Detalhe da pesquisa
1.
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Bioanalysis
; 16(7): 77-119, 2024 Apr.
Artigo
Inglês
| MEDLINE | ID: mdl-38389403
2.
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study.
AAPS J
; 25(5): 85, 2023 09 02.
Artigo
Inglês
| MEDLINE | ID: mdl-37658997
3.
Neutralizing Antibody Validation Testing and Reporting Harmonization.
AAPS J
; 25(4): 69, 2023 07 08.
Artigo
Inglês
| MEDLINE | ID: mdl-37421491
4.
A sensitive LC-MS/MS assay for the determination of dextromethorphan and metabolites in human urine--application for drug interaction studies assessing potential CYP3A and CYP2D6 inhibition.
J Pharm Biomed Anal
; 30(1): 113-24, 2002 Aug 22.
Artigo
Inglês
| MEDLINE | ID: mdl-12151071
5.
Safety and pharmacology of ponezumab (PF-04360365) after a single 10-minute intravenous infusion in subjects with mild to moderate Alzheimer disease.
Clin Neuropharmacol
; 36(1): 8-13, 2013.
Artigo
Inglês
| MEDLINE | ID: mdl-23334069
6.
Safety and pharmacology of a single intravenous dose of ponezumab in subjects with mild-to-moderate Alzheimer disease: a phase I, randomized, placebo-controlled, double-blind, dose-escalation study.
Clin Neuropharmacol
; 36(1): 14-23, 2013.
Artigo
Inglês
| MEDLINE | ID: mdl-23334070