Works matching IS 15507416 AND DT 2025 AND VI 27 AND IP 1
Results: 29
Impact of Weak Vibration Generated by a Refrigerator on Protein Aggregation.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01014-z
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- Publication type:
- Article
Evaluating the Immunogenicity Risk of Protein Therapeutics by Augmenting T Cell Epitope Prediction with Clinical Factors.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01003-8
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- Publication type:
- Article
Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01019-8
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- Publication type:
- Article
Gastrointestinal Bile Salt Concentrations in Healthy Adults Under Fasted and Fed Conditions: A Systematic Review and Meta-Analysis for Mechanistic Physiologically-Based Pharmacokinetic (PBPK) Modelling.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01016-x
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- Publication type:
- Article
Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01015-y
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- Publication type:
- Article
Formulation Factors Affecting the Formation of Visible-Bubbles During the Reconstitution Process of Freeze-Dried Etanercept Formulations: Protein Concentration, Stabilizers, and Surfactants.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01009-2
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- Publication type:
- Article
Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00993-9
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- Publication type:
- Article
Innovative Approaches in Regulatory Affairs: Leveraging Artificial Intelligence and Machine Learning for Efficient Compliance and Decision-Making.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01006-5
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- Publication type:
- Article
Tumor-Infiltration Mimicking Model of Contaminated Ovarian Tissue as an Innovative Platform for Advanced Cancer Research.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00997-5
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- Publication type:
- Article
Correction: Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation.
- Published in:
- 2025
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- Publication type:
- Correction Notice
Meta-Analysis of the Input and Disposition of Various Dosage Forms of Methylprednisolone in Healthy Subjects Utilizing a Physiologically Based Pharmacokinetic Model: Pharmacokinetics of Methylprednisolone in Humans: Yu and Jusko.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01011-8
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- Publication type:
- Article
Simultaneous Quantification of Total Antibody and Conjugated Payload for DS001 in Rat Serum Using a Hybrid Immuno-Capture LC–MS/MS.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01007-4
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- Publication type:
- Article
Comparison of RT-qPCR With Branched DNA to Quantify a Lipid Nanoparticle–Encapsulated mRNA Therapeutic in Serum and Liver Tissue Samples From Nonclinical PK Studies.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01002-9
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- Publication type:
- Article
Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRAS<sup>G12C</sup> Mutation from Phase 1 and Phase 2 Studies.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01013-6
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- Publication type:
- Article
Early and Mid-Term Disposition of α-PVP and its unknown Metabolites in Urine and Oral Fluid Through a Multi-Analytical Hyphenated Approach Following a Single Non-Controlled Administration to Healthy Volunteers.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01012-7
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- Publication type:
- Article
Reformation of a Clinical Anti-Drug Antibody Assay to Enable the Immunogenicity Assessment of a Bispecific Antibody Biotherapeutic.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00996-6
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- Publication type:
- Article
Recommendation for Clarifying FDA Policy in Evaluating "Sameness" of Higher Order Structure for Generic Peptide Therapeutics.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00994-8
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- Publication type:
- Article
Innovative Approaches in Regulatory Affairs: Leveraging Artificial Intelligence and Machine Learning for Efficient Compliance and Decision-Making.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01006-5
- By:
- Publication type:
- Article
Development of Solidified Self-microemulsifying Delivery Systems Containing Tacrolimus for Enhanced Dissolution and Pharmacokinetic Profile.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00992-w
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- Publication type:
- Article
Exploring the Correlation between LC–MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00973-z
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- Publication type:
- Article
Rejoinder to the 'Letter to the Editor' on "Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies".
- Published in:
- 2025
- By:
- Publication type:
- Letter
Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00991-x
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- Publication type:
- Article
Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01001-w
- By:
- Publication type:
- Article
Evaluation of Incurred Subject Period Re-analysis (ISPR) as a Tool to Distinguish Fraudulent Pharmacokinetic Profile Pairs from Non-fraudulent Pairs.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01000-x
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- Publication type:
- Article
Interference of Plasticizers on Plasma Protein Binding Measurements.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00988-6
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- Publication type:
- Article
Precision Nanomedicine: Lapatinib-Loaded Chitosan-Gold Nanoparticles Targeting LINC01615 for Lung Cancer Therapy.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00990-y
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- Publication type:
- Article
Prediction of Drug-Drug Interactions for Highly Plasma Protein Bound Compounds.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00987-7
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- Publication type:
- Article
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00986-8
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- Publication type:
- Article
A Data Driven Strategy for Implementation of Singlicate Analysis in Ligand Binding Assays Used for the Determination of Anti-drug Antibodies to a Multidomain Biotherapeutic.
- Published in:
- AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00984-w
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- Publication type:
- Article