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volume 26, number 4, 2024

Mélanie Guhl, Julie Bertrand, Lucie Fayette, Francois Mercier, Emmanuelle Comets
Correction: Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models-a New Method Based on Metropolis-Hastings Algorithm. The AAPS journal 26 (4) (2024)
Niels Hendrickx, France Mentré, Andreas Traschütz, Cynthia Gagnon, Rebecca Schüle, null null, null null, Matthis Synofzik, Emmanuelle Comets
Correction: Prediction of Individual Disease Progression Including Parameter Uncertainty in Rare Neurodegenerative Diseases: The Example of Autosomal-Recessive Spastic Ataxia Charlevoix Saguenay (ARSACS). The AAPS journal 26 (4) (2024)
Anna Kopp, Jiakun Guan, Colette Johnston, Steven Vance, James Legg, Laurie Galson-Holt, Greg M Thurber
Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents. The AAPS journal 26 (4) (2024)
Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Laura Schild Hay, Bethany Ward, Luke Armstrong, Mitra Azadeh, Liching Cao, Rebecca Carmean, Jason DelCarpini, Sanjay L Dholakiya, Amanda Hays, Sarah Hosback, Zheng Hu, Nadia Kulagina, Seema Kumar, Ching Ha Lai, Marit Lichtfuss, Hsing-Yin Liu, Susana Liu, Reza Mozaffari, Luying Pan, Jason Pennucci, Marie-Eve Poupart, Gurleen Saini, Veerle Snoeck, Kristine Storey, Amy Turner, Inna Vainshtein, Daniela Verthelyi, Iwona Wala, Lili Yang, Lin Yang
Neutralizing Antibody Sample Testing and Report Harmonization. The AAPS journal 26 (4) (2024)
Innocent Gerald Asiimwe, Bonginkosi S'fiso Ndzamba, Samer Mouksassi, Goonaseelan 'Colin' Pillai, Aurélie Lombard, Jennifer Lang
Machine-Learning Assisted Screening of Correlated Covariates: Application to Clinical Data of Desipramine. The AAPS journal 26 (4) (2024)
John P Prybylski, Yuchen Wang, Vaishali Sahasrabudhe, Vivek Purohit
Simulating Healthy Participant Pharmacokinetics for Renal and Hepatic Impairment Studies: Retrospective Assessment of the Approach. The AAPS journal 26 (4) (2024)
Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Laura Schild Hay, Bethany Ward, Luke Armstrong, Mitra Azadeh, Liching Cao, Rebecca Carmean, Jason DelCarpini, Sanjay L Dholakiya, Amanda Hays, Sarah Hosback, Zheng Hu, Nadia Kulagina, Seema Kumar, Ching Ha Lai, Marit Lichtfuss, Hsing-Yin Liu, Susana Liu, Reza Mozaffari, Luying Pan, Jason Pennucci, Marie-Eve Poupart, Gurleen Saini, Veerle Snoeck, Kristine Storey, Amy Turner, Inna Vainshtein, Daniela Verthelyi, Iwona Wala, Lili Yang, Lin Yang
Neutralizing Antibody Sample Testing and Report Harmonization. The AAPS journal 26 (4) (2024)
Min-Soo Kim, Dagmar M Hajducek, James C Gilbert, Alfonso Iorio, Bernd Jilma, Andrea N Edginton
Kinetic Modeling for BT200 to Predict the Level of Plasma-Derived Coagulation Factor VIII in Humans. The AAPS journal 26 (4) (2024)
Min-Soo Kim, Dagmar M Hajducek, James C Gilbert, Alfonso Iorio, Bernd Jilma, Andrea N Edginton
Kinetic Modeling for BT200 to Predict the Level of Plasma-Derived Coagulation Factor VIII in Humans. The AAPS journal 26 (4) (2024)
Lian Xu, Sanwang Li, Wei Wu, Zeneng Cheng, Feifan Xie
Sample Size Determination and Study Design Impact on Dose-Scale Pharmacodynamic Bioequivalence: a Case Study Using Orlistat. The AAPS journal 26 (4) (2024)
Maxime Usdin, Valerie Quarmby, James Zanghi, Coen Bernaards, Laura Liao, Joel Laxamana, Benjamin Wu, Steven Swanson, Yuan Song, Patty Siguenza
