Bridging bioequivalence studies

Journal of Biopharmaceutical Statistics

Volumn 14, Issue 4, 2004, Pages 857-867

  Liu, Jen Pei ^a  

^a NATIONAL TAIWAN UNIVERSITY   (Taiwan)

Author keywords

Average bioequivalence; Bridging bioequivalence study; Bridging reference formulation; Sample size

Indexed keywords

GENERIC DRUG; NEW DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CALCULATION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SCREENING; MATHEMATICAL ANALYSIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REFERENCE VALUE; REVIEW; SAMPLE SIZE;

ALGORITHMS; CHEMISTRY, PHARMACEUTICAL; CROSS-OVER STUDIES; DATA INTERPRETATION, STATISTICAL; RESEARCH DESIGN; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY;

AUDIO-VISUAL FEATURES ANALYSIS; CAPTION RECOGNITION; CONTENT-BASED VIDEO BROWSING AND RETRIEVAL; NEWS STORY SEGMENTATION;

ALGORITHMS; AUDIO SYSTEMS; CAMERAS; IMAGE ANALYSIS; INFORMATION RETRIEVAL; SEMANTICS; VIDEOCASSETTE RECORDERS;

WEB BROWSERS;

EID: 9744281265     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-200035418     Document Type: Review

References (11)

1. Chow, S. C., Liu, J. P. (1997). Meta-analysis for bioequivalence review. J. Biopharmaceut. Statist. 7:97-111.
2. Chow, S. C., Liu, J. P. (2000). Design and Analysis of Bioavailability and Bioequivalence. 2nd ed. Revised and Expanded. New York: Marcel Dekker, Inc.
3. Cochran, W. G., Cox, G. M. (1950). Experimental Design. New York: Wiley.
4. Fleming, T. R. (2000). Design and interpretation of equivalence trials. Am. Heart J. 139:S172-S176.
5. ICH E5. (1998). Ethnic Factors in the Acceptability of Foreign Data. In: International Conference on Harmonization Tripartite Guidance E5. The U.S. Federal_Register, Vol. 83, pp. 31,790-31,796.
6. Liu, J. P., Hsueh, M. M., Chen, J. J. (2002a). Sample size requirements for evaluation of bridging evidence. Biometric. J. 44:969-981.
7. Liu, J. P., Hsiao, C. F., Hsueh, H. M. (2002b). Bayesian approach to evaluation of bridging studies. J. Biopharmaceut. Stat. 12:287-294.
8. Rothmann, M., Li, N., Chen, G., Chi, G. Y. H., Temple, R., Tsou, H. H. (2003). Design and analysis of non-inferiority mortality trials in oncology. Statist. Med. 22:239-264.
9. The US FDA (2003). Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug products General Considerations. Rockville, Maryland: The U.S. Food and Drug Administration.
10. Wang, S. J., Hung, J. H. M., Tsong, Y. (2002). Utility and pitfalls of some statistical methods in active control trials. Control. Clin. Trials 23:15-28.
11. Wang, S. J., Hung, J. H. M. (2003). TACT method for noninferiority testing in active controlled trials. Statist. Med. 22:227-238.