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The AAPS Journal|February 3, 2019
Systemic Bioequivalence Is Unlikely to Equal Target Site Bioequivalence for Nanotechnology Oncologic ProductsJessie L-S Au, Ze Lu, Roberto A Abbiati, et al.
The AAPS Journal|February 10, 2019
Multiplexed Gene Expression as a Characterization of Bioactivity for Interferon Beta (IFN-β) Biosimilar Candidates: Impact of Innate Immune Response Modulating Impurities (IIRMIs)Eduardo F Mufarrege, Lydia A Haile, Marina Etcheverrigaray, et al.
The AAPS Journal|February 10, 2019
Estimation of Solid Tumor Doubling Times from Progression-Free Survival Plots Using a Novel Statistical ApproachKatherine Kay, Keith Dolcy, Robert Bies, et al.
The AAPS Journal|January 9, 2019
Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence PerspectiveQing Liu, Mohammad Absar, Bhawana Saluja, et al.
The AAPS Journal|March 15, 2018
Why Drugs Fail in Late Stages of Development: Case Study Analyses from the Last Decade and RecommendationsDolly A Parasrampuria, Leslie Z Benet, Amarnath Sharma
The AAPS Journal|March 15, 2018
A Simple Approach to Determine a Curve Fitting Model with a Correct Weighting Function for Calibration Curves in Quantitative Ligand Binding AssaysYuhong Xiang, Jean Donley, Elena Seletskaia, et al.
The AAPS Journal|March 16, 2018
Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of MoxifloxacinNikunjkumar Patel, Oliver Hatley, Alexander Berg, et al.
The AAPS Journal|November 29, 2018
The Assessment of Quality Attributes for Biosimilars: a Statistical Perspective on Current Practice and a ProposalJohanna Mielke, Franz Innerbichler, Martin Schiestl, et al.
The AAPS Journal|December 13, 2019
A Systems Pharmacology Model for Drug Delivery to Solid Tumors by Antibody-Drug Conjugates: Implications for Bystander EffectsJackson K Burton, Dean Bottino, Timothy W Secomb
The AAPS Journal|January 5, 2020
Model-Based Characterization of the Pharmacokinetics, Target Engagement Biomarkers, and Immunomodulatory Activity of PF-06342674, a Humanized mAb Against IL-7 Receptor-α, in Adults with Type 1 DiabetesJason H Williams, Chandrasekhar Udata, Bishu J Ganguly, et al.
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