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1.
NMR spectroscopy goes mobile: Using NMR as process analytical technology at the fume hood.
Magn Reson Chem
; 58(12): 1193-1202, 2020 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-32364631
2.
Models and Approaches Describing the Metabolism, Transport, and Toxicity of Drugs Administered by the Ocular Route.
Drug Metab Dispos
; 46(11): 1670-1683, 2018 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-30111625
3.
Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges.
Regul Toxicol Pharmacol
; 98: 98-107, 2018 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-30026135
4.
Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics.
Regul Toxicol Pharmacol
; 86: 221-230, 2017 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-28322894
5.
Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies.
Regul Toxicol Pharmacol
; 73(1): 265-75, 2015 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-26219199
6.
Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
Mol Ther Methods Clin Dev
; 32(1): 101217, 2024 Mar 14.
Artículo
en Inglés
| MEDLINE | ID: mdl-38496304
7.
Identification and enrichment of a UV-induced degradant of Anagrelide drug substance.
J Pharm Biomed Anal
; 229: 115352, 2023 May 30.
Artículo
en Inglés
| MEDLINE | ID: mdl-36989665
8.
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.
AAPS J
; 25(3): 47, 2023 04 26.
Artículo
en Inglés
| MEDLINE | ID: mdl-37101079
9.
Corrigendum to "Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics" [Regul. Toxicol. Pharmacol. (2017) 221-230].
Regul Toxicol Pharmacol
; 88: 364, 2017 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-28431771
10.
Single-Dose Intrathecal Dorsal Root Ganglia Toxicity of Onasemnogene Abeparvovec in Cynomolgus Monkeys.
Hum Gene Ther
; 33(13-14): 740-756, 2022 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-35331006
11.
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Bioanalysis
; 14(11): 737-793, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578991
12.
Analysis of two commercially available bortezomib products: differences in assay of active agent and impurity profile.
AAPS PharmSciTech
; 12(2): 461-7, 2011 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-21455817
13.
Protecting Against Tax ID Theft and Avoiding Other Fraudulent Tax Schemes.
Mo Med
; 113(1): 22-4, 2016.
Artículo
en Inglés
| MEDLINE | ID: mdl-27039484
14.
Immunogenicity Risk Assessment for Multi-specific Therapeutics.
AAPS J
; 23(6): 115, 2021 11 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-34741215
15.
Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays.
AAPS J
; 23(6): 108, 2021 09 16.
Artículo
en Inglés
| MEDLINE | ID: mdl-34529177
16.
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bioanalysis
; 13(6): 415-463, 2021 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-33533276
17.
Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays.
AAPS J
; 22(2): 24, 2020 01 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-31907680
18.
Correction to: Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays.
AAPS J
; 22(2): 42, 2020 Feb 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-32020345
19.
PhRMA white paper on ADME pharmacogenomics.
J Clin Pharmacol
; 48(7): 849-89, 2008 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-18524998
20.
Nonclinical Safety Evaluation of scAAV8-RLBP1 for Treatment of RLBP1 Retinitis Pigmentosa.
Mol Ther Methods Clin Dev
; 8: 105-120, 2018 Mar 16.
Artículo
en Inglés
| MEDLINE | ID: mdl-29359172