On a reasonable disaggregate criterion of population bioequivalence admitting of resampling-free testing procedures

Statistics in Medicine

Volumn 19, Issue 20, 2000, Pages 2755-2767

  Wellek, Stefan ^a  

^a CENTRAL INSTITUTE OF MENTAL HEALTH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOEQUIVALENCE; BIOSTATISTICS; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HUMAN; SAMPLING; STATISTICAL ANALYSIS;

AREA UNDER CURVE; HUMAN; MODELS, STATISTICAL; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0034735534     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/1097-0258(20001030)19:20<2755::AID-SIM543>3.0.CO;2-O     Document Type: Article

References (17)

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3. Individual bioequivalence - A regulatory update
4. On a heuristic method of test construction and its use in multivariate analysis
5. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
6. A note on normal correlation
7. A test for the significance of the difference between the two variances in a sample from a normal bivariate population
8. On assessment of variability in bioavailability/bioequivalence studies
9. Exact inference about the within-subject variability in 2 x 2 crossover trials
10. Bioequivalence Stuides-II. Gender studies with non-replicate designs
11. Optimal unbiased tests for equivalence in intrasubject variability
12. A new approach to equivalence assessment in standard comparative bioavailability trials by means of the Mann-Whitney statistic