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                             45 gevonden resultaten
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
                             45 gevonden resultaten
 
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