Parekh A - Search Results

1

Catalyzing the Critical Path Initiative: FDA's progress in drug development activities.

Parekh A, Buckman-Garner S, McCune S, ONeill R, Geanacopoulos M, Amur S, Clingman C, Barratt R, Rocca M, Hills I, Woodcock J. Parekh A, et al. Clin Pharmacol Ther. 2015 Mar;97(3):221-33. doi: 10.1002/cpt.42. Epub 2015 Jan 28. Clin Pharmacol Ther. 2015. PMID: 25670629

2

The Role of Public-Private Partnerships in Catalyzing the Critical Path.

Maxfield KE, Buckman-Garner S, Parekh A. Maxfield KE, et al. Among authors: parekh a. Clin Transl Sci. 2017 Nov;10(6):431-442. doi: 10.1111/cts.12488. Epub 2017 Aug 3. Clin Transl Sci. 2017. PMID: 28776943 Free PMC article. Review. No abstract available.

3

Sex differences and genomics in autoimmune diseases.

Amur S, Parekh A, Mummaneni P. Amur S, et al. Among authors: parekh a. J Autoimmun. 2012 May;38(2-3):J254-65. doi: 10.1016/j.jaut.2011.12.001. Epub 2011 Dec 27. J Autoimmun. 2012. PMID: 22204900 Review.

4

Adverse effects in women: implications for drug development and regulatory policies.

Parekh A, Fadiran EO, Uhl K, Throckmorton DC. Parekh A, et al. Expert Rev Clin Pharmacol. 2011 Jul;4(4):453-66. doi: 10.1586/ecp.11.29. Expert Rev Clin Pharmacol. 2011. PMID: 22114855 Review.

5

Public-private partnerships in transplant drug development.

Albrecht R, Papadopoulos EJ, Campbell M, Daniels S, Kluetz PG, Parekh A, Wang Y. Albrecht R, et al. Among authors: parekh a. Am J Transplant. 2020 Feb;20(2):377-381. doi: 10.1111/ajt.15604. Epub 2019 Oct 30. Am J Transplant. 2020. PMID: 31553120 Free article.

6

Females in clinical studies: where are we going?

Uhl K, Parekh A, Kweder S. Uhl K, et al. Among authors: parekh a. Clin Pharmacol Ther. 2007 Apr;81(4):600-2. doi: 10.1038/sj.clpt.6100112. Epub 2007 Feb 21. Clin Pharmacol Ther. 2007. PMID: 17314925

7

Population pharmacokinetic and concentration--QTc models for moxifloxacin: pooled analysis of 20 thorough QT studies.

Florian JA, Tornøe CW, Brundage R, Parekh A, Garnett CE. Florian JA, et al. Among authors: parekh a. J Clin Pharmacol. 2011 Aug;51(8):1152-62. doi: 10.1177/0091270010381498. Epub 2011 Jan 12. J Clin Pharmacol. 2011. PMID: 21228407

8

Value of Data Sharing to Advance Drug Development: A Regulatory Perspective.

Thompson A, Parekh A. Thompson A, et al. Among authors: parekh a. Ther Innov Regul Sci. 2021 Jul;55(4):850-852. doi: 10.1007/s43441-021-00275-y. Epub 2021 Apr 19. Ther Innov Regul Sci. 2021. PMID: 33876396

9

Participation of women and sex analyses in late-phase clinical trials of new molecular entity drugs and biologics approved by the FDA in 2007-2009.

Poon R, Khanijow K, Umarjee S, Fadiran E, Yu M, Zhang L, Parekh A. Poon R, et al. Among authors: parekh a. J Womens Health (Larchmt). 2013 Jul;22(7):604-16. doi: 10.1089/jwh.2012.3753. Epub 2013 Jun 14. J Womens Health (Larchmt). 2013. PMID: 23768021 Free PMC article.

10

Advancing women's health via FDA Critical Path Initiative.

Parekh A, Sanhai W, Marts S, Uhl K. Parekh A, et al. Drug Discov Today Technol. 2007 Winter;4(2):69-73. doi: 10.1016/j.ddtec.2007.10.014. Drug Discov Today Technol. 2007. PMID: 24980844

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