A practical approach for evaluating population and individual bioequivalence

Statistics in Medicine

Volumn 19, Issue 20, 2000, Pages 2721-2740

  Gould, A Lawrence ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DIURETIC AGENT; FUROSEMIDE;

ARTICLE; BIOEQUIVALENCE; BIOSTATISTICS; CLINICAL RESEARCH; CLINICAL TRIAL; CROSSOVER PROCEDURE; DIURETIC THERAPY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; HUMAN; POPULATION RESEARCH; STATISTICAL MODEL;

AREA UNDER CURVE; HUMAN; MODELS, STATISTICAL; RESEARCH DESIGN; THERAPEUTIC EQUIVALENCY;

EID: 0034735587     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/1097-0258(20001030)19:20<2721::AID-SIM541>3.0.CO;2-8     Document Type: Article

References (58)

1. Bioequivalence and interchangeability
2. A new procedure for testing equivalence in comparative bioavailability and other clinical trials
3. Consideration of individual bioequivalence
4. Towards a practical strategy for assessing individual bioequivalence. Food and Drug Administration Individual Bioequivalence Working Group
5. In the blood: Proposed new requirements for registering generic drugs
6. Types of bioequivalence and related statistical considerations
7. The subject-by-formulation interaction as a criterion of interchangeability of drugs
8. Bioequivalence revisited
9. Variance-components in comparative bioavailability studies
10. On population and individual bioequivalence
11. Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar
12. Individual bioequivalence: A regulatory update
13. Mean difference vs. variability reduction: Tradeoffs in aggregate measures for individual bioequivalence
14. Food and Drug Administration Guidance for Industry: In vivo bioequivalence studies based on population and individual bioequivalence approaches
15. A comment on so-called individual criteria of bioequivalence
16. Discussion of individual bioequivalence by M.-L. Chen
17. Some issues for the consideration of individual bioequivalence
18. Some thoughts on individual bioequivalence
19. Moment-based criteria for determining bioequivalence
20. Subject-by-formulation interaction in determinations of individual bioequivalence: Bias and prevalence
21. Asymmetry of the mean-variability tradeoff raises questions about the model in investigations of individual bioequivalence
22. Effects of uncertainties of the estimated variances on the evaluation of individual bioequivalence
23. Asymmetry of the mean-variability tradeoff raises questions about the model in investigations of individual bioequivalence
24. A small sample confidence interval approach to assess individual bioequivalence
25. Comparative bioavailability of a generic phenytoin and Dilantin Epilepsia
26. Knowledge of and attitudes about adverse drug reaction reporting among Rhode Island pharmacists
27. Generic drug substitution revisited
28. Interchangeability of low-dose oral contraceptives. Are current bioequivalent testing measures adequate to ensure therapeutic equivalency?
29. Prednisolone concentrations in cerebrospinal fluid after different prednisolone prodrugs
30. Loss of seizure control associated with generic substitution of carbamazepine
31. Carbamazepine toxicity resulting from generic substitution
32. Bioequivalence (bioavailability) of generic topical corticosteroids
33. Generic substitution of antiarrhythmic drugs
34. Treatment failure after substitution of generic pancrelipase capsules. Correlation with in vitro lipase activity
35. Therapeutic equivalence of a generic slow-release theophylline tablet
36. Generic and alternative brand-name pharmaceutical equivalents: Select with caution
37. Therapeutic inequivalence
38. Generic inhaled salbutamol versus branded salbutamol. A randomised double-blind study
39. On the assessment of variability in bioavailability/bioequivalence studies
40. Exact inference about the within-subject variability in 2 x 2 crossover trials
41. A three-step procedure for assessing bioequivalence in the general mixed model framework
42. A simple three-step procedure for parametric and nonparametric assessment of bioequivalence
43. On closed testing procedures with special reference to ordered analysis of variance
44. On a test for an assigned value of correlation in a bivariate normal distribution
45. On the distribution of r in samples from the mixtures of bivariate normal populations
46. 2 distribution
47. A concordance coefficient to evaluate reproducibility
48. Common canonical variates in k independent groups
49. 1993 Conference report
50. Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics
51. Evaluation of orally administered highly variable drags and drug formulations
52. Bioequivalence studies: Single vs multiple dose
53. Conditional means and covariances of normal variables with singular covariance matrix