-
Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes AAPS J. (IF 4.5) Pub Date : 2024-03-14
Abstract ICH Q12 asserts that science- and risk-based approaches are applicable to stability studies supporting Chemistry, Manufacturing and Controls (CMC) post-approval changes (PAC) to enable more timely implementation; however, no guidance or specific examples are provided to demonstrate how prior knowledge of the product can inform the risk assessment for the proposed change(s). Ten diverse case
-
Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution AAPS J. (IF 4.5) Pub Date : 2024-03-13
Abstract The clinical use of therapeutic monoclonal antibodies (mAbs) for the treatment of cancer, inflammation, and other indications has been successfully established. A critical aspect of drug-antibody pharmacokinetics is immunogenicity, which triggers an immune response via an anti-drug antibody (ADA) and forms drug/ADA immune complexes (ICs). As a consequence, there may be a reduced efficacy upon
-
Quality by Design Framework Applied to GMMA Purification AAPS J. (IF 4.5) Pub Date : 2024-03-08
Abstract In recent years, Generalized Modules for Membrane Antigens (GMMA) have received increased attention as an innovative vaccine platform against bacterial pathogens, particularly attractive for low- and middle-income countries because of manufacturing simplicity. The assessment of critical quality attributes (CQAs), product-process interactions, identification of appropriate in process analytical
-
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework AAPS J. (IF 4.5) Pub Date : 2024-03-07 Jason H. Williams, Kai H. Liao, Donghua Yin, Xu Meng
-
A Short Update on the Use of Monoclonal Antibodies in COVID-19 AAPS J. (IF 4.5) Pub Date : 2024-03-05
Abstract Monoclonal antibodies in the prophylaxis and treatment of COVID-19 have been crucial in reducing severe infections when vaccines were unavailable. However, as the virus and its variants have changed over time, the effectiveness of monoclonal antibodies has been questioned. This technical note highlights the need to assess the antiviral activity of these antibodies against new variants and
-
Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data AAPS J. (IF 4.5) Pub Date : 2024-03-05
Abstract Despite the promising potential of direct central nervous system (CNS) antibody administration to enhance brain exposure, there remains a significant gap in understanding the disposition of antibodies following different intra-CNS injection routes. To bridge this knowledge gap, this study quantitatively investigated the brain pharmacokinetics (PK) of antibodies following intra-CNS administration
-
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA AAPS J. (IF 4.5) Pub Date : 2024-02-27 Lanyan Fang, Yuqing Gong, Andrew C. Hooker, Viera Lukacova, Amin Rostami-Hodjegan, Mark Sale, Stella Grosser, Rebeka Jereb, Rada Savic, Carl Peck, Liang Zhao
-
Characterization of CYP3A5 Selective Inhibitors for Reaction Phenotyping of Drug Candidates AAPS J. (IF 4.5) Pub Date : 2024-02-16 Jie Chen, Lloyd Wei Tat Tang, Samantha Jordan, Makayla Harrison, Gabrielle M. Gualtieri, Ethan DaSilva, Danial Morris, Gary Bora, Ye Che, Li Di
-
Taurine, a Naturally Occurring Amino Acid, as a Physical Stability Enhancer of Different Monoclonal Antibodies AAPS J. (IF 4.5) Pub Date : 2024-02-14 Shravan Sreenivasan, Anurag S. Rathore
-
