Biowaiver Applications in Support of a Polymorph During Late-Stage Clinical Development of Verubecestat—Current Challenges and Future Opportunities for Global Regulatory Alignment Andreas AbendLeah XiongPramod Kotwal Research Article 20 December 2019 Article: 17
Impact of Interleukin-6 on Drug-Metabolizing Enzymes and Transporters in Intestinal Cells Florian SimonJessica GarciaLéa Payen Research Article 20 December 2019 Article: 16
Current Perspectives on Ligand-Binding Assay Practices in the Quantification of Circulating Therapeutic Proteins for Biosimilar Biological Product Development T. M. ThwayY. M. WangI. Zineh Regulatory Note 19 December 2019 Article: 15
Structural Characterization of the Aurora Kinase B “DFG-flip” Using Metadynamics Naga Rajiv LakkanigaMeenakshisundaram BalasubramaniamHong-yu Li Research Article 18 December 2019 Article: 14
Biotransformation of the New Synthetic Cannabinoid with an Alkene, MDMB-4en-PINACA, by Human Hepatocytes, Human Liver Microsomes, and Human Urine and Blood Shimpei WatanabeSvante VikingssonRobert Kronstrand Research Article 17 December 2019 Article: 13
A Systems Pharmacology Model for Drug Delivery to Solid Tumors by Antibody-Drug Conjugates: Implications for Bystander Effects Jackson K. BurtonDean BottinoTimothy W. Secomb Research Article 11 December 2019 Article: 12
An Investigation into the Factors Governing Drug Absorption and Food Effect Prediction Based on Data Mining Methodology Biljana GatarićJelena Parojčić Research Article 10 December 2019 Article: 11
AAPS Workshop Report on ICH M10 Brian BoothFaye VazvaeiEric Woolf Meeting Report Open access 10 December 2019 Article: 10
Deconvolution Analysis by Non-linear Regression Using a Convolution-Based Model: Comparison of Nonparametric and Parametric Approaches Roberto GomeniFrançoise Bressolle-Gomeni Research Article 09 December 2019 Article: 9
Epigenome and transcriptome study of moringa isothiocyanate in mouse kidney mesangial cells induced by high glucose, a potential model for diabetic-induced nephropathy Shanyi LiWenji LiAh-Ng Kong Research Article 05 December 2019 Article: 8
Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs Francesca CivoliAparna KasinathTodd Lester White Paper 02 December 2019 Article: 7
On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants: an Exploratory Study Highlighting the Importance of Infant Food Marina StatelovaKonstantinos GoumasMaria Vertzoni Research Article 02 December 2019 Article: 6
Reengineering of Albumin-Fused Cocaine Hydrolase CocH1 (TV-1380) to Prolong Its Biological Half-Life Yingting CaiShuo ZhouFang Zheng Research Article 21 November 2019 Article: 5
Application of Item Response Theory to Model Disease Progression and Agomelatine Effect in Patients with Major Depressive Disorder Marc CerouSophie PeignéMarylore Chenel Research Article 12 November 2019 Article: 4
Mechanistic Deconvolution of Oral Absorption Model with Dynamic Gastrointestinal Fluid to Predict Regional Rate and Extent of GI Drug Dissolution Alex YuMark J. KoenigsknechtDuxin Sun Research Article 11 November 2019 Article: 3
Analysis of the Regulatory Divergence of Comparative Dissolution Requirements for Post-Approval Manufacturing Changes of Modified Release Solid Oral Dosage Forms Connie LangerDorys Argelia DiazStephen Colgan Research Article 04 November 2019 Article: 2
Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle Roman MathaesLinda NarhiDean Ripple White Paper 30 October 2019 Article: 1