Bridging studies in clinical development

Journal of Biopharmaceutical Statistics

Volumn 12, Issue 3, 2002, Pages 359-367

  Liu, Jen Pei ^a   Chow, Shein Chung ^b  

^a NATIONAL CHENG KUNG UNIVERSITY   (Taiwan)

^b StatPlus Inc   (United States)

Author keywords

Bridging studies; Ethnic factors; Extrapolation; Similarity

Indexed keywords

DRUG;

ARTICLE; BAYES THEOREM; CLINICAL STUDY; DATA ANALYSIS; DOSE RESPONSE; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG MANUFACTURE; DRUG SAFETY; ETHNIC DIFFERENCE; FOOD AND DRUG ADMINISTRATION; GEOGRAPHY; PHARMACEUTICS; POPULATION RESEARCH; PRACTICE GUIDELINE; PRIORITY JOURNAL; REGULATORY MECHANISM; STATISTICAL ANALYSIS; STATISTICAL MODEL;

ALGORITHMS; BAYES THEOREM; CLINICAL TRIALS; DRUG INDUSTRY; DRUG THERAPY; ETHNIC GROUPS; GUIDELINES; MODELS, STATISTICAL; PHARMACEUTICAL PREPARATIONS; POPULATION; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN;

EID: 0036431676     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120014564     Document Type: Article

References (9)

1. ICH. International conference on harmonization tripartite guidance E5. Ethnic Factors in the Acceptability of Foreign Data, The U.S. Federal Register, 1998; Vol. 83, 31790-31796.
2. Shao, J.; Chow, S.C. Reproducibility probability in clinical trial. Stat. Med. 2002, 21, 1727-1742.
3. Chow, S.C.; Shao, J.; Hu, O.Y.P. Assessing sensitivity and similarity in bridging studies. J. Biopharm. Stat. 2002, 12 (3), 385-400.
4. FDA. Guidance for Industry on Statistical Approaches to Establishing Bioequivalence; Center for Drug Evaluation and Research, Food and Drug Administration: Rockville, MD, 2001.
5. Shih, W.J. Clinical trials for drug registrations in Asian-Pacific countries: Proposal for a new paradigm from a statistical perspective. Control. Clin. Trials 2001, 22, 357-366.
6. Liu, J.P.; Hsueh, H.-M.; Chen, J.J. Sample size requirement for evaluation of bridging evidence. Biometrical J. 2002, accepted.
7. Liu, J.P.; Hsueh, H.-M.; Hsiao, C.F. Bayesian approach to evaluation of the bridging studies. J. Biopharm. Stat. 2002, 12 (3), 401-408.
8. Hung, H.M.J.; O'Neill, R.T.; Bauer, P.; Kohne, K. The behavior of the P-value when alternative hypothesis is true. Biometrics 1997, 53, 11-22.
9. Chow, S.C.; Shao, J. Statistics in Drug Research - Methodologies and Recent Development; Marcel Dekker, Inc.: New York, 2002.