Suchergebnisse - "Zineh, Issam"

PubPharm (7)

1

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

enthalten in: Clinical pharmacology and therapeutics | 2023

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

2

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

3

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

4

Considerations for Biologic Product Drug-Drug Interactions : A Regulatory Perspective

enthalten in: Clinical pharmacology and therapeutics | 2019

von Schrieber, S. | Pfuma-Fletcher, E. | Wang, X. | +5

5

Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins

enthalten in: Journal of pharmaceutical sciences | 2019

von Wang, Y. | Wang, Y. | Schrieber, S. | +5

6

Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States

enthalten in: Clinical pharmacology and therapeutics | 2018

von Dougherty, M. | Zineh, I. | Christl, L.

7

The Biosimilarity Concept : Toward an Integrated Framework for Evidence Assessment

enthalten in: Annals of internal medicine | 2016

von Zineh, I. | Christl, L.

CommentOn: Ann Intern Med. 2016 Oct 18;165(8):565-574. - PMID 27479870

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