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development AAPS J. (IF 4.5) Pub Date : 2024-02-05 Amanda Hays, Mark Wissel, Kelly Colletti, Russell Soon, Mitra Azadeh, Justin Smith, Rajitha Doddareddy, Melanie Chalfant, Wendy Adamowicz, Swarna Suba Ramaswamy, Sanjay L. Dholakiya, Sebastian Guelman, Bryan Gullick, Jennifer Durham, Keith Rennier, Pruthvi Nagilla, Anamica Muruganandham, Manisha Diaz, Cassandra Tierney, Kaarthik John, Jenny Valentine, Timothy Lockman, Hsing-Yin Liu, Benjamin Moritz
-
Agreement Between a Colorimetric Assay and Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry for Quantifying Paracetamol Plasma Concentrations AAPS J. (IF 4.5) Pub Date : 2024-02-01
Abstract Special populations, like geriatric patients, experience altered paracetamol pharmacokinetics (PK), complicating pain management. More PK research is essential to optimize paracetamol (acetaminophen) dosing. Yet, the reference method ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) is not readily available. Therefore, we aimed to evaluate the agreement between
-
An Explanation of Why Dose-Corrected Area Under the Curve for Alternate Administration Routes Can Be Greater than for Intravenous Dosing AAPS J. (IF 4.5) Pub Date : 2024-01-30 Hirokazu Wakuda, Yue Xiang, Jasleen K. Sodhi, Naoto Uemura, Leslie Z. Benet
-
Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models AAPS J. (IF 4.5) Pub Date : 2024-01-25 Leticia Arrington, Mats O. Karlsson
-
Successful Development of Nonclinical Anti-Drug Antibody Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies AAPS J. (IF 4.5) Pub Date : 2024-01-24 Audrey Arjomandi, Ketevan Siradze, Melissa Cheu, Teresa Davancaze, Rajbharan Yadav, Gautham K. Rao, Lisa Wong, Saloumeh K. Fischer
-
Connexin-Containing Vesicles for Drug Delivery AAPS J. (IF 4.5) Pub Date : 2024-01-24
Abstract Connexin is a transmembrane protein present on the cell membrane of most cell types. Connexins assemble into a hexameric hemichannel known as connexon that pairs with another hemichannel present on a neighboring cell to form gap junction that acts as a channel or pore for the transport of ions and small molecules between the cytoplasm of the two cells. Extracellular vesicles released from
-
Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development AAPS J. (IF 4.5) Pub Date : 2024-01-24 Yuqing Gong, Francis-Xavier Barretto, Yi Tsong, Youssef Mousa, Ke Ren, Darby Kozak, Meiyu Shen, Meng Hu, Liang Zhao
-
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay AAPS J. (IF 4.5) Pub Date : 2024-01-24
Abstract Non-neutralizing anti-idiotype antibodies against a therapeutic monoclonal antibody (mAb) play a crucial role in the creation of total pharmacokinetic (PK) assays and total target engagement (TE) assays during both pre-clinical and clinical development. The development of these anti-idiotype antibodies is challenging. In this study, we utilized a hybridoma platform to produce a variety of
-
Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model AAPS J. (IF 4.5) Pub Date : 2024-01-24
Abstract Ritlecitinib, an orally available Janus kinase 3 and tyrosine kinase inhibitor being developed for the treatment of alopecia areata (AA), is highly soluble across the physiological pH range at the therapeutic dose. As such, it is expected to dissolve rapidly in any in vitro dissolution conditions. However, in vitro dissolution data showed slower dissolution for 100-mg capsules, used for the
-
