Found: 17
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Best Practices for Development and Validation of Enzymatic Activity Assays to Support Drug Development for Inborn Errors of Metabolism and Biomarker Assessment.
- Published in:
- AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00966-y
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- Publication type:
- Article
Neutralizing Antibody Validation Testing and Reporting Harmonization.
- Published in:
- AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00830-5
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- Publication type:
- Article
Biological Matrix Supply Chain Shortages: More Matrices Are Now Rare—the Case for Surrogate Matrices.
- Published in:
- 2022
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- Publication type:
- Editorial
Anti-drug Antibody Validation Testing and Reporting Harmonization.
- Published in:
- AAPS Journal, 2022, v. 24, n. 1, p. 1, doi. 10.1208/s12248-021-00649-y
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- Publication type:
- Article
AAPS Workshop Report on ICH M10.
- Published in:
- AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0398-7
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- Publication type:
- Article
Report on the AAPS Immunogenicity Guidance Forum.
- Published in:
- AAPS Journal, 2019, v. 21, n. 4, p. N.PAG, doi. 10.1208/s12248-019-0328-8
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- Publication type:
- Article
Generic Anti-PEG Antibody Assay on ProterixBio’s (Formerly BioScale) ViBE Platform Shows Poor Reproducibility.
- Published in:
- AAPS Journal, 2018, v. 20, n. 3, p. 1, doi. 10.1208/s12248-018-0228-3
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- Publication type:
- Article
Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development.
- Published in:
- AAPS Journal, 2017, v. 19, n. 6, p. 1576, doi. 10.1208/s12248-017-0153-x
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- Publication type:
- Article
Singlicate Ligand Binding Assay Using an Automated Microfluidic System: a Clinical Case Study.
- Published in:
- AAPS Journal, 2017, v. 19, n. 5, p. 1461, doi. 10.1208/s12248-017-0105-5
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- Publication type:
- Article
Pre-existing Antibody: Biotherapeutic Modality-Based Review.
- Published in:
- AAPS Journal, 2016, v. 18, n. 2, p. 311, doi. 10.1208/s12248-016-9878-1
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- Publication type:
- Article
New FDA Draft Guidance on Immunogenicity.
- Published in:
- AAPS Journal, 2014, v. 16, n. 3, p. 499, doi. 10.1208/s12248-014-9587-6
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- Publication type:
- Article
Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team.
- Published in:
- AAPS Journal, 2014, v. 16, n. 1, p. 83, doi. 10.1208/s12248-013-9542-y
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- Publication type:
- Article
Bioanalytical Approaches to Quantify 'Total' and 'Free' Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development.
- Published in:
- AAPS Journal, 2011, v. 13, n. 1, p. 99, doi. 10.1208/s12248-011-9251-3
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- Publication type:
- Article
The pharmacokinetics of peginterferon lambda-1a following single dose administration to subjects with impaired renal function.
- Published in:
- British Journal of Clinical Pharmacology, 2015, v. 80, n. 3, p. 515, doi. 10.1111/bcp.12634
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- Publication type:
- Article
Novel Heparanase-Inhibiting Antibody Reduces Neointima Formation.
- Published in:
- Journal of Biochemistry, 2006, v. 139, n. 3, p. 339, doi. 10.1093/jb/mvj061
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- Publication type:
- Article
Heparanase and Platelet Factor-4 Induce Smooth Muscle Cell Proliferation and Migration via bFGF Release from the ECM1.
- Published in:
- Journal of Biochemistry, 2002, v. 131, n. 6, p. 913, doi. 10.1093/oxfordjournals.jbchem.a003182
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- Publication type:
- Article
FGF21 Analogs of Sustained Action Enabled by Orthogonal Biosynthesis Demonstrate Enhanced Antidiabetic Pharmacology in Rodents.
- Published in:
- Diabetes, 2012, v. 61, n. 2, p. 505, doi. 10.2337/db11-0838
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- Publication type:
- Article