123 related articles for article (PubMed ID: 20077250)
1. Statistical test for evaluation of biosimilarity in variability of follow-on biologics.
Hsieh TC; Chow SC; Liu JP; Hsiao CF; Chi E
J Biopharm Stat; 2010 Jan; 20(1):75-89. PubMed ID: 20077250
[TBL] [Abstract][Full Text] [Related]
2. A comparison of moment-based and probability-based criteria for assessment of follow-on biologics.
Chow SC; Hsieh TC; Chi E; Yang J
J Biopharm Stat; 2010 Jan; 20(1):31-45. PubMed ID: 20077247
[TBL] [Abstract][Full Text] [Related]
3. Statistical methods for assessment of biosimilarity using biomarker data.
Chow SC; Lu Q; Tse SK; Chi E
J Biopharm Stat; 2010 Jan; 20(1):90-105. PubMed ID: 20077251
[TBL] [Abstract][Full Text] [Related]
4. Nonparametric tests for evaluation of biosimilarity in variability of follow-on biologics.
Zhang N; Yang J; Chow SC; Chi E
J Biopharm Stat; 2014; 24(6):1239-53. PubMed ID: 25036940
[TBL] [Abstract][Full Text] [Related]
5. The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics.
Hsieh TC; Chow SC; Yang LY; Chi E
Stat Med; 2013 Feb; 32(3):406-14. PubMed ID: 22899403
[TBL] [Abstract][Full Text] [Related]
6. Evaluating statistical methods to establish clinical similarity of two biologics.
Lei L; Olson K
J Biopharm Stat; 2010 Jan; 20(1):62-74. PubMed ID: 20077249
[TBL] [Abstract][Full Text] [Related]
7. An adapted F-test for homogeneity of variability in follow-on biological products.
Yang J; Zhang N; Chow SC; Chi E
Stat Med; 2013 Feb; 32(3):415-23. PubMed ID: 22933180
[TBL] [Abstract][Full Text] [Related]
8. Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics.
Zhang N; Yang J; Chow SC; Endrenyi L; Chi E
Stat Med; 2013 Feb; 32(3):424-33. PubMed ID: 22933127
[TBL] [Abstract][Full Text] [Related]
9. Statistical assessment of biosimilar products.
Chow SC; Liu JP
J Biopharm Stat; 2010 Jan; 20(1):10-30. PubMed ID: 20077246
[TBL] [Abstract][Full Text] [Related]
10. Statistical methods for assessing interchangeability of biosimilars.
Chow SC; Yang LY; Starr A; Chiu ST
Stat Med; 2013 Feb; 32(3):442-8. PubMed ID: 22899372
[TBL] [Abstract][Full Text] [Related]
11. The challenge of follow-on biologics for treatment of multiple sclerosis.
Reingold SC; Steiner JP; Polman CH; Cohen JA; Freedman MS; Kappos L; Thompson AJ; Wolinsky JS
Neurology; 2009 Aug; 73(7):552-9. PubMed ID: 19687456
[TBL] [Abstract][Full Text] [Related]
12. Frequency estimator for assessing of follow-on biologics.
Lu Y; Zhang ZZ; Chow SC
J Biopharm Stat; 2014; 24(6):1280-97. PubMed ID: 25072640
[TBL] [Abstract][Full Text] [Related]
13. Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability.
Davis GC; Beals JM; Johnson C; Mayer MH; Meiklejohn BI; Mitlak BH; Roth JL; Towns JK; Veenhuizen M
Curr Med Res Opin; 2009 Jul; 25(7):1655-61. PubMed ID: 19476407
[TBL] [Abstract][Full Text] [Related]
14. Statistical assessment of biosimilarity based on relative distance between follow-on biologics.
Kang SH; Chow SC
Stat Med; 2013 Feb; 32(3):382-92. PubMed ID: 22941672
[TBL] [Abstract][Full Text] [Related]
15. Basic facts about biosimilars.
Nowicki M
Kidney Blood Press Res; 2007; 30(5):267-72. PubMed ID: 17622764
[TBL] [Abstract][Full Text] [Related]
16. Estimation and approximation approaches for biosimilar index based on reproducibility probability.
Yang LY; Lai CH
J Biopharm Stat; 2014; 24(6):1298-311. PubMed ID: 25033191
[TBL] [Abstract][Full Text] [Related]
17. Assessing the bioequivalence of biosimilars The Retacrit case.
Schellekens H
Drug Discov Today; 2009 May; 14(9-10):495-9. PubMed ID: 19429509
[TBL] [Abstract][Full Text] [Related]
18. Pilot trial for the assessment of relative bioavailability in generic drug product development: statistical power.
Wang Y; Zhou S
J Biopharm Stat; 1999 Mar; 9(1):179-87. PubMed ID: 10091917
[TBL] [Abstract][Full Text] [Related]
19. Evaluation of product comparability.
Builder SE
Dev Biol Stand; 1998; 96():83-90. PubMed ID: 9890520
[No Abstract] [Full Text] [Related]
20. Scientific and regulatory considerations on the immunogenicity of biologics.
Shankar G; Shores E; Wagner C; Mire-Sluis A
Trends Biotechnol; 2006 Jun; 24(6):274-80. PubMed ID: 16631266
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]