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products AAPS J. (IF 4.5) Pub Date : 2024-01-24 Fang Wu, Youssef Mousa, Rebeka Jereb, Hannah Batchelor, Sumon Chakraborty, Tycho Heimbach, Ethan Stier, Filippos Kesisoglou, Sivacharan Kollipara, Lei Zhang, Liang Zhao
-
Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report AAPS J. (IF 4.5) Pub Date : 2024-01-10 Eleftheria Tsakalozou, Lanyan Fang, Youwei Bi, Michiel van den Heuvel, Tausif Ahmed, Yu Chung Tsang, Robert Lionberger, Amin Rostami-Hodjegan, Liang Zhao
-
Building a Predictive PBPK Model for Human OATP Substrates: a Strategic Framework for Early Evaluation of Clinical Pharmacokinetic Variations Using Pitavastatin as an Example AAPS J. (IF 4.5) Pub Date : 2024-01-05 Xiaomin Liang, Megan L. Koleske, Jesse Yang, Yurong Lai
-
Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products AAPS J. (IF 4.5) Pub Date : 2024-01-04 Ross L. Walenga, Andrew H. Babiskin, Sid Bhoopathy, James F. Clarke, Jan De Backer, Murray Ducharme, Marc Kelly, Maxime Le Merdy, Miyoung Yoon, Partha Roy
-
A Bispecific Modeling Framework Enables the Prediction of Efficacy, Toxicity, and Optimal Molecular Design of Bispecific Antibodies Targeting MerTK AAPS J. (IF 4.5) Pub Date : 2024-01-02 Ran Li, Edward Dere, Mandy Kwong, Mingjian Fei, Rutwij Dave, Shabkhaiz Masih, Joy Wang, Erin McNamara, Haochu Huang, Wei-Ching Liang, Leah Schutt, Amrita V. Kamath, Meric A. Ovacik
-
Design, Synthesis, and Biochemical Analysis of a Molecule Designed to Enhance Endosomal Escape AAPS J. (IF 4.5) Pub Date : 2023-12-22 Satish G. Jadhav, Ryan L. Setten, Carlos Medina, Xian-Shu Cui, Steven F. Dowdy
-
Novel Selective Quantification of Zinpentraxin Alfa Biotherapeutic in the Presence of Endogenous Isomer in Plasma Samples of Idiopathic Pulmonary Fibrosis Patients Using Immunoaffinity LC–MS AAPS J. (IF 4.5) Pub Date : 2023-12-19 Maoyin Li, Audrey Arjomandi, Xiaowei Sun, Erhu Lu, Tulika Tyagi, WeiYu Lin, Saloumeh K. Fischer, Surinder Kaur, Keyang Xu
-
Notes on the Use of Kirchhoff’s Laws in Pharmacokinetics AAPS J. (IF 4.5) Pub Date : 2023-12-19 Ronald A. Siegel
-
Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19 AAPS J. (IF 4.5) Pub Date : 2023-12-19 Michelle Stafford, Rachel Linck Dunn, Nirzari Gupta, Raghavi Kakarla, Douglas Kirkpatrick, Daniel Magparangalan, Diem Ngo, Connie Gryniewicz-Ruzicka, Anjanette Smith, Matthew Stark, Wei Ye, Huzeyfe Yilmaz, Jeffrey Woodruff, Mary Manibusan, Neil Stiber, Alex Viehmann
-
Pharmacodynamics of Cyclin D1 Degradation in Ovarian Cancer Xenografts with Repeated Oral SHetA2 Dosing AAPS J. (IF 4.5) Pub Date : 2023-12-12 Ankur Sharma, Xin Liu, Vishal Chandra, Rajani Rai, Doris M. Benbrook, Sukyung Woo
-
A Population Model of Time-Dependent Changes in Serum Creatinine in (Near)term Neonates with Hypoxic-Ischemic Encephalopathy During and After Therapeutic Hypothermia AAPS J. (IF 4.5) Pub Date : 2023-12-05 Wojciech Krzyzanski, Pia Wintermark, Pieter Annaert, Floris Groenendaal, Suzan Şahin, Mehmet Yekta Öncel, Didem Armangil, Esin Koc, Malcolm R. Battin, Alistair J. Gunn, Adam Frymoyer, Valerie Y.-L. Chock, Elif Keles, Djalila Mekahli, John van den Anker, Anne Smits, Karel Allegaert
-
-
Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development AAPS J. (IF 4.5) Pub Date : 2023-11-16 Hester Kramer, Ceyhun Bicer, Christian Otoul, Chiara Rospo, Merran Macpherson, Mark Watling, Massimo Bani, David Sciberras, Hugues Chanteux
-
The AAPS Journal Theme Issue: "Perspectives on Clinical Drug Development of Long-Acting Injectables". AAPS J. (IF 4.5) Pub Date : 2023-11-14 Huybrecht T'jollyn,Oliver Ackaert
