Assessing bioequivalence using genomic data

Journal of Biopharmaceutical Statistics

Volumn 14, Issue 4, 2004, Pages 869-880

  Chow, Shein Chung ^a   Shao, Jun ^b   Li, Li ^c  

^a NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

^b University of Wisconsin   (United States)

^c BRISTOL MYERS SQUIBB   (United States)

Author keywords

Average bioequivalence; Genomic data; Individual bioequivalence; Population bioequivalence; Sensitivity analysis

Indexed keywords

GENERIC DRUG;

BIOEQUIVALENCE; DATA ANALYSIS; DNA SEQUENCE; DRUG ABSORPTION; DRUG APPROVAL; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; GENE LOCATION; GENETIC LINKAGE; GENETIC MARKER; GENOMICS; PREDICTION; PRIORITY JOURNAL; QUANTITATIVE TRAIT LOCUS; REVIEW; RNA TRANSCRIPTION;

ACYCLOVIR; ALGORITHMS; ANTIVIRAL AGENTS; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DATA INTERPRETATION, STATISTICAL; GENOMICS; MODELS, STATISTICAL; PHARMACOKINETICS; POPULATION; THERAPEUTIC EQUIVALENCY; VALINE;

EID: 9244263007     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-200035420     Document Type: Review

References (8)

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3. Chow, S. C., Shao, J. (2002). Statistics in Drug Research-Methodologies and Recent Developments. New York: Marcel Dekker.
4. FDA (2001). Guidance for Industry-Statist. Approaches to Establishing Bioequivalence. Rockville: MD: Center for Drug Evaluation and Research, Food and Drug Administration.
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7. Landowski, C. P., Sun, D., Foster, D. R., Menon, S. S., Barnett, J. L., Welage, L. S., Ramachandran, C., Amidon, G. L. (2003). Gene expression in the human intestine and correlation with oral valacyclovir pharmacokinetic parameters. J. Pharmacol. Exp. Ther. 306:778-786.
8. Lee, Y., Shao, J., Chow, S. C. (2004). The modified large sample confidence intervals for linear combinations of variance components: Extension, theory, and application. J Am. Statist. Assoc. 99:467-478.