Statistical issues on the FDA conjugated estrogen tablets bioequivalence guidance

Drug Information Journal

Volumn 30, Issue 4, 1996, Pages 881-889

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

^a NATIONAL CHENG KUNG UNIVERSITY   (Taiwan)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

Baseline; Carryover effect; Dissolution; Multiplicity; Study design

Indexed keywords

ESTROGEN;

BIOEQUIVALENCE; DRUG BIOAVAILABILITY; DRUG RELEASE; DRUG SOLUBILITY; ESTROGEN THERAPY; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; REVIEW; STATISTICS;

EID: 0029807472     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000403     Document Type: Review

References (10)

1. Guidance on Conjugated Estrogen Tablets - In Vivo Bioequivalence and In Vitro Drug Release. Rockville, MD: The Division of Bioequivalence, Office of Generic Drugs, the US Food and Drug Administration; August 1991.
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3. Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies. New York: Marcel Dekker, Inc.; 1992:253-288.
4. Liu JP. Use of the repeated crossover designs in assessing bioequivalence. Stat Med. 1995; 4:1067-1078.
5. Gill JL. Repeated measurements, split-plot trend analysis versus analysis of first difference. Biometrics. 1988;44:289-297.
6. Lindsey JK. Models for Repeated Measurements. Oxford, UK: Oxford Science Publications; 1993:73-136.
7. Tsong Y. Statistical assessment of mean differences between two dissolution data sets. Presented at the 1995 Drug Information Association Dissolution Workshop, Rockville, Maryland.
8. Chow SC, Ki FYC. Statistical comparison between dissolution profiles of drug products. J Biopharm Stat. 1996.
9. Chow SC, Liu JP. Statistical Design and Analysis in Pharmaceutical Sciences: Validation, Process Controls, and Stability. New York: Marcel Dekker, Inc.; 1995:151-197.
10. Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-up and Postapproval Changes. Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. Rockville, MD: Division of Bioequivalence, Office of Generic Drugs, Food and Drug Administration; November 1995.