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                             23 results found
no title author magazine year volume issue page(s) type
1 Amgen v. Sanofi: Critical Impact on the Value of Innovative Science in Antibody Discovery Balthasar, Joseph P.

25 3 article
2 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 Xu, Min

25 3 article
3 A Precise qNMR Method for the Rapid Quantification of Lot-to-Lot Variations in Multiple Quality Attributes of Pentosan Polysulfate Sodium Wang, Kai

25 3 article
4 Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum Dai, Yanshan

25 3 article
5 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 Sánchez, Javier

25 3 article
6 Dependence of Bioavailability on Mean Absorption Time: What Does It Tell Us? Weiss, Michael

25 3 article
7 Development of Drug Release Model for Suspensions in ESCAR (Emulator of SubCutaneous Absorption and Release) Lou, Hao

25 3 article
8 Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization Abend, Andreas M.

25 3 article
9 Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy Gorovits, Boris

25 3 article
10 Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets Tsume, Yasuhiro

25 3 article
11 InVitro-InVivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes Tess, David

25 3 article
12 Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics Purohit, Vivek

25 3 article
13 Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop Holm, René

25 3 article
14 Physiologically Based Pharmacokinetic Modeling to Characterize the Effect of Molecular Charge on Whole-Body Disposition of Monoclonal Antibodies Liu, Shufang

25 3 article
15 Plasma Stability and Plasma Metabolite Concentration–Time Profiles of Oligo(Lactic Acid)8-Paclitaxel Prodrug Loaded Polymeric Micelles Repp, Lauren

25 3 article
16 Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation Zou, Peng

25 3 article
17 Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point Zou, Peng

25 3 article
18 Quantitative Analysis of Gastrointestinal Water Dynamics by Means of a Physiologically Based Fluid Kinetic Model Suzuki, Satoru

25 3 article
19 Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal Garlits, John

25 3 article
20 The AAPS Journal Theme Issue: Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work Mora, Johanna R.

25 3 article
21 The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method Gao, Zongming

25 3 article
22 The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry Benet, Leslie Z.

25 3 article
23 Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling Mukherjee, Dwaipayan

25 3 article
                             23 results found
 
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