-
Drug Dissolution in Oral Drug Absorption: Workshop Report AAPS J. (IF 4.5) Pub Date : 2023-11-07 Kimberly Raines, Payal Agarwal, Patrick Augustijns, Alaadin Alayoubi, Lucas Attia, Annette Bauer-Brandl, Martin Brandl, Parnali Chatterjee, Hansong Chen, Yuly Chiang Yu, Carrie Coutant, Ana Luisa Coutinho, David Curran, Jennifer Dressman, Bryan Ericksen, Leah Falade, Yi Gao, Zongming Gao, Debasis Ghosh, Tapash Ghosh, Anitha Govada, Elizabeth Gray, Ruiqiong Guo, Dana Hammell, Andre Hermans, Rohit Jaini
The in-person workshop “Drug Dissolution in Oral Drug Absorption” was held on May 23–24, 2023, in Baltimore, MD, USA. The workshop was organized into lectures and breakout sessions. Three common topics that were re-visited by various lecturers were amorphous solid dispersions (ASDs), dissolution/permeation interplay, and in vitro methods to predict in vivo biopharmaceutics performance and risk. Topics
-
Tuning the Emulsion Properties Influences the Size of Poly(Caprolactone) Particles for Drug Delivery Applications AAPS J. (IF 4.5) Pub Date : 2023-10-27 Ashbey N. Manning, Claire E. Rowlands, Hope Saindon, Brittany E. Givens
-
A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications AAPS J. (IF 4.5) Pub Date : 2023-10-27 Shiny Amala Priya Rajan, Jason Sherfey, Shivam Ohri, Lauren Nichols, J. Tyler Smith, Paarth Parekh, Eugene P. Kadar, Frances Clark, Billy T. George, Lauren Gregory, David Tess, James R. Gosset, Jennifer Liras, Emily Geishecker, R. Scott Obach, Murat Cirit
-
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors AAPS J. (IF 4.5) Pub Date : 2023-10-27 Tao Zhang, Peng Zou
-
Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development AAPS J. (IF 4.5) Pub Date : 2023-10-17 Maxime Siemons, Bram Schroyen, Nicolas Darville, Navin Goyal
-
Quantitative Translation of Substrate Intrinsic Clearance from Recombinant CYP1A1 to Humans AAPS J. (IF 4.5) Pub Date : 2023-10-05 Li Di
-
RNA Nanomedicine: Delivery Strategies and Applications AAPS J. (IF 4.5) Pub Date : 2023-10-02 Junho Byun, Yina Wu, Jinwon Park, Jung Suk Kim, Qiaoyun Li, Jaehyun Choi, Namjo Shin, Meng Lan, Yu Cai, Jaiwoo Lee, Yu-Kyoung Oh
-
Single Particle Chemical Characterisation of Nanoformulations for Cargo Delivery AAPS J. (IF 4.5) Pub Date : 2023-10-02 Catherine Saunders, Camille A. de Villiers, Molly M. Stevens
-
An Antibody-Dependent Cellular Cytotoxicity Assay for Detecting Ocrelizumab Neutralizing Antibody AAPS J. (IF 4.5) Pub Date : 2023-10-02 Van Nguyen, Anthony Cheung, Robert Hendricks, Kun Peng, Shan Chung
-
Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary AAPS J. (IF 4.5) Pub Date : 2023-10-02 Eleftheria Tsakalozou, Mohamed-Eslam F. Mohamed, Sebastian Polak, Tycho Heimbach
-
Optimization of Peripheral Blood Mononuclear Cell Processing for Improved Clinical ELISpot Assay Performance AAPS J. (IF 4.5) Pub Date : 2023-09-28 Xinyuan Li, Shan He, Jaya Thomas, Bonnie Wu, Tong-Yuan Yang, Michael Swanson
-
Addressing Domain Specificity in the Development of a Cell-Based Binding Assay for the Detection of Neutralizing Antibodies Against a CD47xPD-L1 Bispecific Antibody AAPS J. (IF 4.5) Pub Date : 2023-09-22 Michael Luong, Ying Wang, Brianna B. Donnelly, Christopher Lepsy
-
Fabrication and Characterization of Antibody-Loaded Cationic Porous PLGA Microparticles for Sustained Antibody Release AAPS J. (IF 4.5) Pub Date : 2023-09-22 Ayaka Hanaki, Koki Ogawa, Tatsuaki Tagami, Tetsuya Ozeki
