1. Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies. Issue 1 (31st October 2019) Authors: Li, Junyi; Florian, Jeffry; Campbell, Elizabeth; Schrieber, Sarah J.; Bai, Jane P.F.; Weaver, James L.; Hyland, Paula L.; Thway, Theingi M.; Matta, Murali K.; Lankapalli, Rachana H.; Narayanasamy, Suresh; Dancy, Jimena; Zusterzeel, Robbert; Tyson, Jessica Y.; Prentice, Kristin W.; Jackson, Kathry... Journal: Clinical pharmacology & therapeutics Issue: Volume 107:Issue 1(2020) Page Start: 40 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. Benefit‐Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments. (7th September 2017) Authors: Florian, Jeffry; Zhuang, Ada Journal: CPT: pharmacometrics & systems pharmacology Issue: Volume 6:Number 11(2017) Page Start: 725 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Boceprevir dosing for late responders and null responders: The role of bridging data between treatment‐naïve and ‐experienced subjects. Issue 3 (29th January 2013) Authors: Florian, Jeffry; Jadhav, Pravin R.; Amur, Shashi; Ayala, Ruben; Harrington, Patrick; Mishra, Poonam; O'Rear, Jules; Pacanowski, Michael; Robertson, Sarah; Singer, Mary; Soon, Greg; Zeng, Wen; Murray, Jeffrey Journal: Hepatology Issue: Volume 57:Issue 3(2013:Mar.) Page Start: 903 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Boceprevir dosing for late responders and null responders: The role of bridging data between treatment‐naïve and ‐experienced subjects1234. Issue 3 (29th January 2013) Authors: Florian, Jeffry; Jadhav, Pravin R.; Amur, Shashi; Ayala, Ruben; Harrington, Patrick; Mishra, Poonam; O'Rear, Jules; Pacanowski, Michael; Robertson, Sarah; Singer, Mary; Soon, Greg; Zeng, Wen; Murray, Jeffrey Journal: Hepatology Issue: Volume 57:Issue 3(2013:Mar.) Page Start: 903 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Calibration and Validation of a Mechanistic COVID‐19 Model for Translational Quantitative Systems Pharmacology – A Proof‐of‐Concept Model Development for Remdesivir. Issue 4 (29th June 2022) Authors: Samieegohar, Mohammadreza; Weaver, James L.; Howard, Kristina E.; Chaturbedi, Anik; Mann, John; Han, Xiaomei; Zirkle, Joel; Arabidarrehdor, Ghazal; Rouse, Rodney; Florian, Jeffry; Strauss, David G.; Li, Zhihua Journal: Clinical pharmacology & therapeutics Issue: Volume 112:Issue 4(2022) Page Start: 882 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation. (10th November 2019) Authors: Kuemmel, Colleen; Yang, Yuching; Zhang, Xinyuan; Florian, Jeffry; Zhu, Hao; Tegenge, Million; Huang, Shiew‐Mei; Wang, Yaning; Morrison, Tina; Zineh, Issam Journal: CPT: pharmacometrics & systems pharmacology Issue: Volume 9:Number 1(2020) Page Start: 21 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (I) A Randomized Trial with PCSK9 Inhibitors. Issue 1 (15th November 2022) Authors: Sheikhy, Morasa; Schrieber, Sarah J.; Sun, Qin; Gershuny, Victoria; Matta, Murali K.; Bai, Jane P.F.; Du, Xiulian; Vegesna, Giri; Shah, Aanchal; Prentice, Kristin; Nalepinski, Colleen; Zineh, Issam; Wang, Yow‐Ming; Strauss, David G.; Florian, Jeffry Journal: Clinical pharmacology & therapeutics Issue: Volume 113:Issue 1(2023) Page Start: 71 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (III) A Randomized Trial with Interferon Beta‐1a Products. Issue 2 (2nd December 2022) Authors: Florian, Jeffry; Gershuny, Victoria; Sun, Qin; Schrieber, Sarah J.; Matta, Murali K.; Hazel, Anthony; Sheikhy, Morasa; Weaver, James L.; Hyland, Paula L.; Hsiao, Cheng‐Hui; Vegesna, Giri; DePalma, Ryan; Shah, Aanchal; Prentice, Kristin; Sanabria, Carlos; Wang, Yow‐Ming; Strauss, David G. Journal: Clinical pharmacology & therapeutics Issue: Volume 113:Issue 2(2023) Page Start: 339 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. Development of a Translational Model to Assess the Impact of Opioid Overdose and Naloxone Dosing on Respiratory Depression and Cardiac Arrest. Issue 5 (22nd July 2022) Authors: Mann, John; Samieegohar, Mohammadreza; Chaturbedi, Anik; Zirkle, Joel; Han, Xiaomei; Ahmadi, S. Farzad; Eshleman, Amy; Janowsky, Aaron; Wolfrum, Katherine; Swanson, Tracy; Bloom, Shelley; Dahan, Albert; Olofsen, Erik; Florian, Jeffry; Strauss, David G.; Li, Zhihua Journal: Clinical pharmacology & therapeutics Issue: Volume 112:Issue 5(2022) Page Start: 1020 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. Does an Increase in Serum Creatinine always Reflect Renal Injury? The Case of Stribild®. (25th November 2013) Authors: Arya, Vikram; Florian, Jeffry; Marcus, Kendall A.; Reynolds, Kellie S.; Lewis, Linda L.; Sherwat, Adam I. Journal: Journal of clinical pharmacology Issue: Volume 54:Number 3(2014:Mar.) Page Start: 279 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