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Author/Creator Zineh, Issam

2. Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration. Issue 5 (13th February 2018)

Authors:
Green, Dionna J.; Liu, Xiaomei I.; Hua, Tianyi; Burnham, Janelle M.; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K.; Burckart, Gilbert J.; Zineh, Issam
Journal:
Clinical pharmacology & therapeutics
Issue:
Volume 104:Issue 5(2018)
Page Start:
983
Record Type:
Journal Article
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4. 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
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6. Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy‐Induced Nausea and Vomiting. (22nd January 2020)

Authors:
Momper, Jeremiah D.; Heinrichs, M. Tobias; Krudys, Kevin; Griebel, Donna; Kumar, Shaun; Kim, Insook; Mehrotra, Nitin; Mulberg, Andrew E.; Garimella, Narayana; Nelson, Robert; Reaman, Gregory; Sinha, Vikram; Yao, Lynne; Zineh, Issam; Burckart, Gilbert; Sachs, Hari; Mulugeta, Yeruk
Journal:
Journal of clinical pharmacology
Issue:
Volume 60:Number 6(2020)
Page Start:
775
Record Type:
Journal Article
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8. Proceedings of a Workshop: US Food and Drug Administration‐International Society of Pharmacometrics Model‐Informed Drug Development in Oncology. Issue 1 (5th April 2019)

Authors:
Bruno, Rene; Jin, Jin Y.; Maxfield, Kimberly; Milligan, Lauren; Liu, Chao; Wang, Yaning; McKee, Amy E.; Zineh, Issam
Journal:
Clinical pharmacology & therapeutics
Issue:
Volume 106:Issue 1(2019)
Page Start:
81
Record Type:
Journal Article
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9. The US Food and Drug Administration's Model‐Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact. Issue 1 (13th May 2019)

Authors:
Madabushi, Rajanikanth; Benjamin, Jessica M.; Grewal, Renmeet; Pacanowski, Michael A.; Strauss, David G.; Wang, Yaning; Zhu, Hao; Zineh, Issam
Journal:
Clinical pharmacology & therapeutics
Issue:
Volume 106:Issue 1(2019)
Page Start:
74
Record Type:
Journal Article
View Content:
Available online (eLD content is only available in our Reading Rooms) ↗