Suchergebnisse - "Zineh, Issam"

PubPharm (234)

21

Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance

enthalten in: EClinicalMedicine | 2021

von Zhao, L. | Li, Z. | Fang, L. | +8

22

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary

enthalten in: CPT: pharmacometrics & systems pharmacology | 2021

von Jean, D. | Naik, K. | Milligan, L. | +18

23

Evaluating Patients With Impaired Renal Function During Drug Development : Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting

enthalten in: Clinical pharmacology and therapeutics | 2021

von Sahre, M. | Milligan, L. | Madabushi, R. | +9

24

Precision Dosing : A Clinical and Public Health Imperative

enthalten in: JAMA | 2021

von Maxfield, K. | Zineh, I.

25

Elucidating the Impact of Immunogenicity Assessment Postapproval : A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments

enthalten in: Clinical pharmacology and therapeutics | 2021

von Guinn, D. | Madabushi, R. | Wang, Y. | +2

26

Proceedings of a Workshop : Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting

enthalten in: Clinical pharmacology and therapeutics | 2021

von Maxfield, K. | Milligan, L. | Wang, L. | +8

27

Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug-Drug Interaction Risks

enthalten in: Clinical pharmacology and therapeutics | 2021

von Yang, X. | Pfuma Fletcher, E. | Huang, S. | +2

28

A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response-Guided Titration

enthalten in: Clinical pharmacology and therapeutics | 2021

von Wang, L. | Maxfield, K. | Guinn, D. | +3

29

Proceedings of a Workshop : Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting

enthalten in: Clinical Pharmacology & Therapeutics | 2021

von Maxfield, K. | Milligan, L. | Wang, L. | +8

30

Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug‐Drug Interaction Risks

enthalten in: Clinical Pharmacology & Therapeutics | 2021

von Yang, X. | Pfuma Fletcher, E. | Huang, S. | +2