biometrics 50, 753-763.