160 related articles for article (PubMed ID: 25032488)
1. Applications of the bayesian prior information to evaluation of equivalence of similar biological medicinal products.
Chiu ST; Liu JP; Chow SC
J Biopharm Stat; 2014; 24(6):1254-63. PubMed ID: 25032488
[TBL] [Abstract][Full Text] [Related]
2. A consistency approach for evaluation of biosimilar products.
Tsou HH; Chang WJ; Hwang WS; Lai YH
J Biopharm Stat; 2013; 23(5):1054-66. PubMed ID: 23957515
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. 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]
5. Sample size calculations for the development of biosimilar products.
Kang SH; Kim Y
J Biopharm Stat; 2014; 24(6):1215-24. PubMed ID: 25032735
[TBL] [Abstract][Full Text] [Related]
6. 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]
7. Scientific factors and current issues in biosimilar studies.
Chow SC; Endrenyi L; Lachenbruch PA; Mentré F
J Biopharm Stat; 2014; 24(6):1138-53. PubMed ID: 25098559
[TBL] [Abstract][Full Text] [Related]
8. Clinical development and trial design of biosimilar products: a Japanese perspective.
Nagasaki M; Ando Y
J Biopharm Stat; 2014; 24(6):1165-72. PubMed ID: 25033370
[TBL] [Abstract][Full Text] [Related]
9. Biosimilar safety considerations in clinical practice.
Choy E; Jacobs IA
Semin Oncol; 2014 Feb; 41 Suppl 1():S3-14. PubMed ID: 24560025
[TBL] [Abstract][Full Text] [Related]
10. Initial steps in the regulation of generic biological drugs: a comparison of U.S. and Canadian regimes.
Szeto KJ; Wolanski M
Food Drug Law J; 2012; 67(2):131-41, i. PubMed ID: 24620416
[TBL] [Abstract][Full Text] [Related]
11. 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]
12. Statistical assessment of biosimilarity based on the relative distance between follow-on biologics for binary endpoints.
Shin W; Kang SH
J Biopharm Stat; 2016; 26(2):227-39. PubMed ID: 25372220
[TBL] [Abstract][Full Text] [Related]
13. Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab.
Ebbers HC; van Meer PJ; Moors EH; Mantel-Teeuwisse AK; Leufkens HG; Schellekens H
Drug Discov Today; 2013 Sep; 18(17-18):872-9. PubMed ID: 23688584
[TBL] [Abstract][Full Text] [Related]
14. Global regulatory standards for the approval of biosimilars.
Mounho B; Phillips A; Holcombe K; Grampp G; Lubiniecki T; Mollerup I; Jones C
Food Drug Law J; 2010; 65(4):819-37, ii-iii. PubMed ID: 24479248
[TBL] [Abstract][Full Text] [Related]
15. Use of prior information for Bayesian evaluation of bridging studies.
Hsiao CF; Hsu YY; Tsou HH; Liu JP
J Biopharm Stat; 2007; 17(1):109-21. PubMed ID: 17219758
[TBL] [Abstract][Full Text] [Related]
16. Statistical considerations in biosimilar clinical efficacy trials with asymmetrical margins.
Li Y; Liu Q; Wood P; Johri A
Stat Med; 2013 Feb; 32(3):393-405. PubMed ID: 22991275
[TBL] [Abstract][Full Text] [Related]
17. "Biosimilars": towards fewer obstacles to their use.
Prescrire Int; 2015 Mar; 24(158):80-1, 83. PubMed ID: 25897464
[TBL] [Abstract][Full Text] [Related]
18. The scope and requirements related to preclinical and clinical studies of a new medicinal product, including biotechnological and biosimilar products.
Brodniewicz-Proba T
Acta Pol Pharm; 2008; 65(6):641-5. PubMed ID: 19172845
[TBL] [Abstract][Full Text] [Related]
19. 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]
20. From Bioequivalence to Biosimilarity: The Rise of a Novel Regulatory Framework.
Karalis VD
Drug Res (Stuttg); 2016 Jan; 66(1):1-6. PubMed ID: 25894088
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
