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1.
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 15(16): 955-1016, 2023 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-37650500
2.
Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy.
Bioanalysis
; 14(13): 911-917, 2022 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-35904153
3.
Recommendations on qPCR/ddPCR assay validation by GCC.
Bioanalysis
; 14(12): 853-863, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35703321
4.
Recommendations on ELISpot assay validation by the GCC.
Bioanalysis
; 14(4): 187-193, 2022 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-35135309
5.
Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial.
Pediatr Diabetes
; 9(6): 554-60, 2008 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-18761644
6.
EBF recommendation on practical management of critical reagents for PK ligand-binding assays.
Bioanalysis
; 10(19): 1557-1565, 2018 Oct 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-30226086
7.
Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.
Bioanalysis
; 10(4): 197-204, 2018 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-29345496
8.
Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum.
Bioanalysis
; 9(16): 1253-1264, 2017 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-28766359
9.
Feedback from the EBF - Focus Workshop: bringing assay validation and analysis of biomarkers into practice.
Bioanalysis
; 9(9): 675-681, 2017 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-28520459
10.
Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective.
Bioanalysis
; 9(19): 1493-1508, 2017 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-29056059
11.
C5a and C5aR are elevated in joints of rheumatoid and psoriatic arthritis patients, and C5aR blockade attenuates leukocyte migration to synovial fluid.
PLoS One
; 12(12): e0189017, 2017.
Artículo
en Inglés
| MEDLINE | ID: mdl-29220376
12.
Mitogen- and stress-activated protein kinase 1 is activated in lesional psoriatic epidermis and regulates the expression of pro-inflammatory cytokines.
J Invest Dermatol
; 126(8): 1784-91, 2006 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-16543895
13.
Co-medication and interference testing in bioanalysis: a European Bioanalysis Forum recommendation.
Bioanalysis
; 8(19): 2065-70, 2016 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-27416776
14.
Tiered approach into practice: scientific validation for chromatography-based assays in early development - a recommendation from the European Bioanalysis Forum.
Bioanalysis
; 7(18): 2387-2398, 2015 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-26354595
15.
Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis.
Adv Ther
; 32(3): 228-38, 2015 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-25749867
16.
Emerging technologies to increase ligand binding assay sensitivity.
AAPS J
; 17(1): 93-101, 2015 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-25331105
17.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).
Bioanalysis
; 7(24): 3107-24, 2015 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-26635247
18.
Synthesis and structure-activity relationship of aminobenzophenones. A novel class of p38 MAP kinase inhibitors with high antiinflammatory activity.
J Med Chem
; 46(26): 5651-62, 2003 Dec 18.
Artículo
en Inglés
| MEDLINE | ID: mdl-14667219
19.
How the bioanalytical scientist plays a key role in interdisciplinary project teams in the development of biotherapeutics - a reflection of the European Bioanalysis Forum.
Bioanalysis
; 6(10): 1339-48, 2014 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-24958118
20.
Toward decision-based acceptance criteria for Bioanalytical Method Validation: a proposal for discussion from the European Bioanalysis Forum.
Bioanalysis
; 10(16): 1255-1259, 2018 Aug 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-30130129