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A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA’s Benefit-Risk Framework Jane Namangolwa MutangaUjwani NukalaHong Yang Meeting Report 09 February 2023 Article: 24
Best Practices in mAb and Soluble Target Assay Selection for Quantitative Modelling and Qualitative Interpretation David FairmanHuaping Tang Commentary 09 February 2023 Article: 23
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine Cole J. BattyLiubov M. LifshitsKristy M. Ainslie Research Article 31 January 2023 Article: 22
The Development and Characterization of a Highly Sensitive Mature TGFβ3 Assay to Evaluate Anti-TGFβ3 Target Engagement A. Francesca SetiadiGizette SperindeSaloumeh K. Fischer Research Article 26 January 2023 Article: 21
Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions Avery BelenosErin Leigh WoodAdam C. Fisher Review Article Open access 26 January 2023 Article: 20
Theoretical Examination Seeking Tangible Physical Meanings of Slopes and Intercepts of Plasma Concentration–Time Relationships in Minimal Physiologically Based Pharmacokinetic Models Yoo-Seong JeongWilliam J. Jusko Research Article 26 January 2023 Article: 19
A Novel Neutralization Antibody Assay Method to Overcome Drug Interference with Better Compatibility with Acid-Sensitive Neutralizing Antibodies Dilki WickramarachchiJulianne WagnerWeifeng Xu Research Article 25 January 2023 Article: 18
Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs Kang ChenCameron J. Smith Regulatory Note 20 January 2023 Article: 17
Model-Informed Approach Supporting Approval of Nexviazyme (Avalglucosidase Alfa-ngpt) in Pediatric Patients with Late-Onset Pompe Disease Ruo-Jing LiLian MaMichael Pacanowski Regulatory Note 18 January 2023 Article: 16
Correction: End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics Annette Medina MoralesAlavattam SreedharaShubhadra Singh Correction 11 January 2023 Article: 15
Lessons from CDER’s Quality Management Maturity Pilot Programs Jennifer MaguireAdam FisherMichael Kopcha Commentary Open access 10 January 2023 Article: 14
Pancreatic Hormone Insulin Modulates Organic Anion Transporter 1 in the Kidney: Regulation via Remote Sensing and Signaling Network Zhou YuJinghui ZhangGuofeng You Research Article 10 January 2023 Article: 13
Development and Validation of a Western Blot Method to Quantify Mini-Dystrophin in Human Skeletal Muscle Biopsies Catherine I. SoderstromJennifer LarsenMohamed Hassanein Research Article Open access 20 December 2022 Article: 12
Challenges and Strategies for Solubility Measurements and Dissolution Method Development for Amorphous Solid Dispersion Formulations Andre HermansJohanna MilsmannMichael Cohen White Paper Open access 13 December 2022 Article: 11
Overcoming Biopharmaceutical Interferents for Quantitation of Host Cell DNA Using an Automated, High-Throughput Methodology Mackenzie L. LauroAmy M. BowmanJohn W. Loughney Research Article 08 December 2022 Article: 10
Development of a Near-Infrared Spectroscopy (NIRS)–Based Characterization Approach for Inherent Powder Blend Heterogeneity in Direct Compression Formulations Zhenqi ShiKallakuri Suparna RaoChen Mao Research Article 08 December 2022 Article: 9
Stability and Function of Extracellular Vesicles Derived from Immortalized Human Corneal Stromal Stem Cells: A Proof of Concept Study Ning LyuRobert KnightSophie X. Deng Research Article Open access 05 December 2022 Article: 8
Addressing the Accuracy of Plasma Protein Binding Measurement for Highly Bound Compounds Using the Dilution Method Sangwoo RyuDavid TessLi Di Brief/Technical Note 05 December 2022 Article: 7
End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics Annette Medina MoralesAlavattam SreedharaShubhadra Singh Commentary 05 December 2022 Article: 6
Monoclonal Antibody Pharmacokinetics in Cynomolgus Monkeys Following Subcutaneous Administration: Physiologically Based Model Predictions from Physiochemical Properties Shihao HuAmita Datta-MannanDavid Z. D’Argenio Research Article 01 December 2022 Article: 5
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review Vy Thi Thanh NguyenNicolas DarvilleAn Vermeulen Review Article 01 December 2022 Article: 4
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 Ruth FrenkelDana TribbyBernice Yeung Research Article Open access 22 November 2022 Article: 3
Preclinical Observations of Systemic and Ocular Antidrug Antibody Response to Intravitreally Administered Drugs Uwe WesselsMarkus ZadakKay-Gunnar Stubenrauch Research Article Open access 22 November 2022 Article: 2
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