182 related articles for article (PubMed ID: 12448572)
1. On statistical power for average bioequivalence testing under replicated crossover designs.
Wan H; Chow SC
J Biopharm Stat; 2002 Aug; 12(3):295-309. PubMed ID: 12448572
[TBL] [Abstract][Full Text] [Related]
2. Comparison of models for average bioequivalence in replicated crossover designs.
Willavize SA; Morgenthien EA
Pharm Stat; 2006; 5(3):201-11. PubMed ID: 17080753
[TBL] [Abstract][Full Text] [Related]
3. Testing for bioequivalence of highly variable drugs from TR-RT crossover designs with heterogeneous residual variances.
Kang Q; Vahl CI
Pharm Stat; 2017 Sep; 16(5):361-377. PubMed ID: 28620937
[TBL] [Abstract][Full Text] [Related]
4. Two-stage designs versus European scaled average designs in bioequivalence studies for highly variable drugs: Which to choose?
Molins E; Cobo E; Ocaña J
Stat Med; 2017 Dec; 36(30):4777-4788. PubMed ID: 28853164
[TBL] [Abstract][Full Text] [Related]
5. Assessment of average, population and individual bioequivalence in two- and four-period crossover studies.
Wijnand HP
Comput Methods Programs Biomed; 2003 Jan; 70(1):21-35. PubMed ID: 12468124
[TBL] [Abstract][Full Text] [Related]
6. A modified large sample approach in the assessment of population bioequivalence.
Quiroz J; Ting N; Wei GC; Burdick RK
J Biopharm Stat; 2000 Nov; 10(4):527-44. PubMed ID: 11104391
[TBL] [Abstract][Full Text] [Related]
7. Sample size determination for individual bioequivalence inference.
Chiang C; Hsiao CF; Liu JP
PLoS One; 2014; 9(10):e109746. PubMed ID: 25310592
[TBL] [Abstract][Full Text] [Related]
8. An individual bioequivalence criterion: regulatory considerations.
Chen ML; Patnaik R; Hauck WW; Schuirmann DJ; Hyslop T; Williams R
Stat Med; 2000 Oct; 19(20):2821-42. PubMed ID: 11033578
[TBL] [Abstract][Full Text] [Related]
9. Individual bioequivalence revisited.
Chen ML; Lesko LJ
Clin Pharmacokinet; 2001; 40(10):701-6. PubMed ID: 11707058
[TBL] [Abstract][Full Text] [Related]
10. Random-effects linear modeling and sample size tables for two special crossover designs of average bioequivalence studies: the four-period, two-sequence, two-formulation and six-period, three-sequence, three-formulation designs.
Diaz FJ; Berg MJ; Krebill R; Welty T; Gidal BE; Alloway R; Privitera M
Clin Pharmacokinet; 2013 Dec; 52(12):1033-43. PubMed ID: 24085600
[TBL] [Abstract][Full Text] [Related]
11. The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research-based pharmaceutical company.
Hauschke D; Steinijans VW
Stat Med; 2000 Oct; 19(20):2769-74. PubMed ID: 11033574
[TBL] [Abstract][Full Text] [Related]
12. Some statistical considerations on the FDA draft guidance for individual bioequivalence.
Hsuan FC
Stat Med; 2000 Oct; 19(20):2879-84. PubMed ID: 11033582
[TBL] [Abstract][Full Text] [Related]
13. Population and individual bioequivalence: lessons from real data and simulation studies.
Zariffa NM; Patterson SD
J Clin Pharmacol; 2001 Aug; 41(8):811-22. PubMed ID: 11504268
[TBL] [Abstract][Full Text] [Related]
14. Assessing bioequivalence and drug interchangeability.
Chen M; Chow SC
J Biopharm Stat; 2017; 27(2):272-281. PubMed ID: 27936343
[TBL] [Abstract][Full Text] [Related]
15. On assessment of bioequivalence under a higher-order crossover design.
Chow SC; Liu JP
J Biopharm Stat; 1992; 2(2):239-56. PubMed ID: 1300216
[TBL] [Abstract][Full Text] [Related]
16. Subject-by-formulation interaction in bioequivalence: conceptual and statistical issues. FDA Population/Individual Bioequivalence Working Group. Food and Drug Administration.
Hauck WW; Hyslop T; Chen ML; Patnaik R; Williams RL
Pharm Res; 2000 Apr; 17(4):375-80. PubMed ID: 10870978
[TBL] [Abstract][Full Text] [Related]
17. PhRMA perspective on population and individual bioequivalence.
Barrett JS; Batra V; Chow A; Cook J; Gould AL; Heller AH; Lo MW; Patterson SD; Smith BP; Stritar JA; Vega JM; Zariffa N
J Clin Pharmacol; 2000 Jun; 40(6):561-70. PubMed ID: 10868305
[TBL] [Abstract][Full Text] [Related]
18. Alternative confidence intervals for the assessment of bioequivalence in four-period cross-over designs.
Quiroz J; Ting N; Wei GC; Burdick RK
Stat Med; 2002 Jul; 21(13):1825-47. PubMed ID: 12111892
[TBL] [Abstract][Full Text] [Related]
19. The bioequivalence of highly variable drugs and drug products.
Midha KK; Rawson MJ; Hubbard JW
Int J Clin Pharmacol Ther; 2005 Oct; 43(10):485-98. PubMed ID: 16240706
[TBL] [Abstract][Full Text] [Related]
20. Use of the repeated cross-over designs in assessing bioequivalence.
Liu JP
Stat Med; 1995 May 15-30; 14(9-10):1067-78; discussion 1079-80. PubMed ID: 7569501
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
