David G Strauss (David Strauss)

Publication Activity (10 Years)

Years Active: 2018-2023
Publications (10 Years): 14

Top Topics

Drug Administration

Top Venues

Clinical pharmacology and therapeutics

Investigative and clinical urology

Therapeutic innovation & regulatory science

Toxicological sciences : an official journal of the Society of Toxicology

This page only lists publications with an associated author ORCID identifier.

Publications

Wendy W Wu, Moran Choe, Lars Johannesen, José Vicente, Girish Bende, Norman L Stockbridge, David G Strauss, Christine Garnett
ICH S7B in vitro assays do not address mechanisms of QT C prolongation for peptides and proteins - data in support of not needing dedicated QT C studies. Clinical pharmacology and therapeutics (2023)
Morasa Sheikhy, Sarah J Schrieber, Qin Sun, Victoria Gershuny, Murali K Matta, Jane P F Bai, Xiulian Du, Giri Vegesna, Aanchal Shah, Kristin Prentice, Colleen Nalepinski, Issam Zineh, Yow-Ming C Wang, David G Strauss, Jeffry Florian
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (I) A Randomized Trial with PCSK9 Inhibitors. Clinical pharmacology and therapeutics (2022)
Yow-Ming C Wang, David G Strauss
Advancing Innovations in Biosimilars. Clinical pharmacology and therapeutics 113 (1) (2022)
Mohammadreza Samieegohar, James L Weaver, Kristina E Howard, Anik Chaturbedi, John Mann, Xiaomei Han, Joel Zirkle, Ghazal Arabidarrehdor, Rodney Rouse, Jeffry Florian, David G Strauss, Zhihua Li
Calibration and Validation of a Mechanistic COVID-19 Model for Translational Quantitative Systems Pharmacology - A Proof-of-Concept Model Development for Remdesivir. Clinical pharmacology and therapeutics 112 (4) (2022)
Paula L Hyland, Lakshmi Manasa S Chekka, Deepti P Samarth, Barry A Rosenzweig, Erica Decker, Esraa G Mohamed, Yan Guo, Murali K Matta, Qin Sun, William Wheeler, Carlos Sanabria, James L Weaver, Sarah J Schrieber, Jeffry Florian, Yow-Ming C Wang, David G Strauss
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ-1a Biologics. Clinical pharmacology and therapeutics (2022)
David G Strauss, Yow-Ming C Wang, Jeffry Florian, Issam Zineh
Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval. Clinical pharmacology and therapeutics (2022)
Jeffry Florian, Victoria Gershuny, Qin Sun, Sarah J Schrieber, Murali K Matta, Anthony Hazel, Morasa Sheikhy, James L Weaver, Paula L Hyland, Cheng-Hui Hsiao, Giri Vegesna, Ryan DePalma, Aanchal Shah, Kristin Prentice, Carlos Sanabria, Yow-Ming C Wang, David G Strauss
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (III) A Randomized Trial with Interferon Beta-1a Products. Clinical pharmacology and therapeutics (2022)
Jeffry Florian, Qin Sun, Sarah J Schrieber, Richard White, Sophie Shubow, Bernadette E Johnson-Williams, Morasa Sheikhy, Nicholas R Harrison, Valerie J Parker, Yow-Ming C Wang, David G Strauss
Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary. Clinical pharmacology and therapeutics (2022)
Victoria Gershuny, Qin Sun, Sarah J Schrieber, Murali K Matta, James L Weaver, Ping Ji, Morasa Sheikhy, Cheng-Hui Hsiao, Giri Vegesna, Aanchal Shah, Kristin Prentice, Jennifer Deering, Yow-Ming C Wang, David G Strauss, Jeffry Florian
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (II) A Randomized Trial with IL-5 Antagonists. Clinical pharmacology and therapeutics (2022)
John Mann, Mohammadreza Samieegohar, Anik Chaturbedi, Joel Zirkle, Xiaomei Han, S Farzad Ahmadi, Amy Eshleman, Aaron Janowsky, Katherine Wolfrum, Tracy Swanson, Shelley Bloom, Albert Dahan, Erik Olofsen, Jeffry Florian, David G Strauss, Zhihua Li
Development of a Translational Model to Assess the Impact of Opioid Overdose and Naloxone Dosing on Respiratory Depression and Cardiac Arrest. Clinical pharmacology and therapeutics 112 (5) (2022)
Xi Yang, Alexandre J S Ribeiro, Li Pang, David G Strauss
Use of Human iPSC-CMs in Nonclinical Regulatory Studies for Cardiac Safety Assessment. Toxicological sciences : an official journal of the Society of Toxicology 190 (2) (2022)
Yow-Ming C Wang, David G Strauss
Advancing Innovations in Biosimilars. Clinical pharmacology and therapeutics 113 (1) (2022)
Matthew Lee, Ziho Lee, Helaine Koster, Minsuk Jun, Aeen M Asghar, Randall A Lee, David G Strauss, Neel Patel, Daniel Kim, Sreeya S Komaravolu, Alice Drain, Michael J Metro, Lee C Zhao, Michael Stifelman, Daniel D Eun, null null
Intermediate-term outcomes after robotic ureteral reconstruction for long-segment (≥4 centimeters) strictures in the proximal ureter: A multi-institutional experience. Investigative and clinical urology 62 (1) (2020)
David G Strauss, Gary Gintant, Zhihua Li, Wendy Wu, Ksenia Blinova, José Vicente, J Rick Turner, Philip T Sager
Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. Therapeutic innovation & regulatory science 53 (4) (2018)