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Model-Informed Drug Development Approach Supporting Approval of Adalimumab (HUMIRA) in Adolescent Patients with Hidradenitis Suppurativa: a Regulatory Perspective Youwei BiJiang LiuYaning Wang Regulatory Note 19 July 2019 Article: 91
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Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift Mitra AzadehPerceval SondagJeffrey Sailstad White Paper Open access 11 July 2019 Article: 89
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 Cindy Yanfei LiChelsea Hosey-CojocariBhagwat Prasad Research Article 11 July 2019 Article: 88
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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 Guor-Jien WeiYen-Hsiang ChaoZheng-Yuan Su Research Article 10 July 2019 Article: 86
Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies Ari BrekkanLuis Lopez-LazaroMats O. Karlsson Research Article Open access 08 July 2019 Article: 85
Characterization and Quantification of an Fc-FGF21 Fusion Protein in Rat Serum Using Immunoaffinity LC-MS Fengping LiYan WengHendrik Neubert Research Article 08 July 2019 Article: 84
Anthocyanin Delphinidin Prevents Neoplastic Transformation of Mouse Skin JB6 P+ Cells: Epigenetic Re-activation of Nrf2-ARE Pathway Hsiao-Chen Dina KuoRenyi WuAh-Ng Kong Research Article 28 June 2019 Article: 83
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 Ting-Ting ZhangJunli MaJ. Cory Kalvass Research Article 27 June 2019 Article: 82
A Pediatric Covariate Function for CYP3A-Mediated Midazolam Clearance Can Scale Clearance of Selected CYP3A Substrates in Children Janneke M. BrusseeElke H. J. KrekelsCatherijne A. J. Knibbe Research Article Open access 27 June 2019 Article: 81
Population Pharmacokinetics and Pharmacodynamics of Apixaban Linking Its Plasma Concentration to Intrinsic Activated Coagulation Factor X Activity in Japanese Patients with Atrial Fibrillation Satoshi UeshimaDaiki HiraToshiya Katsura Research Article 24 June 2019 Article: 80
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Guidance for Rifampin and Midazolam Dosing Protocols To Study Intestinal and Hepatic Cytochrome P450 (CYP) 3A4 Induction and De-induction Asha J KapetasMichael J SorichAndrew Rowland Research Article 19 June 2019 Article: 78
Impact of Intracellular Concentrations on Metabolic Drug-Drug Interaction Studies Andrea TreyerMohammed UllahPer Artursson Research Article Open access 18 June 2019 Article: 77
Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis Boris GorovitsMarcela Araya RoldanYing Wang Research Article 18 June 2019 Article: 76