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The AAPS Journal|January 22, 2025
Gastrointestinal Bile Salt Concentrations in Healthy Adults Under Fasted and Fed Conditions: A Systematic Review and Meta-Analysis for Mechanistic Physiologically-Based Pharmacokinetic (PBPK) ModellingLaura G Al-Amiry Santos, Helen Musther, Neeru Bala, et al.
The AAPS Journal|January 17, 2025
Comparison of RT-qPCR With Branched DNA to Quantify a Lipid Nanoparticle-Encapsulated mRNA Therapeutic in Serum and Liver Tissue Samples From Nonclinical PK StudiesJessica Ortiz, Laura Brunner, Lei Ci, et al.
The AAPS Journal|November 14, 2024
Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/BypassDaniel Porat, Oleg Dukhno, Sandra Cvijić, et al.
The AAPS Journal|November 19, 2024
Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of AdalimumabDawon Jang, Jaeil Kim, Youngwon Jo, et al.
The AAPS Journal|November 12, 2024
Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023Ryosuke Kuribayashi, Kanoko Goto, Takumi Ogawa
The AAPS Journal|March 13, 2025
Uniform Spray Dried Loxapine Microparticles Potentially for Nasal Delivery: Exploring Discriminatory In Vitro Release Evaluation MethodsMengyuan Li, Ziwei Nie, Shen Yan, et al.
The AAPS Journal|October 8, 2024
Assessing Immunogenicity in Drug Reviews and Prescribing Information in JapanMitsuru Ishibai, Megumi Kai, Hirokazu Wakuda, et al.
The AAPS Journal|September 12, 2024
ICH M10 Bioanalytical Method Validation Guideline-1 year LaterFaye Vazvaei-Smith, Enaksha Wickremsinhe, Eric Woolf, et al.
The AAPS Journal|September 4, 2024
A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous InjectionMark Klitgaard Nøhr, Shaik Rizwan Waheed, Rasmus Juul Kildemoes, et al.
The AAPS Journal|August 8, 2024
Predicting Tumor Volume Doubling Time and Progression-Free Survival in Untreated Patients from Patient-Derived-Xenograft (PDX) Models: A Translational Model-Based ApproachE M Tosca, D Ronchi, M Rocchetti, et al.
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