Suchergebnisse - "Zineh, Issam"

PubPharm (234)

11

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

enthalten in: Clinical pharmacology and therapeutics | 2023

von Strauss, D. | Wang, Y. | Florian, J. | +1

12

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (I) A Randomized Trial with PCSK9 Inhibitors

enthalten in: Clinical pharmacology and therapeutics | 2023

von Sheikhy, M. | Schrieber, S. | Sun, Q. | +12

13

Model-Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development

enthalten in: Clinical pharmacology and therapeutics | 2023

von Li, F. | Sun, Q. | Du, S. | +5

14

Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development

enthalten in: Clinical Pharmacology & Therapeutics | 2023

von Li, F. | Sun, Q. | Du, S. | +5

15

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

enthalten in: Clinical Pharmacology & Therapeutics | 2023

von Strauss, D. | Wang, Y. | Florian, J. | +1

16

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (I) A Randomized Trial with PCSK9 Inhibitors

enthalten in: Clinical Pharmacology & Therapeutics | 2023

von Sheikhy, M. | Schrieber, S. | Sun, Q. | +12

17

US FDA Postmarketing Requirements and Commitments : A Systematic Assessment of Clinical Pharmacology Studies and Their Impact on US FDA Prescribing Information

enthalten in: The Journal of Clinical Pharmacology | 2023

von Ridge, S. | Guinn, D. | Pfuma Fletcher, E. | +3

18

A Multistakeholder Perspective on Advancing Individualized Therapeutics

enthalten in: Clinical Pharmacology & Therapeutics | 2023

von Pacanowski, M. | Vitarello, J. | Hyun, I. | +2

19

US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer

enthalten in: CPT: Pharmacometrics & Systems Pharmacology | 2023

von Shord, S. | Zhu, H. | Liu, J. | +3

20

Concentration-Response Model of Immediate Release Oxycodone Drug Liking by Different Routes of Abuse

enthalten in: Pain medicine (Malden, Mass.) | 2022

von Nallani, S. | Li, W. | Calderon, S. | +7