Immunogenicity of Atezolizumab: Influence of Testing Method and Sampling Frequency on Reported Anti-drug Antibody Incidence Rates. The AAPS journal 26 (4) (2024)
Jie Liu, Yongguo Zhang, Chao Liu, Liang Fang
Effect of Physicochemical Properties on the Basic Drug-Acid-Polymer Interactions and Miscibility in PVA Based Orodispersible Films. The AAPS journal 26 (4) (2024)
Ruwei Yang, Yaqi Lin, Kaifeng Chen, Jie Huang, Shuang Yang, An Yao, Xiaoyan Yang, Deqing Lei, Jing Xiao, Guoping Yang, Qi Pei
Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling. The AAPS journal 26 (4) (2024)
Laura Boffel, Anskje Van Mensel, Janne Pauwels, Elly Den Hond, Jos Bessems, Katleen Van Uytfanghe, Christophe Pol Stove
Self-Sampling by Adolescents at Home: Assessment of the Feasibility to Successfully Collect Blood Microsamples by Inexperienced Individuals. The AAPS journal 26 (4) (2024)
Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Laura Schild Hay, Bethany Ward, Luke Armstrong, Mitra Azadeh, Liching Cao, Rebecca Carmean, Jason DelCarpini, Sanjay L Dholakiya, Amanda Hays, Sarah Hosback, Zheng Hu, Nadia Kulagina, Seema Kumar, Ching Ha Lai, Marit Lichtfuss, Hsing-Yin Liu, Susana Liu, Reza Mozaffari, Luying Pan, Jason Pennucci, Marie-Eve Poupart, Gurleen Saini, Veerle Snoeck, Kristine Storey, Amy Turner, Inna Vainshtein, Daniela Verthelyi, Iwona Wala, Lili Yang, Lin Yang
Neutralizing Antibody Sample Testing and Report Harmonization. The AAPS journal 26 (4) (2024)
Costas Demetzos
Nanosimilars: A Scientific or A Regulatory Debate? The AAPS journal 26 (4) (2024)
Xinying Wang, Yuanyuan Zhang, Kaili Liang, Xue Meng, Chunyan Ma, Xiaohui Li
The Influence of Various Freezing-thawing Methods of Skin on Drug Permeation and Skin Barrier Function. The AAPS journal 26 (4) (2024)
Donna A Volpe
Knockout Transporter Cell Lines to Assess Substrate Potential Towards Efflux Transporters. The AAPS journal 26 (4) (2024)
Deyun Wang, Jiayi Li, Kang Chen
Intact NMR Approach Quickly Reveals Synchronized Microstructural Changes in Oil-in-Water Nanoemulsion Formulations. The AAPS journal 26 (4) (2024)
Hari Prasath Nagaiah, Priya Dharsini Periyakaruppan Murugesan, Chaughule Vrushali Ravindra Rupali, Shunmugiah Thevar Karutha Pandian
Pioneering Topical Ointment Intervention for Unprecedented Antimicrobial and Diabetic Wound Management with Phenylpropanoids and Nano-Silver. The AAPS journal 26 (4) (2024)
Rafael Dal-Ré, Ignacio Mahillo Fernández
Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis. The AAPS journal 26 (4) (2024)
Rudiger Kaspera, Yoshihisa Shitara
Doses Evaluated in Clinical Pharmacology Studies Investigating the Effect of Intrinsic and Extrinsic Factors on PK and Safety: Case Examples from Approved Drug Development Programs. The AAPS journal 26 (4) (2024)
Rudiger Kaspera, Yoshihisa Shitara
Doses Evaluated in Clinical Pharmacology Studies Investigating the Effect of Intrinsic and Extrinsic Factors on PK and Safety: Case Examples from Approved Drug Development Programs. The AAPS journal 26 (4) (2024)
Rafael Dal-Ré, Ignacio Mahillo Fernández
Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis. The AAPS journal 26 (4) (2024)
Hari Prasath Nagaiah, Priya Dharsini Periyakaruppan Murugesan, Chaughule Vrushali Ravindra Rupali, Shunmugiah Thevar Karutha Pandian
