Zineh I - Search Results

1

Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.

Schuck RN, Woodcock J, Zineh I, Stein P, Jarow J, Temple R, Permutt T, LaVange L, Beaver JA, Charlab R, Blumenthal GM, Dorff SE, Leptak C, Lemery S, Rogers H, Chowdhury B, Litwack ED, Pacanowski M. Schuck RN, et al. Among authors: zineh i. Clin Pharmacol Ther. 2018 Aug;104(2):282-289. doi: 10.1002/cpt.1041. Epub 2018 Feb 23. Clin Pharmacol Ther. 2018. PMID: 29473145 Free PMC article. Review.

2

Clinical pharmacology and the catalysis of regulatory science: opportunities for the advancement of drug development and evaluation.

Zineh I, Woodcock J. Zineh I, et al. Clin Pharmacol Ther. 2013 Jun;93(6):515-25. doi: 10.1038/clpt.2013.32. Epub 2013 Feb 12. Clin Pharmacol Ther. 2013. PMID: 23571772

3

Next-generation medicines: past regulatory experience and considerations for the future.

Pacanowski MA, Leptak C, Zineh I. Pacanowski MA, et al. Among authors: zineh i. Clin Pharmacol Ther. 2014 Mar;95(3):247-9. doi: 10.1038/clpt.2013.222. Clin Pharmacol Ther. 2014. PMID: 24548989 Review.

4

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.

Green DJ, Liu XI, Hua T, Burnham JM, Schuck R, Pacanowski M, Yao L, McCune SK, Burckart GJ, Zineh I. Green DJ, et al. Among authors: zineh i. Clin Pharmacol Ther. 2018 Nov;104(5):983-988. doi: 10.1002/cpt.971. Epub 2018 Feb 13. Clin Pharmacol Ther. 2018. PMID: 29218740 Free PMC article.

5

Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease.

Schuck RN, Pacanowski M, Woodcock J, Zineh I. Schuck RN, et al. Among authors: zineh i. Nat Rev Drug Discov. 2018 Feb;17(2):79-80. doi: 10.1038/nrd.2017.231. Epub 2017 Dec 22. Nat Rev Drug Discov. 2018. PMID: 29269943 No abstract available.

6

An Overview of Genomic Biomarker Use in Cardiovascular Disease Clinical Trials.

Adeniyi O, Ramamoorthy A, Schuck R, Sun J, Wilson J, Zineh I, Pacanowski M. Adeniyi O, et al. Among authors: zineh i. Clin Pharmacol Ther. 2019 Oct;106(4):841-846. doi: 10.1002/cpt.1473. Epub 2019 Jun 20. Clin Pharmacol Ther. 2019. PMID: 31002380

7

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

Wang L, Maxfield K, Guinn D, Madabushi R, Zineh I, Schuck RN. Wang L, et al. Among authors: zineh i. Clin Pharmacol Ther. 2021 Jan;109(1):123-130. doi: 10.1002/cpt.2068. Epub 2020 Nov 15. Clin Pharmacol Ther. 2021. PMID: 33022770 Free PMC article.

8

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.

Amur S, LaVange L, Zineh I, Buckman-Garner S, Woodcock J. Amur S, et al. Among authors: zineh i. Clin Pharmacol Ther. 2015 Jul;98(1):34-46. doi: 10.1002/cpt.136. Epub 2015 Jun 6. Clin Pharmacol Ther. 2015. PMID: 25868461 Review.

9

CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations.

Rogers HL, Bhattaram A, Zineh I, Gobburu J, Mathis M, Laughren TP, Pacanowski M. Rogers HL, et al. Among authors: zineh i. J Clin Psychiatry. 2012 Sep;73(9):1187-90. doi: 10.4088/JCP.11m07572. J Clin Psychiatry. 2012. PMID: 23059146

10

Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration-Approved Drugs.

Schuck RN, Pacanowski M, Kim S, Madabushi R, Zineh I. Schuck RN, et al. Among authors: zineh i. Clin Transl Sci. 2019 May;12(3):236-239. doi: 10.1111/cts.12626. Epub 2019 Mar 12. Clin Transl Sci. 2019. PMID: 30791226 Free PMC article.

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