323 related articles for article (PubMed ID: 24027111)
1. The use of pharmacometrics to optimize biosimilar development.
Dodds M; Chow V; Markus R; Pérez-Ruixo JJ; Shen D; Gibbs M
J Pharm Sci; 2013 Nov; 102(11):3908-14. PubMed ID: 24027111
[TBL] [Abstract][Full Text] [Related]
2. Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins.
Wang YC; Wang Y; Schrieber SJ; Earp J; Thway TM; Huang SM; Zineh I; Christl L
J Pharm Sci; 2019 Jan; 108(1):73-77. PubMed ID: 30395832
[TBL] [Abstract][Full Text] [Related]
3. Biosimilar monoclonal antibodies: preclinical and clinical development aspects.
Gonçalves J; Araújo F; Cutolo M; Fonseca JE
Clin Exp Rheumatol; 2016; 34(4):698-705. PubMed ID: 27383278
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. Considerations in the early development of biosimilar products.
Li EC; Abbas R; Jacobs IA; Yin D
Drug Discov Today; 2015 May; 20 Suppl 2():1-9. PubMed ID: 25572407
[TBL] [Abstract][Full Text] [Related]
6. Improving the power to establish clinical similarity in a Phase 3 efficacy trial by incorporating prior evidence of analytical and pharmacokinetic similarity.
Zeng D; Pan J; Hu K; Chi E; Lin DY
J Biopharm Stat; 2018; 28(2):320-332. PubMed ID: 29173074
[TBL] [Abstract][Full Text] [Related]
7. Application of Pharmacometric Analysis in the Design of Clinical Pharmacology Studies for Biosimilar Development.
Zhu P; Sy SKB; Skerjanec A
AAPS J; 2018 Mar; 20(2):40. PubMed ID: 29516330
[TBL] [Abstract][Full Text] [Related]
8. Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development.
Cai XY; Thomas J; Cullen C; Gouty D
Bioanalysis; 2012 Sep; 4(17):2169-77. PubMed ID: 23013399
[TBL] [Abstract][Full Text] [Related]
9. Using Clinical PK/PD Studies to Support No Clinically Meaningful Differences Between a Proposed Biosimilar and the Reference Product.
Zhu P; Ji P; Wang Y
AAPS J; 2018 Aug; 20(5):89. PubMed ID: 30094524
[No Abstract] [Full Text] [Related]
10. Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs.
Colbert A; Umble-Romero A; Prokop S; Chow VF; Wong T; DeSimone D; Zhou L; Pederson S
MAbs; 2014; 6(5):1178-89. PubMed ID: 25517303
[TBL] [Abstract][Full Text] [Related]
11. 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]
12. Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics.
Sörgel F; Schwebig A; Holzmann J; Prasch S; Singh P; Kinzig M
BioDrugs; 2015 Apr; 29(2):123-31. PubMed ID: 25837839
[TBL] [Abstract][Full Text] [Related]
13. [Opportunities and challenges of extrapolation for biosimilars].
Weise M; Wolff-Holz E
Z Gastroenterol; 2016 Nov; 54(11):1211-1216. PubMed ID: 27711947
[TBL] [Abstract][Full Text] [Related]
14. Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?
Tu CL; Wang YL; Hu TM; Hsu LF
BioDrugs; 2019 Aug; 33(4):437-446. PubMed ID: 31111423
[TBL] [Abstract][Full Text] [Related]
15. The first biosimilar approved for the treatment of osteoporosis: results of a comparative pharmacokinetic/pharmacodynamic study.
Takács I; Jókai E; Kováts DE; Aradi I
Osteoporos Int; 2019 Mar; 30(3):675-683. PubMed ID: 30357438
[TBL] [Abstract][Full Text] [Related]
16. Differentiating biosimilarity and comparability in biotherapeutics.
Azevedo V; Hassett B; Fonseca JE; Atsumi T; Coindreau J; Jacobs I; Mahgoub E; O'Brien J; Singh E; Vicik S; Fitzpatrick B
Clin Rheumatol; 2016 Dec; 35(12):2877-2886. PubMed ID: 27734233
[TBL] [Abstract][Full Text] [Related]
17. Market entry of biosimilar low-molecular-weight heparins in Europe: opportunities and challenges.
Simoens S; Huys I
Semin Thromb Hemost; 2013 Apr; 39(3):250-7. PubMed ID: 23235959
[TBL] [Abstract][Full Text] [Related]
18. Analytic characterization of biosimilars.
Sullivan PM; DiGrazia LM
Am J Health Syst Pharm; 2017 Apr; 74(8):568-579. PubMed ID: 28389456
[TBL] [Abstract][Full Text] [Related]
19. Pharmacology of biosimilar candidate drugs in rheumatology: a literature review.
Araújo F; Cordeiro I; Teixeira F; Gonçalves J; Fonseca JE
Acta Reumatol Port; 2014; 39(1):19-26. PubMed ID: 24811458
[TBL] [Abstract][Full Text] [Related]
20. Comparability and biosimilarity: considerations for the healthcare provider.
Lee JF; Litten JB; Grampp G
Curr Med Res Opin; 2012 Jun; 28(6):1053-8. PubMed ID: 22519391
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