Pioneering Topical Ointment Intervention for Unprecedented Antimicrobial and Diabetic Wound Management with Phenylpropanoids and Nano-Silver. The AAPS journal 26 (4) (2024)
Sivacharan Kollipara, Mahendra Chougule, Rajkumar Boddu, Ashima Bhatia, Tausif Ahmed
Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges? The AAPS journal 26 (4) (2024)

volume 26, number 5, 2024

Arvind Kinhikar, Mohamed Hassanein, Jake Harman, Catherine Soderstrom, Kimberly Honrine, Amy Lavelle, Marie-Anne Valentin, Joel Mathews
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices. The AAPS journal 26 (5) (2024)
Elena Maria Tosca, D Ronchi, M Rocchetti, Paolo Magni
Predicting Tumor Volume Doubling Time and Progression-Free Survival in Untreated Patients from Patient-Derived-Xenograft (PDX) Models: A Translational Model-Based Approach. The AAPS journal 26 (5) (2024)
Tianshu Gu, Guiying Wang, Edwin J C van den Oord, Emanuel Goldman, Chengyuan Yang, Ning Xie, Lan Yao, Cong-Yi Wang, Monica Jablonski, Kunal Ray, Fengxia Liu, Wensen Pan, Gonzalo Flores, Lotfi Aleya, Xia Meng, Yan Jiao, Minghui Li, Yongjun Wang, Weikuan Gu
A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions. The AAPS journal 26 (5) (2024)
Erica L Friedman, Leah W Falade, Michael G Bartlett
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013-2022. The AAPS journal 26 (5) (2024)
Guiqin Liu, Qian Wang, Lu Tian, Mengyue Wang, Delong Duo, Yabin Duan, Yue Lin, Junjun Han, Qiangqiang Jia, Junbo Zhu, Xiangyang Li
Blood-Brain Barrier Permeability is Affected by Changes in Tight Junction Protein Expression at High-Altitude Hypoxic Conditions-this may have Implications for Brain Drug Transport. The AAPS journal 26 (5) (2024)
Dulla Naveen Kumar, Aiswarya Chaudhuri, Udita Shiromani, Dinesh Kumar, Ashish Kumar Agarwal
An Investigation of In Vitro Anti-Cancer Efficacy of Dihydroartemisinin-Loaded Bovine Milk Exosomes Against Triple-Negative Breast Cancer. The AAPS journal 26 (5) (2024)
Arvind Kinhikar, Mohamed Hassanein, Jake Harman, Catherine Soderstrom, Kimberly Honrine, Amy Lavelle, Marie-Anne Valentin, Joel Mathews
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices. The AAPS journal 26 (5) (2024)
Faye Vazvaei-Smith, Enaksha Wickremsinhe, Eric Woolf, Chongwoo Yu
ICH M10 Bioanalytical Method Validation Guideline-1 year Later. The AAPS journal 26 (5) (2024)
Wanjie Sun, Mohamed Alosh, Donald J Schuirmann, Stella Grosser
Letter to the Editor on "Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies". The AAPS journal 26 (5) (2024)
Mark Klitgaard Nøhr, Shaik Rizwan Waheed, Rasmus Juul Kildemoes, Vibeke Hatorp, Tine Aggerholm Bækdal, Charlotte Lindorff Adrian, Lars Peter Korsholm, Eva Lisby Arp-Hansen, Helle Holst, Scott W Roberts
A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection. The AAPS journal 26 (5) (2024)
David Lee, Andrew M Shen, Olga B Garbuzenko, Tamara Minko
Liposomal Formulations of Anti-Alzheimer Drugs and siRNA for Nose-to-Brain Delivery: Design, Safety and Efficacy In Vitro. The AAPS journal 26 (5) (2024)
Qiang Qu, Susana Liu, Zhiping You, Gregory S Steeno, Lisa A Dyleski, Xue Mu, Ying Wang, Daniel Baltrukonis
A Data Driven Strategy and Case Study for Implementation of Singlicate Analysis in Ligand Binding Assays Used for PK Quantitation. The AAPS journal 26 (5) (2024)
Carley Karsten, Karin Grannas, Oskar Bergman, Robert Movérare, Matthew Roforth, Maria Alice V Willrich, Melissa R Snyder, Yifei K Yang
