135 related articles for article (PubMed ID: 34205892)
1. New Quality-Range-Setting Method Based on Between- and Within-Batch Variability for Biosimilarity Assessment.
Oliva A; Llabrés M
Pharmaceuticals (Basel); 2021 Jun; 14(6):. PubMed ID: 34205892
[TBL] [Abstract][Full Text] [Related]
2. On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation.
Yang H; Novick S; Burdick RK
PDA J Pharm Sci Technol; 2016 11/12; 70(6):547-559. PubMed ID: 27325594
[TBL] [Abstract][Full Text] [Related]
3. Limitations of the quality range approach in analytical similarity assessment: Effect of mean shift and relative variability.
Oliva A; Llabrés M
J Pharm Biomed Anal; 2021 May; 198():114017. PubMed ID: 33730613
[TBL] [Abstract][Full Text] [Related]
4. Some thoughts on the QR method for analytical similarity evaluation.
Son S; Oh M; Choo M; Chow SC; Lee SJ
J Biopharm Stat; 2020 May; 30(3):521-536. PubMed ID: 32089068
[TBL] [Abstract][Full Text] [Related]
5. A comparative study of confidence intervals to assess biosimilarity from analytical data.
Quiroz J; Montes R; Shi H; Roychoudhury S
Pharm Stat; 2019 May; 18(3):316-328. PubMed ID: 30644636
[TBL] [Abstract][Full Text] [Related]
6. Adjustment for unbalanced sample size for analytical biosimilar equivalence assessment.
Dong XC; Weng YT; Tsong Y
J Biopharm Stat; 2017; 27(2):220-232. PubMed ID: 28060570
[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. Evaluation of analytical similarity between trastuzumab biosimilar CT-P6 and reference product using statistical analyses.
Lee J; Kang HA; Bae JS; Kim KD; Lee KH; Lim KJ; Choo MJ; Chang SJ
MAbs; 2018; 10(4):547-571. PubMed ID: 29482416
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence.
Mangas-Sanjuán V; Pleguezuelos-Villa M; Merino-Sanjuán M; Hernández MJ; Nácher A; García-Arieta A; Peris D; Hidalgo I; Soler L; Sallan M; Merino V
Pharmaceutics; 2019 Oct; 11(10):. PubMed ID: 31581492
[TBL] [Abstract][Full Text] [Related]
11. Considerations of critical quality attributes in the analytical comparability assessment of biosimilar products.
Kwon O; Joung J; Park Y; Kim CW; Hong SH
Biologicals; 2017 Jul; 48():101-108. PubMed ID: 28495312
[TBL] [Abstract][Full Text] [Related]
12. Comparison of glycoprofiles of rituximab versions licensed for sale in India and an analytical approach for quality assessment.
Kaur T; Shukla BN; Yadav VK; Kulkarni MJ; Rao A
J Proteomics; 2021 Jul; 244():104267. PubMed ID: 34015520
[TBL] [Abstract][Full Text] [Related]
13. Batch statistical process control of a fluid bed granulation process using in-line spatial filter velocimetry and product temperature measurements.
Burggraeve A; Van den Kerkhof T; Hellings M; Remon JP; Vervaet C; De Beer T
Eur J Pharm Sci; 2011 Apr; 42(5):584-92. PubMed ID: 21397688
[TBL] [Abstract][Full Text] [Related]
14. Statistical assessment of between batch stability equivalence.
Llabrés M; Oliva A; Fariña J
Int J Pharm; 2000 Aug; 204(1-2):61-8. PubMed ID: 11011987
[TBL] [Abstract][Full Text] [Related]
15. Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms.
Xu Z; Mangas-Sanjuán V; Merino-Sanjuán M; Merino V; García-Arieta A
Pharmaceutics; 2020 Nov; 12(12):. PubMed ID: 33260792
[TBL] [Abstract][Full Text] [Related]
16. Analytical Similarity Assessment in Biosimilar Studies.
Chow SC; Song F; Bai H
AAPS J; 2016 May; 18(3):670-7. PubMed ID: 26873509
[TBL] [Abstract][Full Text] [Related]
17. PAT-based batch statistical process control of a manufacturing process for a pharmaceutical ointment.
Bostijn N; Dhondt W; Vervaet C; De Beer T
Eur J Pharm Sci; 2019 Aug; 136():104946. PubMed ID: 31170525
[TBL] [Abstract][Full Text] [Related]
18. 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]
19. Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review.
Alsamil AM; Giezen TJ; Egberts TC; Leufkens HG; Vulto AG; van der Plas MR; Gardarsdottir H
Eur J Pharm Sci; 2020 Nov; 154():105501. PubMed ID: 32739253
[TBL] [Abstract][Full Text] [Related]
20.
; ; . PubMed ID:
[No Abstract] [Full Text] [Related]
[Next] [New Search]
