Detalhe da pesquisa
1.
Application of blood microsampling in cynomolgus monkey and demonstration of equivalent monoclonal antibody PK parameters compared to conventional sampling.
Pharm Res
; 38(5): 819-830, 2021 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-33982224
2.
Fit-for-Purpose Validation of a Ligand Binding Assay for Toxicokinetic Study Using Mouse Serial Sampling.
Pharm Res
; 36(12): 169, 2019 Oct 25.
Artigo
em Inglês
| MEDLINE | ID: mdl-31654236
3.
Engineering a monomeric Fc domain modality by N-glycosylation for the half-life extension of biotherapeutics.
J Biol Chem
; 288(23): 16529-16537, 2013 Jun 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-23615911
4.
Comparison of succinimidyl [(125)I]iodobenzoate with iodogen iodination methods to study pharmacokinetics and ADME of biotherapeutics.
Pharm Res
; 31(10): 2810-21, 2014 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-24844406
5.
One mouse, one pharmacokinetic profile: quantitative whole blood serial sampling for biotherapeutics.
Pharm Res
; 31(7): 1823-33, 2014 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-24464271
6.
Pharmacokinetic, biodistribution, and biophysical profiles of TNF nanobodies conjugated to linear or branched poly(ethylene glycol).
Bioconjug Chem
; 23(7): 1452-62, 2012 Jul 18.
Artigo
em Inglês
| MEDLINE | ID: mdl-22731748
7.
Determination of Anti-drug Antibody Affinity in Clinical Study Samples Provides a Tool for Evaluation of Immune Response Maturation.
AAPS J
; 24(6): 114, 2022 11 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-36324032
8.
Critical reagent characterization and re-evaluation to ensure long-term stability: two case studies.
Bioanalysis
; 13(10): 807-815, 2021 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-33884894
9.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 13(5): 295-361, 2021 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-33511867
10.
GDF-15 Neutralization Alleviates Platinum-Based Chemotherapy-Induced Emesis, Anorexia, and Weight Loss in Mice and Nonhuman Primates.
Cell Metab
; 32(6): 938-950.e6, 2020 12 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-33207247
11.
An Assessment of LRRK2 Serine 935 Phosphorylation in Human Peripheral Blood Mononuclear Cells in Idiopathic Parkinson's Disease and G2019S LRRK2 Cohorts.
J Parkinsons Dis
; 10(2): 623-629, 2020.
Artigo
em Inglês
| MEDLINE | ID: mdl-32007961
12.
Neutralizing Antibody Assay Development with High Drug and Target Tolerance to Support Clinical Development of an Anti-TFPI Therapeutic Monoclonal Antibody.
AAPS J
; 21(3): 46, 2019 03 29.
Artigo
em Inglês
| MEDLINE | ID: mdl-30927117
13.
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.
Artigo
em Inglês
| MEDLINE | ID: mdl-31820675
14.
Glyco-engineered Long Acting FGF21 Variant with Optimal Pharmaceutical and Pharmacokinetic Properties to Enable Weekly to Twice Monthly Subcutaneous Dosing.
Sci Rep
; 8(1): 4241, 2018 03 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-29523796
15.
A Multi-site In-depth Evaluation of the Quanterix Simoa from a User's Perspective.
AAPS J
; 20(1): 10, 2017 12 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-29196830
16.
Preclinical Pharmacokinetics, Pharmacodynamics, Tissue Distribution, and Interspecies Scaling of Recombinant Human Coagulation Factor XaI16L.
J Pharm Sci
; 106(8): 2136-2143, 2017 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-28389265
17.
Feasibility of Singlet Analysis for Ligand Binding Assays: a Retrospective Examination of Data Generated Using the Gyrolab Platform.
AAPS J
; 18(5): 1300-1308, 2016 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-27401185
18.
Utility of a human FcRn transgenic mouse model in drug discovery for early assessment and prediction of human pharmacokinetics of monoclonal antibodies.
MAbs
; 8(6): 1064-78, 2016.
Artigo
em Inglês
| MEDLINE | ID: mdl-27232760
19.
Emerging technologies to increase ligand binding assay sensitivity.
AAPS J
; 17(1): 93-101, 2015 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-25331105
20.
Faster in vivo clearance of human embryonic kidney than Chinese hamster ovary cell derived protein: Role of glycan mediated clearance.
J Biosci Bioeng
; 119(6): 657-60, 2015 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-25575972