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation. The AAPS journal 26 (5) (2024)
Michel Y Louge, Jasdeep Mandur, Plamen Grigorov, William D Blincoe, David Lamberto, Colton Bower, Robert F Meyer
Non-Invasive, Continuous, Quantitative Detection of Solvent Content in Vacuum Tray Drying. The AAPS journal 26 (5) (2024)
Kanwal Khalid, Hui Xuan Lim, Jung Shan Hwang, Chit Laa Poh
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2. The AAPS journal 26 (5) (2024)
Arvind Kinhikar, Mohamed Hassanein, Jake Harman, Catherine Soderstrom, Kimberly Honrine, Amy Lavelle, Marie-Anne Valentin, Joel Mathews
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices. The AAPS journal 26 (5) (2024)
Ruihuan Ding, Yanping Li, Wei Zheng, Yiying Sun, Zhenyu Zhao, Houqian Zhang, Ranran Yuan, Aiping Wang, Kaoxiang Sun, Hongbo Wang, Yanan Shi
Design of Auto-Adaptive Drug Delivery System for Effective Delivery of Peptide Drugs to Overcoming Mucus and Epithelial Barriers. The AAPS journal 26 (5) (2024)
Mitra Azadeh, Jeremy Good, Michele Gunsior, Nadia Kulagina, Yanmei Lu, Jim McNally, Heather Myler, Yan G Ni, Ryan Pelto, Karen J Quadrini, Catherine E Vrentas, Lin Yang
Best Practices for Development and Validation of Enzymatic Activity Assays to Support Drug Development for Inborn Errors of Metabolism and Biomarker Assessment. The AAPS journal 26 (5) (2024)
Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Laura Schild Hay, Bethany Ward, Luke Armstrong, Mitra Azadeh, Liching Cao, Rebecca Carmean, Jason DelCarpini, Sanjay L Dholakiya, Amanda Hays, Sarah Hosback, Zheng Hu, Nadia Kulagina, Seema Kumar, Ching Ha Lai, Marit Lichtfuss, Hsing-Yin Liu, Susana Liu, Reza Mozaffari, Luying Pan, Jason Pennucci, Marie-Eve Poupart, Gurleen Saini, Veerle Snoeck, Kristine Storey, Amy Turner, Inna Vainshtein, Daniela Verthelyi, Iwona Wala, Lili Yang, Lin Yang
Correction to: Neutralizing Antibody Sample Testing and Report Harmonization. The AAPS journal 26 (5) (2024)
Stacey Marden, John M Campbell, Neal Adams, Ronan Coelho, Chris Foti, Juçara Ribeiro Franca, Steven Hostyn, Zongyun Huang, Mariah Ultramari, Todd Zelesky, Steven W Baertschi
Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications. The AAPS journal 26 (5) (2024)
Andrew Shahidehpour, Mudassir Rashid, Mohammad Reza Askari, Mohammad Ahmadasas, Mahmoud Abdel-Latif, Cynthia Fritschi, Lauretta Quinn, Sirimon Reutrakul, Ulf G Bronas, Ali Cinar
Modeling Metformin and Dapagliflozin Pharmacokinetics in Chronic Kidney Disease. The AAPS journal 26 (5) (2024)

volume 26, number 6, 2024

Richard Burdick, Jeff Hofer, Andrew Karl, Heath Rushing
Planning Split-Apheresis Designs for Demonstrating Comparability of Cellular and Gene Therapy Products. The AAPS journal 26 (6) (2024)
Yanshan Dai, Xinqun Wu, Xiaowei Sun, Daniel Cohen, Divakar Rajeswaran, Scott Robotham, Shannon Chilewski, Kun Yang, Graham Yearwood, Alexander Kozhich, Vibha Jawa
Determining the Degree of Sulfo-tag Conjugation to AAV5 Vectors by LC-HRMS and Evaluating the Effects on Antibody Binding Affinity and Bridging Assay Sensitivity. The AAPS journal 26 (6) (2024)
Ajith Kumar Ethirajulu, Vineesh Sriramoju, Amruta Gajanan Bhat, Murali Ramanathan
Evaluating AlphaFold for Clinical Pharmacology and Pharmacogenetics: A Case-Study of Huntingtin Variants Linked to Huntington's Disease. The AAPS journal 26 (6) (2024)