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Robust and Adaptive Two-stage Designs in Nonlinear Mixed Effect Models Lucie FayetteRomain LerouxJérémy Seurat Research Article 13 July 2023 Article: 71
An AI Approach to Generating MIDD Assets Across the Drug Development Continuum Jeffrey S BarrettRahul K GoyalJyotika Varshney Commentary Open access 10 July 2023 Article: 70
Neutralizing Antibody Validation Testing and Reporting Harmonization Heather MylerJoão Pedras-VasconcelosStephanie Pasas-Farmer White Paper Open access 08 July 2023 Article: 69
Enhanced Pharmacokinetic Bioanalysis of Antibody–drug Conjugates using Hybrid Immunoaffinity Capture and Microflow LC-MS/MS Moo-jin SuhJoshua B. PowersYuling Wu Research Article 29 June 2023 Article: 68
Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study Gopal PawarFang WuHannah K. Batchelor Research Article Open access 29 June 2023 Article: 67
A PKPD Case Study: Achieving Clinically Relevant Exposures of AZD5991 in Oncology Mouse Models Michael J. WhiteLetitia CheathamChristina Vasalou Research Article 28 June 2023 Article: 66
Lipid Nanoparticle-Enabled Intracellular Delivery of Prime Editors Marco Herrera-BarreraMilan GautamGaurav Sahay Research Article 28 June 2023 Article: 65
Mini-PBPK-Based Population Model and Covariate Analysis to Assess the Complex Pharmacokinetics and Pharmacodynamics of RO7449135, an Anti-KLK5/KLK7 Bispecific Antibody in Cynomolgus Monkeys Hao CaiXun TaoEric Stefanich Research Article 23 June 2023 Article: 64
Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies Prajwala KarnatiAditya MurthyTausif Ahmed Review Article 23 June 2023 Article: 63
Evaluation of the Potential for Drug-Drug Interactions with Inhaled Itraconazole Using Physiologically Based Pharmacokinetic Modelling, Based on Phase 1 Clinical Data Mackenzie Bergagnini-KolevKatie KaneAidan K. Curran Research Article Open access 21 June 2023 Article: 62
Multifaceted Approach for Quantification and Enzymatic Activity of Iduronate-2-Sulfatase to Support Developing Gene Therapy for Hunter Syndrome Peter M. FranchiNadia KulaginaHiroshi Sugimoto Research Article 20 June 2023 Article: 61
Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis Filippos KesisoglouSumit BasuArian Emami Riedmaier Research Article 15 June 2023 Article: 60
Correction: 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 Correction 13 June 2023 Article: 59
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Anti-melanoma Effects of Resiquimod (RSQ) In Vitro and in Combination with Immune Checkpoint Blockade In Vivo Supreeda TambunlertchaiSean M. GearyAliasger K. Salem Research Article 02 June 2023 Article: 57
Population-Based Pharmacodynamic Modeling of Omalizumab in Pediatric Patients with Moderate to Severe Persistent Inadequately Controlled Allergic Asthma Rui ZhuXiaoning WangRyan Owen Research Article Open access 02 June 2023 Article: 56
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development Jochem GokemeijerYi WenSofie Pattijn Research Article 02 June 2023 Article: 55
Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins Elimika Pfuma FletcherMartina SahreYow-Ming C. Wang Commentary 26 May 2023 Article: 54
Predicting Human Bioavailability of Subcutaneously Administered Monoclonal Antibodies Using Non-human Primate Linear Clearance and Antibody Isoelectric Point Peng Zou Research Article 25 May 2023 Article: 53
Micellar Encapsulation of Propofol Reduces its Adsorption on Extracorporeal Membrane Oxygenator (ECMO) Circuit Nitish KhuranaTill SünnerKevin M. Watt Research Article 25 May 2023 Article: 52