Amgen v. Sanofi: Critical Impact on the Value of Innovative Science in Antibody Discovery Joseph P. Balthasar Commentary 12 May 2023 Article: 51
A Precise qNMR Method for the Rapid Quantification of Lot-to-Lot Variations in Multiple Quality Attributes of Pentosan Polysulfate Sodium Kai WangWeixiang DaiKang Chen Protocols in Pharmaceutical Sciences 06 May 2023 Article: 50
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop René HolmRobert W. LeeSimone Alidori Review Article 28 April 2023 Article: 49
Physiologically Based Pharmacokinetic Modeling to Characterize the Effect of Molecular Charge on Whole-Body Disposition of Monoclonal Antibodies Shufang LiuDhaval K. Shah Research Article 28 April 2023 Article: 48
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy Boris GorovitsMitra AzadehBonnie Wu Review Article 26 April 2023 Article: 47
The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method Zongming GaoAnjanette Smith Research Article 26 April 2023 Article: 46
Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets Yasuhiro TsumeLee AshworthLaurin Zöller Research Article Open access 21 April 2023 Article: 45
Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization Andreas M. AbendThomas HoffelderTycho Heimbach Commentary 21 April 2023 Article: 44
The AAPS Journal Theme Issue: Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work Johanna R. MoraSusan M. Richards Editorial 20 April 2023 Article: 43
Quantitative Analysis of Gastrointestinal Water Dynamics by Means of a Physiologically Based Fluid Kinetic Model Satoru SuzukiKatsuhisa InoueYoshiyuki Shirasaka Research Article 20 April 2023 Article: 42
A Pharmacometrics Model to Characterize a New Type of Target-Mediated Drug Disposition (TMDD) – Nonlinear Pharmacokinetics of Small-Molecule PF-07059013 Mediated By Its High-capacity Pharmacological Target Hemoglobin With Positive Cooperative Binding Min XuGuohua An Research Article 13 April 2023 Article: 41
In Vitro-In Vivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes David TessGeorge C. ChangLi Di Research Article 13 April 2023 Article: 40
Plasma Stability and Plasma Metabolite Concentration–Time Profiles of Oligo(Lactic Acid)8-Paclitaxel Prodrug Loaded Polymeric Micelles Lauren ReppSarah L. SkoczenGlen S. Kwon Research Article 11 April 2023 Article: 39
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry Leslie Z. BenetJasleen K. Sodhi Research Article Open access 10 April 2023 Article: 38
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal John GarlitsSean McAfeeMichael A. Partridge Research Article Open access 04 April 2023 Article: 37
Dependence of Bioavailability on Mean Absorption Time: What Does It Tell Us? Michael WeissWerner Siegmund Research Article 04 April 2023 Article: 36
Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum Yanshan DaiHuijin DongVibha Jawa Research Article 03 April 2023 Article: 35
Correction: Preclinical In Vivo Data Integrated in a Modeling Network Informs a Refined Clinical Strategy for a CD3 T‑Cell Bispecific in Combination with Anti‑PD‑L1 Javier SánchezValeria NicoliniNicolas Frances Correction 01 April 2023 Article: 34
Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation Peng ZouJayabharathi VaidyanathanShirley K. Seo Research Article 29 March 2023 Article: 33
Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics Vivek PurohitYeamin HuhTimothy Nicholas Research Article Open access 28 March 2023 Article: 32
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point Peng Zou Research Article 23 March 2023 Article: 31
Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling Dwaipayan MukherjeeMong-Jen ChenPatrick Marroum Research Article 22 March 2023 Article: 30
Development of Drug Release Model for Suspensions in ESCAR (Emulator of SubCutaneous Absorption and Release) Hao LouMichael J. Hageman Research Article 22 March 2023 Article: 29