Recent issues in stability study

Journal of Biopharmaceutical Statistics

Volumn 13, Issue 3, 2003, Pages

  Tsong, Yi ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSTATISTICS; DRUG MONITORING; DRUG STABILITY; EDITORIAL; PHARMACOEPIDEMIOLOGY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL;

EID: 0043136555     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120022758     Document Type: Editorial

References (5)

1. Bancroft, T. A. (1944). On biases in estimation due to the use of preliminary tests of significance. Annal. Math. Stat. 15:190-204.
2. FDA. (1987). Guidelines for Submitting Documentation for the Stability of Human Drugs and Biologics. Rockville, MD: USA Food and Drug Administration, Center for Drugs and Biologics.
3. ICH. (1994). Q1A(R) Stability Testing of New Drug Substances and Products. Geneva, Switzerland: Conference on Harmonization. (http://www.fda.gov/cder/guidance/index.htm).
4. ICH. (2003a). Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. Geneva, Switzerland: Conference on Harmonization. (http://www.fda.gov/cder/guidance/index.htm).
5. ICH. (2003b). Q1E Stability Data Evaluation. Geneva, Switzerland: Conference on Harmonization. (http://www.fda.gov/cder/guidance/index.htm).