| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
ACUVRA: Anion-Exchange Chromatography UV-Ratio Analysis—A QC-Friendly Method for Monitoring Adeno-Associated Virus Empty Capsid Content To Support Process Development and GMP Release Testing
|
Frenkel, Ruth
|
|
|
25 |
1 |
|
artikel
|
| 2 |
Addressing the Accuracy of Plasma Protein Binding Measurement for Highly Bound Compounds Using the Dilution Method
|
Ryu, Sangwoo
|
|
|
25 |
1 |
|
artikel
|
| 3 |
A Novel Neutralization Antibody Assay Method to Overcome Drug Interference with Better Compatibility with Acid-Sensitive Neutralizing Antibodies
|
Wickramarachchi, Dilki
|
|
|
25 |
1 |
|
artikel
|
| 4 |
A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA’s Benefit-Risk Framework
|
Mutanga, Jane Namangolwa
|
|
|
25 |
1 |
|
artikel
|
| 5 |
A Simple One-Parameter Percent Dissolved Versus Time Dissolution Equation that Accommodates Sink and Non-sink Conditions via Drug Solubility and Dissolution Volume
|
Polli, James E.
|
|
|
25 |
1 |
|
artikel
|
| 6 |
Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs
|
Chen, Kang
|
|
|
25 |
1 |
|
artikel
|
| 7 |
Best Practices in mAb and Soluble Target Assay Selection for Quantitative Modelling and Qualitative Interpretation
|
Fairman, David
|
|
|
25 |
1 |
|
artikel
|
| 8 |
Challenges and Strategies for Solubility Measurements and Dissolution Method Development for Amorphous Solid Dispersion Formulations
|
Hermans, Andre
|
|
|
25 |
1 |
|
artikel
|
| 9 |
Correction: End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics
|
Morales, Annette Medina
|
|
|
25 |
1 |
|
artikel
|
| 10 |
Development and Validation of a Western Blot Method to Quantify Mini-Dystrophin in Human Skeletal Muscle Biopsies
|
Soderstrom, Catherine I.
|
|
|
25 |
1 |
|
artikel
|
| 11 |
Development of a Near-Infrared Spectroscopy (NIRS)–Based Characterization Approach for Inherent Powder Blend Heterogeneity in Direct Compression Formulations
|
Shi, Zhenqi
|
|
|
25 |
1 |
|
artikel
|
| 12 |
End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics
|
Morales, Annette Medina
|
|
|
25 |
1 |
|
artikel
|
| 13 |
Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039
|
Kourentas, Alexandros
|
|
|
25 |
1 |
|
artikel
|
| 14 |
Lessons from CDER’s Quality Management Maturity Pilot Programs
|
Maguire, Jennifer
|
|
|
25 |
1 |
|
artikel
|
| 15 |
Model-Informed Approach Supporting Approval of Nexviazyme (Avalglucosidase Alfa-ngpt) in Pediatric Patients with Late-Onset Pompe Disease
|
Li, Ruo-Jing
|
|
|
25 |
1 |
|
artikel
|
| 16 |
Monoclonal Antibody Pharmacokinetics in Cynomolgus Monkeys Following Subcutaneous Administration: Physiologically Based Model Predictions from Physiochemical Properties
|
Hu, Shihao
|
|
|
25 |
1 |
|
artikel
|
| 17 |
Overcoming Biopharmaceutical Interferents for Quantitation of Host Cell DNA Using an Automated, High-Throughput Methodology
|
Lauro, Mackenzie L.
|
|
|
25 |
1 |
|
artikel
|
| 18 |
Pancreatic Hormone Insulin Modulates Organic Anion Transporter 1 in the Kidney: Regulation via Remote Sensing and Signaling Network
|
Yu, Zhou
|
|
|
25 |
1 |
|
artikel
|
| 19 |
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review
|
Nguyen, Vy Thi Thanh
|
|
|
25 |
1 |
|
artikel
|
| 20 |
Preclinical Observations of Systemic and Ocular Antidrug Antibody Response to Intravitreally Administered Drugs
|
Wessels, Uwe
|
|
|
25 |
1 |
|
artikel
|
| 21 |
Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions
|
Belenos, Avery
|
|
|
25 |
1 |
|
artikel
|
| 22 |
Stability and Function of Extracellular Vesicles Derived from Immortalized Human Corneal Stromal Stem Cells: A Proof of Concept Study
|
Lyu, Ning
|
|
|
25 |
1 |
|
artikel
|
| 23 |
The Development and Characterization of a Highly Sensitive Mature TGFβ3 Assay to Evaluate Anti-TGFβ3 Target Engagement
|
Setiadi, A. Francesca
|
|
|
25 |
1 |
|
artikel
|
| 24 |
Theoretical Examination Seeking Tangible Physical Meanings of Slopes and Intercepts of Plasma Concentration–Time Relationships in Minimal Physiologically Based Pharmacokinetic Models
|
Jeong, Yoo-Seong
|
|
|
25 |
1 |
|
artikel
|
| 25 |
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine
|
Batty, Cole J.
|
|
|
25 |
1 |
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artikel
|
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