Physicochemical and Formulation Developability Assessment for Therapeutic Peptide Delivery—A Primer Journal title: The AAPS Journal Authors: Annette Bak, Dennis Leung, Stephanie E. Barrett, Seth Forster, Ellen C. Minnihan, Andrew W. Leithead... Subject(s): Medicine
Antibody Drug Conjugates: Design and Selection of Linker, Payload and Conjugation Chemistry Journal title: The AAPS Journal Authors: Jessica R. McCombs, Shawn C. Owen Subject(s): Medicine
In Silico Evaluation of the Potential Impact of Bioanalytical Bias Difference between Two Therapeutic Protein Formulations for Pharmacokinetic Assessment in a Biocomparability Study Journal title: The AAPS Journal Authors: Theingi M. Thway, Chris Macaraeg, Michael Eschenberg, Mark Ma Subject(s): Medicine
A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion Journal title: The AAPS Journal Authors: Wenlei Jiang, Fairouz Makhlouf, Donald J. Schuirmann, Xinyuan Zhang, Nan Zheng, Dale Conner, Lawrenc... Subject(s): Medicine
Antibody Drug Conjugates: Nonclinical Safety Considerations Journal title: The AAPS Journal Authors: Mary Jane Masson Hinrichs, Rakesh Dixit Subject(s): Medicine
Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges Journal title: The AAPS Journal Authors: Hong Wen, Huijeong Jung, Xuhong Li Subject(s): Medicine
Development of a Generic Anti-PEG Antibody Assay Using BioScale’s Acoustic Membrane MicroParticle Technology Journal title: The AAPS Journal Authors: Huijin Dong, Johanna R. Mora, Catherine Brockus, Shannon D. Chilewski, Robert Dodge, Colin Merrifiel... Subject(s): Medicine
Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team Journal title: The AAPS Journal Authors: Sherri Dudal, Daniel Baltrukonis, Rebecca Crisino, M. Jaya Goyal, Alison Joyce, Karolina Öst... Subject(s): Medicine
Determination of the Most Influential Sources of Variability in Tacrolimus Trough Blood Concentrations in Adult Liver Transplant Recipients: A Bottom-Up Approach Journal title: The AAPS Journal Authors: Cécile Gérard, Jeanick Stocco, Anne Hulin, Benoit Blanchet, Céline Verstuyft... Subject(s): Medicine
Simultaneous Analysis of Multiple Monoclonal Antibody Biotherapeutics by LC-MS/MS Method in Rat Plasma Following Cassette-Dosing Journal title: The AAPS Journal Authors: Hongyan Li, Robert Ortiz, Linh T. B. Tran, Hossein Salimi-Moosavi, Jennifer Malella, Christopher A.... Subject(s): Medicine
Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation Journal title: The AAPS Journal Authors: Marian Kelley, Ago B. Ahene, Boris Gorovits, John Kamerud, Lindsay E. King, Thomas McIntosh, Jihong... Subject(s): Medicine
Impact of Anti-Drug Antibodies in Preclinical Pharmacokinetic Assessment Journal title: The AAPS Journal Authors: Theingi M. Thway, Ivan Magana, Ami Bautista, Vibha Jawa, Wen Gu, Mark Ma Subject(s): Medicine
Immunogenicity of Subcutaneously Administered Therapeutic Proteins—a Mechanistic Perspective Journal title: The AAPS Journal Authors: Anas M. Fathallah, Richard B. Bankert, Sathy V. Balu-Iyer Subject(s): Medicine
Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop Journal title: The AAPS Journal Authors: Jane R. Kenny, Maggie M. Liu, Andrew T. Chow, Justin C. Earp, Raymond Evers, J. Greg Slatter, Diane... Subject(s): Medicine
A Mathematical Model of the Effect of Immunogenicity on Therapeutic Protein Pharmacokinetics Journal title: The AAPS Journal Authors: Xiaoying Chen, Timothy Hickling, Eugenia Kraynov, Bing Kuang, Chuenlei Parng, Paolo Vicini Subject(s): Medicine
