Changes in Individual Drug-Independent System Parameters during Virtual Paediatric Pharmacokinetic Trials: Introducing Time-Varying Physiology into a Paediatric PBPK Model Journal title: The AAPS Journal Authors: Khaled Abduljalil, Masoud Jamei, Amin Rostami-Hodjegan, Trevor N. Johnson Subject(s): Medicine
A White Paper—Consensus and Recommendations of a Global Harmonization Team on Assessing the Impact of Immunogenicity on Pharmacokinetic Measurements Journal title: The AAPS Journal Authors: J. M. Sailstad, L. Amaravadi, A. Clements-Egan, B. Gorovits, H. A. Myler, R. C. Pillutla, S. Pursuho... Subject(s): Medicine
Practical Considerations for Dose Selection in Pediatric Patients to Ensure Target Exposure Requirements Journal title: The AAPS Journal Authors: April M. Barbour, Michael J. Fossler, Jeffrey Barrett Subject(s): Medicine
When Assay Format Matters: a Case Study on the Evaluation of Three Assay Formats to Support a Clinical Pharmacokinetic Study Journal title: The AAPS Journal Authors: Kun Peng, Dana Baker, Suzanne Brignoli, Janis Cabuhat, Saloumeh K. Fischer Subject(s): Medicine
Mechanism-Based Pharmacokinetic Modeling to Evaluate Transporter-Enzyme Interplay in Drug Interactions and Pharmacogenetics of Glyburide Journal title: The AAPS Journal Authors: Manthena V. S. Varma, Renato J. Scialis, Jian Lin, Yi-An Bi, Charles J. Rotter, Theunis C. Goosen, X... Subject(s): Medicine
Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments Journal title: The AAPS Journal Authors: Joseph C. Marini, Michael Anderson, Xiao-Yan Cai, John Chappell, Todd Coffey, Dominique Gouty, Aparn... Subject(s): Medicine
Similarities and Differences in Gastrointestinal Physiology Between Neonates and Adults: a Physiologically Based Pharmacokinetic Modeling Perspective Journal title: The AAPS Journal Authors: Guo Yu, Qing-Shan Zheng, Guo-Fu Li Subject(s): Medicine
Population Pharmacokinetic/Pharmacodynamic Modeling of Guanfacine Effects on QTc and Heart Rate in Pediatric Patients Journal title: The AAPS Journal Authors: William Knebel, James Ermer, Jaideep Purkayastha, Patrick Martin, Marc R. Gastonguay Subject(s): Medicine
Reliability and Extension of Quantitative Prediction of CYP3A4-Mediated Drug Interactions Based on Clinical Data Journal title: The AAPS Journal Authors: Constance Loue, Michel Tod Subject(s): Medicine
Elucidation of Arctigenin Pharmacokinetics After Intravenous and Oral Administrations in Rats: Integration of In Vitro and In Vivo Findings via Semi-mechanistic Pharmacokinetic Modeling Journal title: The AAPS Journal Authors: Qiong Gao, Yufeng Zhang, Siukwan Wo, Zhong Zuo Subject(s): Medicine
Evaluation of Acoustic Membrane Microparticle (AMMP) Technology for a Sensitive Ligand Binding Assay to Support Pharmacokinetic Determinations of a Biotherapeutic Journal title: The AAPS Journal Authors: Shannon D. Chilewski, W. Matthew Dickerson, Johanna R. Mora, Ashley Saab, Edward M. Alderman Subject(s): Medicine
Study Reanalysis Using a Mechanism-Based Pharmacokinetic/Pharmacodynamic Model of Pramlintide in Subjects with Type 1 Diabetes Journal title: The AAPS Journal Authors: Jing Fang, Cornelia B. Landersdorfer, Brenda Cirincione, William J. Jusko Subject(s): Medicine
Stratification of Antibody-Positive Subjects by Antibody Level Reveals an Impact of Immunogenicity on Pharmacokinetics Journal title: The AAPS Journal Authors: Lei Zhou, Sarah A. Hoofring, Yu Wu, Thuy Vu, Peiming Ma, Steven J. Swanson, Narendra Chirmule, Marta... Subject(s): Medicine
Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes Journal title: The AAPS Journal Authors: Ramak Pourvasei, Ed Lee, Michael Eschenberg, Vimal Patel, Chris Macaraeg, Kinnari Pandya, Judy Shih,... Subject(s): Medicine
A Pharmacokinetic Simulation Tool for Inhaled Corticosteroids Journal title: The AAPS Journal Authors: Benjamin Weber, Guenther Hochhaus Subject(s): Medicine
