Some conceptual issues in the evaluation of average, population, and individual bioequivalence

Drug Information Journal

Volumn 35, Issue 3, 2001, Pages 893-899

  Steinijans, V W ^a  

^a ALTANA PHARMA AG   (Germany)

Author keywords

Average bioequivalence; Bioequivalence; Individual bioequivalence; Population bioequivalence

Indexed keywords

BIOEQUIVALENCE; CONFERENCE PAPER; DRUG FORMULATION; EVALUATION; POPULATION; PRIORITY JOURNAL; STATISTICAL MODEL;

EID: 0034840462     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150103500328     Document Type: Conference Paper

References (26)

1. Towards a practical strategy for assessing individual bioequivalence
2. Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics
3. Individual and average bioequivalence of highly variable drugs and drug products
4. PhRMA perspective on population and individual bioequivalence
5. An individual bioequivalence criterion: Regulatory considerations
6. Some statistical considerations on the FDA draft guidance for individual bioequivalence
7. Subject-by-formulation interaction in determinations of individual bioequivalence: Bias and prevalence
8. Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence
9. The U.S. draft guidance regarding population and individual bioequivalence approaches: Comments by a research-based pharmaceutical company
10. Note for guidance: Investigation of bioavailability and bioequivalence
11. A comparison of the two one-sided tests procedure and the power approach for assessing the average bioavailability
12. A distribution-free procedure for the statistical analysis of bioequivalence studies
13. On population and individual bioequivalence
14. A small sample confidence interval approach to assess individual bioequivalence
15. Application of single-dose vs. multiple-dose studies
16. Exact comparisons of means and within-subject variances in 2 × 2 crossover trials
17. A practical approach for evaluating population and individual bioequivalence
18. On a reasonable disaggregate criterion of population bioequivalence admitting of resamplingfree testing procedures
19. A simple three-step procedure for parametric and nonparametric assessment of bioequivalence
20. Individual bioequivalence - A review of the FDA draft guidance
21. Mean difference vs. variability reduction: Tradeoffs in aggregate measures for individual bioequivalence