276 related articles for article (PubMed ID: 22903309)
1. Comments on the FDA draft guidance on biosimilar products.
Chow SC; Endrenyi L; Lachenbruch PA
Stat Med; 2013 Feb; 32(3):364-9. PubMed ID: 22903309
[TBL] [Abstract][Full Text] [Related]
2. Scientific considerations for assessing biosimilar products.
Chow SC; Wang J; Endrenyi L; Lachenbruch PA
Stat Med; 2013 Feb; 32(3):370-81. PubMed ID: 22933240
[TBL] [Abstract][Full Text] [Related]
3. The US approach to biosimilars: the long-awaited FDA approval pathway.
Calvo B; Zuñiga L
BioDrugs; 2012 Dec; 26(6):357-61. PubMed ID: 23030677
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. 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]
6. Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.
Lin JR; Chow SC; Chang CH; Lin YC; Liu JP
Stat Med; 2013 Feb; 32(3):449-61. PubMed ID: 22911920
[TBL] [Abstract][Full Text] [Related]
7. 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]
8. Assessing biosimilarity and interchangeability of biosimilar products.
Chow SC
Stat Med; 2013 Feb; 32(3):361-3. PubMed ID: 23307569
[No Abstract] [Full Text] [Related]
9. Biosimilar draft guidance issue by US FDA.
Payne T
Bioanalysis; 2012 Apr; 4(7):759. PubMed ID: 22512794
[No Abstract] [Full Text] [Related]
10. Interchangeability Of Biological Drug Products-FDA Draft Guidance.
Endrenyi L; Markus R
J Biopharm Stat; 2019; 29(6):1003-1010. PubMed ID: 31023141
[TBL] [Abstract][Full Text] [Related]
11. 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]
12. 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]
13. Comparability of critical quality attributes for establishing biosimilarity.
Liao JJ; Darken PF
Stat Med; 2013 Feb; 32(3):462-9. PubMed ID: 22903263
[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. 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]
16. Biosimilar safety factors in clinical practice.
Reinisch W; Smolen J
Semin Arthritis Rheum; 2015 Jun; 44(6 Suppl):S9-15. PubMed ID: 26058551
[TBL] [Abstract][Full Text] [Related]
17. An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology.
Nikolov NP; Shapiro MA
Nat Rev Rheumatol; 2017 Feb; 13(2):123-128. PubMed ID: 28053335
[TBL] [Abstract][Full Text] [Related]
18. Biosimilars: the need, the challenge, the future: the FDA perspective.
Epstein MS; Ehrenpreis ED; Kulkarni PM;
Am J Gastroenterol; 2014 Dec; 109(12):1856-9. PubMed ID: 24957160
[TBL] [Abstract][Full Text] [Related]
19. International Conference on Harmonisation; guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products. Notice. Food and Drug Administration, HHS.
Fed Regist; 1999 Aug; 64(159):44928-35. PubMed ID: 12356094
[TBL] [Abstract][Full Text] [Related]
20. FDA draft guidance on adaptive design clinical trials: Pfizer's perspective.
Chuang-Stein C; Beltangady M
J Biopharm Stat; 2010 Nov; 20(6):1143-9. PubMed ID: 21058110
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]