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The AAPS Journal
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Volume 21, Issue 5, September 2019
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1. Correction to: Metabolic Profile of 3-Acetyl-11-Keto-β-Boswellic Acid and 11-Keto-β-Boswellic Acid in Human Preparations In Vitro, Species Differences, and Bioactivity Variation
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Tác giả
Yonglei Cui, Xiangge Tian, Jing Ning, Chao Wang, Zhenlong Yu, Yan Wang.
2. Reconciling Human-Canine Differences in Oral Bioavailability: Looking beyond the Biopharmaceutics Classification System
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Tác giả
Marilyn N. Martinez, Ayman El-Kattan, Elias Awji, Mark Papich.
3. Cellular Uptake and Distribution of Gemini Surfactant Nanoparticles Used as Gene Delivery Agents
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Tác giả
Wei Jin, Mays Al-Dulaymi, Ildiko Badea, Scot C. Leary, Jeveria Rehman.
4. Evaluation of Assumptions Underpinning Pharmacometric Models
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Tác giả
Qing-Xi Ooi, Daniel F. B. Wright, Geoffrey K. Isbister.
5. TCPro: an In Silico Risk Assessment Tool for Biotherapeutic Protein Immunogenicity
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Tác giả
Osman N. Yogurtcu, Zuben E. Sauna, Joseph R. McGill, Million A. Tegenge
6. Optimizing Dose-Finding Studies for Drug Combinations Based on Exposure-Response Models
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Tác giả
Theodoros Papathanasiou, Anders Strathe, Rune Viig Overgaard.
7. Evaluating a Multiscale Mechanistic Model of the Immune System to Predict Human Immunogenicity for a Biotherapeutic in Phase 1
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Tác giả
Lora Hamuro, Giridhar S. Tirucherai, Sean M. Crawford, Akbar Nayeem.
8. Modeling Combined Anti-Inflammatory Effects of Dexamethasone and Tofacitinib in Arthritic Rats
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Tác giả
Ruihong Yu, Dawei Song, Debra C DuBois, Richard R. Almon.
9. A Fit-for-Purpose Method for the Detection of Human Antibodies to Surface-Exposed Components of BMS-986263, a Lipid Nanoparticle-Based Drug Product Containing a siRNA Drug Substance
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Tác giả
Uma Kavita, Wendy Miller, Qin C. Ji, Renuka C. Pillutla.
10. Model-Informed Drug Development Approach Supporting Approval of Adalimumab (HUMIRA) in Adolescent Patients with Hidradenitis Suppurativa: a Regulatory Perspective
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Tác giả
Youwei Bi, Jiang Liu, Jie Wang, Roselyn E. Epps, David Kettl.
11. Reduced Systemic and Brain Exposure with Inhibited Liver Metabolism of Carbamazepine After Its Long-Term Combination Treatment with Piperine for Epilepsy Control in Rats
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Tác giả
Tianjing Ren, Min Xiao, Mengbi Yang, Jiajia Zhao, Yufeng Zhang.
12. Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift
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Tác giả
Mitra Azadeh, Perceval Sondag, Ying Wang, Maribeth Raines.
13. Optimized Renal Transporter Quantification by Using Aquaporin 1 and Aquaporin 2 as Anatomical Markers: Application in Characterizing the Ontogeny of Renal Transporters and Its Correlation with Hepatic Transporters in Paired Human Samples
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Tác giả
Cindy Yanfei Li, Chelsea Hosey-Cojocari, Abdul Basit.
14. Compensated Hydroxyl Radical Protein Footprinting Measures Buffer and Excipient Effects on Conformation and Aggregation in an Adalimumab Biosimilar
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Tác giả
Sandeep K. Misra, Ron Orlando, Scot R. Weinberger, Joshua S. Sharp.
15. A Tangeretin Derivative Inhibits the Growth of Human Prostate Cancer LNCaP Cells by Epigenetically Restoring p21 Gene Expression and Inhibiting Cancer Stem-like Cell Proliferation
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Tác giả
Guor-Jien Wei, Yen-Hsiang Chao, Yen-Chen Tung, Tien-Yuan Wu.
16. Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies
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Tác giả
Ari Brekkan, Luis Lopez-Lazaro, Elodie L. Plan, Joakim Nyberg.
17. Characterization and Quantification of an Fc-FGF21 Fusion Protein in Rat Serum Using Immunoaffinity LC-MS
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Tác giả
Fengping Li, Yan Weng, Guodong Zhang, Xiaogang Han, Dongmei Li.
18. Anthocyanin Delphinidin Prevents Neoplastic Transformation of Mouse Skin JB6 P+ Cells: Epigenetic Re-activation of Nrf2-ARE Pathway
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Tác giả
Hsiao-Chen Dina Kuo, Renyi Wu, Shanyi Li, Anne Yuqing Yang, Ah-Ng Kong.
19. Determination of IL-23 Pharmacokinetics by Highly Sensitive Accelerator Mass Spectrometry and Subsequent Modeling to Project IL-23 Suppression in Psoriasis Patients Treated with Anti-IL-23 Antibodies
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Tác giả
Ting-Ting Zhang, Junli Ma, Kenneth R. Durbin, Timothy Montavon.
20. A Pediatric Covariate Function for CYP3A-Mediated Midazolam Clearance Can Scale Clearance of Selected CYP3A Substrates in Children
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Tác giả
Janneke M. Brussee, Elke H. J. Krekels, Elisa A. M. Calvier.
21. Population Pharmacokinetics and Pharmacodynamics of Apixaban Linking Its Plasma Concentration to Intrinsic Activated Coagulation Factor X Activity in Japanese Patients with Atrial Fibrillation
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Tác giả
Satoshi Ueshima, Daiki Hira, Chiho Tomitsuka, Miki Nomura, Yuuma Kimura.
22. A Computational Model of Neoadjuvant PD-1 Inhibition in Non-Small Cell Lung Cancer
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Tác giả
Mohammad Jafarnejad, Chang Gong, Edward Gabrielson, Imke H. Bartelink.
23. Guidance for Rifampin and Midazolam Dosing Protocols To Study Intestinal and Hepatic Cytochrome P450 (CYP) 3A4 Induction and De-induction
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Tác giả
Asha J Kapetas, Michael J Sorich, A David Rodrigues, Andrew Rowland.
24. Impact of Intracellular Concentrations on Metabolic Drug-Drug Interaction Studies
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Tác giả
Andrea Treyer, Mohammed Ullah, Neil Parrott, Birgit Molitor.
25. Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis
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Tác giả
Boris Gorovits, Marcela Araya Roldan, Daniel Baltrukonis, Chun-Hua Cai.
