| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
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
|
Liu, Susana
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27 |
1 |
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artikel
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| 2 |
A Highly Sensitive Immunoassay to Enable Quantification of a Nanobody-Based Imaging Agent in Human Serum
|
Guelman, Sebastian
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27 |
1 |
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artikel
|
| 3 |
Analysis on the Impact of U.S. FDA’s Narrow Therapeutic Index Bioequivalence Criteria on Generic Drug Applications
|
Anim Anno, Krista
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27 |
1 |
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artikel
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| 4 |
Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy
|
Abduljalil, Khaled
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27 |
1 |
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artikel
|
| 5 |
Bioanalytical Method Comparison Strategy for Clinical Anti-drug Antibody Immunoassays
|
Elliott, R. J.
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27 |
1 |
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artikel
|
| 6 |
Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder
|
Santos Gomes, Bernardo Filipe
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27 |
1 |
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artikel
|
| 7 |
Cell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin
|
Her, Cheng
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27 |
1 |
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artikel
|
| 8 |
Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials
|
Lai, Ching-Ha
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27 |
1 |
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artikel
|
| 9 |
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
|
Ortiz, Jessica
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27 |
1 |
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artikel
|
| 10 |
Correction: Assessing Immunogenicity in Drug Reviews and Prescribing Information in Japan
|
Ishibai, Mitsuru
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27 |
1 |
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artikel
|
| 11 |
Correction: Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation
|
Zhong, Hao
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27 |
1 |
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artikel
|
| 12 |
Correction: Tumor-Targeted Chemoimmunotherapy with Immune-Checkpoint Blockade for Enhanced Anti-Melanoma Efficacy
|
Li, Man
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27 |
1 |
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artikel
|
| 13 |
Development of a PBPK Model for Lamotrigine which Incorporates Metabolism by UGT2B10: Impact of UGT2B10 Poor Metabolizer Phenotype and Pregnancy
|
Gardner, Iain
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27 |
1 |
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artikel
|
| 14 |
Development of Solidified Self-microemulsifying Delivery Systems Containing Tacrolimus for Enhanced Dissolution and Pharmacokinetic Profile
|
Zeng, Lingjun
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27 |
1 |
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artikel
|
| 15 |
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
|
Di Trana, Annagiulia
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27 |
1 |
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artikel
|
| 16 |
Evaluating the Immunogenicity Risk of Protein Therapeutics by Augmenting T Cell Epitope Prediction with Clinical Factors
|
Hu, Zicheng
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27 |
1 |
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artikel
|
| 17 |
Evaluation of Incurred Subject Period Re-analysis (ISPR) as a Tool to Distinguish Fraudulent Pharmacokinetic Profile Pairs from Non-fraudulent Pairs
|
Fuglsang, Anders
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27 |
1 |
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artikel
|
| 18 |
Exploring the Correlation between LC–MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis
|
Jiang, Tingting
|
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27 |
1 |
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artikel
|
| 19 |
Formulation Factors Affecting the Formation of Visible-Bubbles During the Reconstitution Process of Freeze-Dried Etanercept Formulations: Protein Concentration, Stabilizers, and Surfactants
|
Gao, Han
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27 |
1 |
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artikel
|
| 20 |
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
|
Santos, Laura G. Al-Amiry
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27 |
1 |
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artikel
|
| 21 |
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent
|
Hernández, Magali
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27 |
1 |
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artikel
|
| 22 |
Impact of Dapagliflozin on Hepatic Lipid Metabolism and a Dynamic Model of Ketone Body Levels
|
Wan, Zhijie
|
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27 |
1 |
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artikel
|
| 23 |
Impact of Weak Vibration Generated by a Refrigerator on Protein Aggregation
|
Kizuki, Shinji
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27 |
1 |
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artikel
|
| 24 |
Innovative Approaches in Regulatory Affairs: Leveraging Artificial Intelligence and Machine Learning for Efficient Compliance and Decision-Making
|
Ajmal, C. S.
