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1.
Plasma glucosylsphingosine correlations with baseline disease burden and response to eliglustat in two clinical trials of previously untreated adults with Gaucher disease type 1.
Mol Genet Metab
; 138(3): 107527, 2023 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-36739645
2.
Long-term efficacy of olipudase alfa in adults with acid sphingomyelinase deficiency (ASMD): Further clearance of hepatic sphingomyelin is associated with additional improvements in pro- and anti-atherogenic lipid profiles after 42 months of treatment.
Mol Genet Metab
; 131(1-2): 245-252, 2020.
Artículo
en Inglés
| MEDLINE | ID: mdl-32620536
3.
Olipudase alfa for treatment of acid sphingomyelinase deficiency (ASMD): safety and efficacy in adults treated for 30 months.
J Inherit Metab Dis
; 41(5): 829-838, 2018 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-29305734
4.
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
5.
Criteria of slope and endogenous level for selection of matrix in the quantitation of endogenous compounds by LC-MS/MS.
Bioanalysis
; 14(11): 807-816, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35938284
6.
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 14(9): 505-580, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578993
7.
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral Venglustat in Healthy Volunteers.
Clin Pharmacol Drug Dev
; 10(1): 86-98, 2021 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-32851809
8.
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos).
Bioanalysis
; 13(4): 203-238, 2021 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-33470871
9.
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Bioanalysis
; 11(24): 2207-2244, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31820675
10.
A sensitive human bone assay for quantitation of tigecycline using LC/MS/MS.
J Pharm Biomed Anal
; 48(3): 866-75, 2008 Nov 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-18692977
11.
2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Bioanalysis
; 10(22): 1781-1801, 2018 Nov 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-30488725
12.
A novel antibiotic bone assay by liquid chromatography/tandem mass spectrometry for quantitation of tigecycline in rat bone.
J Pharm Biomed Anal
; 44(4): 970-9, 2007 Aug 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-17537611
13.
Enhancement of human plasma glucosylceramide assay sensitivity using delipidized plasma.
Mol Genet Metab Rep
; 8: 77-9, 2016 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-27547732
14.
A novel approach for quantitation of glucosylceramide in human dried blood spot using LC-MS/MS.
Bioanalysis
; 7(12): 1483-96, 2015.
Artículo
en Inglés
| MEDLINE | ID: mdl-26168255
15.
Reassessment of tigecycline bone concentrations in volunteers undergoing elective orthopedic procedures.
J Clin Pharmacol
; 54(1): 70-4, 2014 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-24155157
16.
Ultrasensitive and automated 1 pg/ml fluticasone propionate assay in human plasma using LC-MS/MS.
Bioanalysis
; 5(4): 423-35, 2013 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-23414376
17.
Challenges in urine bioanalytical assays: overcoming nonspecific binding.
Bioanalysis
; 2(9): 1573-86, 2010 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-21083286
18.
Determination of tigecycline in human skin using a novel validated LC-MS/MS method.
Bioanalysis
; 2(1): 81-94, 2010 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-21083122
19.
Evaluation of PAI-039 [{1-benzyl-5-[4-(trifluoromethoxy)phenyl]-1H-indol-3-yl}(oxo)acetic acid], a novel plasminogen activator inhibitor-1 inhibitor, in a canine model of coronary artery thrombosis.
J Pharmacol Exp Ther
; 314(2): 710-6, 2005 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-15860572
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