-
A Case Study for Critical Reagent Qualification for Ligand Binding Assays Using Equivalence Test Methodology AAPS J. (IF 4.5) Pub Date : 2023-09-15 Nancy A. Niemuth, Cheryl A. Triplett, Michael S. Anderson, Karen A. Sankovich, Thomas L. Rudge
-
Phase-appropriate Application of Process Analytical Technology for Early Pharmaceutical Development of Oral Solid Dosage Forms—the Case Study of Uniformity Screening of Dosage Units and Blends AAPS J. (IF 4.5) Pub Date : 2023-09-15 Sayyeda Zeenat Razvi, Shengli Ma, Qiqing Zhong, Ariel Muliadi, Zhenqi (Pete) Shi
-
Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics AAPS J. (IF 4.5) Pub Date : 2023-09-11 Kirk Haltaufderhyde, Brian J. Roberts, Sundos Khan, Frances Terry, Christine M. Boyle, Mitchell McAllister, William Martin, Amy Rosenberg, Anne S. De Groot
-
Ensemble Machine Learning Approaches Based on Molecular Descriptors and Graph Convolutional Networks for Predicting the Efflux Activities of MDR1 and BCRP Transporters AAPS J. (IF 4.5) Pub Date : 2023-09-12 Asahi Adachi, Tomoki Yamashita, Shigehiko Kanaya, Yohei Kosugi
-
Human Brain Penetration Prediction Using Scaling Approach from Animal Machine Learning Models AAPS J. (IF 4.5) Pub Date : 2023-09-05 Siyu Liu, Yohei Kosugi
-
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study AAPS J. (IF 4.5) Pub Date : 2023-09-02 Fred McCush, Ellen Wang, Carla Yunis, Pamela Schwartz, Daniel Baltrukonis
-
Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab AAPS J. (IF 4.5) Pub Date : 2023-08-23 Jean Donley, Darshana Jani, Tong Zhu, Yuhong Xiang, Boris Gorovits, Steven Arkin
-
Nature vs. Manmade: Comparing Exosomes and Liposomes for Traumatic Brain Injury AAPS J. (IF 4.5) Pub Date : 2023-08-23 Kate Hennigan, Erin Lavik
-
Overcoming Soluble Target Interference in Measurement of Total Bispecific Therapeutic Antibody Concentrations AAPS J. (IF 4.5) Pub Date : 2023-08-18 Jeongsup Shim, Jessica Chen, Montserrat Carrasco-Triguero, Saloumeh K. Fischer
-
Gastrointestinal Delivery of an mRNA Vaccine Using Immunostimulatory Polymeric Nanoparticles AAPS J. (IF 4.5) Pub Date : 2023-08-17 Hyunjoon Kim, Ameya R. Kirtane, Na Yoon Kim, Netra Unni Rajesh, Chaoyang Tang, Keiko Ishida, Alison M. Hayward, Robert Langer, Giovanni Traverso
-
Targeting Macrophages for Tumor Therapy AAPS J. (IF 4.5) Pub Date : 2023-08-17 Yixin Wang, Allie Barrett, Quanyin Hu
-
Real-Time Tracking of In Situ-Forming Alginate Hydrogel by Contrast-Enhanced Computed Tomography AAPS J. (IF 4.5) Pub Date : 2023-08-08 Natalie Guirguis, Yanis Zellagui, Simon Matoori
-
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper AAPS J. (IF 4.5) Pub Date : 2023-07-31 Uma Kavita, Kefeng Sun, Manuela Braun, Wibke Lembke, Hardik Mody, John Kamerud, Tong-Yuan Yang, Inka V. Braun, Xiaodong Fang, Wei Gao, Swati Gupta, Magdalena Hofer, Michael Z. Liao, LiNa Loo, Fraser McBlane, Karelle Menochet, Kay-Gunnar Stubenrauch, Vijay V. Upreti, Adam Vigil, Christopher M. Wiethoff, Cindy Q. Xia, Xu Zhu, Vibha Jawa, Nagendra Chemuturi
-
Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions AAPS J. (IF 4.5) Pub Date : 2023-07-27 Tausif Ahmed, Sivacharan Kollipara, Rajkumar Boddu, Adithya Karthik Bhattiprolu
-
Stochastic Differential Equation-based Mixed Effects Model of the Fluid Volume in the Fasted Stomach in Healthy Adult Human AAPS J. (IF 4.5) Pub Date : 2023-07-27 Kai Wang, Luca Marciani, Gordon L. Amidon, David E. Smith, Duxin Sun