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27 |
1 |
|
artikel
|
| 25 |
Interference of Plasticizers on Plasma Protein Binding Measurements
|
Harrison, Makayla
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27 |
1 |
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artikel
|
| 26 |
Mechanistic Approach into 1,2,3-triazoles-based IIIM(S)-RS98 Mediated Apoptosis in Lung Cancer Cells
|
Dolkar, Rigzin
|
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27 |
1 |
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artikel
|
| 27 |
Meta-Analysis of the Input and Disposition of Various Dosage Forms of Methylprednisolone in Healthy Subjects Utilizing a Physiologically Based Pharmacokinetic Model
|
Yu, Ruihong
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27 |
1 |
|
artikel
|
| 28 |
Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies
|
Gupta, Sana
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27 |
1 |
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artikel
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| 29 |
Pharmaceutical Sciences: Insights and Observations from Academic Chairs and Vice Chairs
|
Ainslie, Kristy M.
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27 |
1 |
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artikel
|
| 30 |
Pharmacokinetic-pharmacodynamic Modelling of NH600001 in Healthy Subjects and Patients Undergoing Gastroscopy
|
Liu, Yaxin
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27 |
1 |
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artikel
|
| 31 |
PK/PD Evaluation of Antibody–Drug Conjugates with Enhanced Immune Effector Functions
|
Chang, Hsuan-Ping
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27 |
1 |
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artikel
|
| 32 |
Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRASG12C Mutation from Phase 1 and Phase 2 Studies
|
Nagase, Mario
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27 |
1 |
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artikel
|
| 33 |
Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab
|
Jang, Dawon
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27 |
1 |
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artikel
|
| 34 |
Precision Nanomedicine: Lapatinib-Loaded Chitosan-Gold Nanoparticles Targeting LINC01615 for Lung Cancer Therapy
|
Rezaei Aghdam, Hadi
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|
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27 |
1 |
|
artikel
|
| 35 |
Prediction of Area Under the Curve from Urinary Vancomycin Concentrations Measured Using a Simple Method
|
Oshima, Yuki
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27 |
1 |
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artikel
|
| 36 |
Prediction of Drug-Drug Interactions for Highly Plasma Protein Bound Compounds
|
Tess, David
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27 |
1 |
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artikel
|
| 37 |
Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation
|
Zhong, Hao
|
|
|
27 |
1 |
|
artikel
|
| 38 |
Quantitative Comparison and Clustering of Circular Dichroism Spectra Using a Symmetrized Weighted Spectral Difference
|
Chouchane, Karim
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27 |
1 |
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artikel
|
| 39 |
Recommendation for Clarifying FDA Policy in Evaluating “Sameness” of Higher Order Structure for Generic Peptide Therapeutics
|
Rogers-Crovak, Jessica A.
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27 |
1 |
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artikel
|
| 40 |
Reformation of a Clinical Anti-Drug Antibody Assay to Enable the Immunogenicity Assessment of a Bispecific Antibody Biotherapeutic
|
Liu, Wenyu
|
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27 |
1 |
|
artikel
|
| 41 |
Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient
|
Orr, Robert K.
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27 |
1 |
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artikel
|
| 42 |
Rejoinder to the ‘Letter to the Editor’ on “Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies”
|
Schütz, Helmut
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27 |
1 |
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artikel
|
| 43 |
Simultaneous Quantification of Total Antibody and Conjugated Payload for DS001 in Rat Serum Using a Hybrid Immuno-Capture LC–MS/MS
|
Yu, Xiong
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27 |
1 |
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artikel
|
| 44 |
Stability of Anti-Drug Antibodies Against Antibody Therapeutics
|
Sirohi, Parul
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27 |
1 |
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artikel
|
| 45 |
Tumor-Infiltration Mimicking Model of Contaminated Ovarian Tissue as an Innovative Platform for Advanced Cancer Research
|
Moghassemi, Saeid
|
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|
27 |
1 |
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artikel
|
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