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 |
|
|
27 |
1 |
|
artikel |
2 |
A Highly Sensitive Immunoassay to Enable Quantification of a Nanobody-Based Imaging Agent in Human Serum
|
Guelman, Sebastian |
|
|
27 |
1 |
|
artikel |
3 |
Analysis on the Impact of U.S. FDA’s Narrow Therapeutic Index Bioequivalence Criteria on Generic Drug Applications
|
Anim Anno, Krista |
|
|
27 |
1 |
|
artikel |
4 |
Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy
|
Abduljalil, Khaled |
|
|
27 |
1 |
|
artikel |
5 |
Bioanalytical Method Comparison Strategy for Clinical Anti-drug Antibody Immunoassays
|
Elliott, R. J. |
|
|
27 |
1 |
|
artikel |
6 |
Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder
|
Santos Gomes, Bernardo Filipe |
|
|
27 |
1 |
|
artikel |
7 |
Cell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin
|
Her, Cheng |
|
|
27 |
1 |
|
artikel |
8 |
Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials
|
Lai, Ching-Ha |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
artikel |
10 |
Correction: Assessing Immunogenicity in Drug Reviews and Prescribing Information in Japan
|
Ishibai, Mitsuru |
|
|
27 |
1 |
|
artikel |
11 |
Correction: Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation
|
Zhong, Hao |
|
|
27 |
1 |
|
artikel |
12 |
Correction: Tumor-Targeted Chemoimmunotherapy with Immune-Checkpoint Blockade for Enhanced Anti-Melanoma Efficacy
|
Li, Man |
|
|
27 |
1 |
|
artikel |
13 |
Development of a PBPK Model for Lamotrigine which Incorporates Metabolism by UGT2B10: Impact of UGT2B10 Poor Metabolizer Phenotype and Pregnancy
|
Gardner, Iain |
|
|
27 |
1 |
|
artikel |
14 |
Development of Solidified Self-microemulsifying Delivery Systems Containing Tacrolimus for Enhanced Dissolution and Pharmacokinetic Profile
|
Zeng, Lingjun |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
artikel |
16 |
Evaluating the Immunogenicity Risk of Protein Therapeutics by Augmenting T Cell Epitope Prediction with Clinical Factors
|
Hu, Zicheng |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
artikel |
18 |
Exploring the Correlation between LC–MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis
|
Jiang, Tingting |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
artikel |
21 |
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent
|
Hernández, Magali |
|
|
27 |
1 |
|
artikel |
22 |
Impact of Dapagliflozin on Hepatic Lipid Metabolism and a Dynamic Model of Ketone Body Levels
|
Wan, Zhijie |
|
|
27 |
1 |
|
artikel |
23 |
Impact of Weak Vibration Generated by a Refrigerator on Protein Aggregation
|
Kizuki, Shinji |
|
|
27 |
1 |
|
artikel |
24 |
Innovative Approaches in Regulatory Affairs: Leveraging Artificial Intelligence and Machine Learning for Efficient Compliance and Decision-Making
|
Ajmal, C. S. |
|
|
27 |
1 |
|
artikel |
25 |
Interference of Plasticizers on Plasma Protein Binding Measurements
|
Harrison, Makayla |
|
|
27 |
1 |
|
artikel |
26 |
Mechanistic Approach into 1,2,3-triazoles-based IIIM(S)-RS98 Mediated Apoptosis in Lung Cancer Cells
|
Dolkar, Rigzin |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
artikel |
28 |
Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies
|
Gupta, Sana |
|
|
27 |
1 |
|
artikel |
29 |
Pharmaceutical Sciences: Insights and Observations from Academic Chairs and Vice Chairs
|
Ainslie, Kristy M. |
|
|
27 |
1 |
|
artikel |
30 |
Pharmacokinetic-pharmacodynamic Modelling of NH600001 in Healthy Subjects and Patients Undergoing Gastroscopy
|
Liu, Yaxin |
|
|
27 |
1 |
|
artikel |
31 |
PK/PD Evaluation of Antibody–Drug Conjugates with Enhanced Immune Effector Functions
|
Chang, Hsuan-Ping |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
artikel |
34 |
Precision Nanomedicine: Lapatinib-Loaded Chitosan-Gold Nanoparticles Targeting LINC01615 for Lung Cancer Therapy
|
Rezaei Aghdam, Hadi |
|
|
27 |
1 |
|
artikel |
35 |
Prediction of Area Under the Curve from Urinary Vancomycin Concentrations Measured Using a Simple Method
|
Oshima, Yuki |
|
|
27 |
1 |
|
artikel |
36 |
Prediction of Drug-Drug Interactions for Highly Plasma Protein Bound Compounds
|
Tess, David |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
artikel |
39 |
Recommendation for Clarifying FDA Policy in Evaluating “Sameness” of Higher Order Structure for Generic Peptide Therapeutics
|
Rogers-Crovak, Jessica A. |
|
|
27 |
1 |
|
artikel |
40 |
Reformation of a Clinical Anti-Drug Antibody Assay to Enable the Immunogenicity Assessment of a Bispecific Antibody Biotherapeutic
|
Liu, Wenyu |
|
|
27 |
1 |
|
artikel |
41 |
Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient
|
Orr, Robert K. |
|
|
27 |
1 |
|
artikel |
42 |
Rejoinder to the ‘Letter to the Editor’ on “Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies”
|
Schütz, Helmut |
|
|
27 |
1 |
|
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 |
|
|
27 |
1 |
|
artikel |
44 |
Stability of Anti-Drug Antibodies Against Antibody Therapeutics
|
Sirohi, Parul |
|
|
27 |
1 |
|
artikel |
45 |
Tumor-Infiltration Mimicking Model of Contaminated Ovarian Tissue as an Innovative Platform for Advanced Cancer Research
|
Moghassemi, Saeid |
|
|
27 |
1 |
|
artikel |