Woodcock J - Search Results

1

Novel bioequivalence approach for narrow therapeutic index drugs.

Yu LX, Jiang W, Zhang X, Lionberger R, Makhlouf F, Schuirmann DJ, Muldowney L, Chen ML, Davit B, Conner D, Woodcock J. Yu LX, et al. Among authors: woodcock j. Clin Pharmacol Ther. 2015 Mar;97(3):286-91. doi: 10.1002/cpt.28. Epub 2014 Dec 15. Clin Pharmacol Ther. 2015. PMID: 25669762

2

Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.

Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, Yang Y, Yu LX, Woodcock J. Davit BM, et al. Among authors: woodcock j. Ann Pharmacother. 2009 Oct;43(10):1583-97. doi: 10.1345/aph.1M141. Epub 2009 Sep 23. Ann Pharmacother. 2009. PMID: 19776300

3

Withdrawal of generic budeprion for nonbioequivalence.

Woodcock J, Khan M, Yu LX. Woodcock J, et al. N Engl J Med. 2012 Dec 27;367(26):2463-5. doi: 10.1056/NEJMp1212969. Epub 2012 Dec 5. N Engl J Med. 2012. PMID: 23216549 No abstract available.

4

FDA pharmaceutical quality oversight.

Yu LX, Woodcock J. Yu LX, et al. Among authors: woodcock j. Int J Pharm. 2015 Aug 1;491(1-2):2-7. doi: 10.1016/j.ijpharm.2015.05.066. Epub 2015 May 29. Int J Pharm. 2015. PMID: 26027494 Review.

5

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.

Adams WP, Ahrens RC, Chen ML, Christopher D, Chowdhury BA, Conner DP, Dalby R, Fitzgerald K, Hendeles L, Hickey AJ, Hochhaus G, Laube BL, Lucas P, Lee SL, Lyapustina S, Li B, O'Connor D, Parikh N, Parkins DA, Peri P, Pitcairn GR, Riebe M, Roy P, Shah T, Singh GJ, Sharp SS, Suman JD, Weda M, Woodcock J, Yu L. Adams WP, et al. Among authors: woodcock j. J Aerosol Med Pulm Drug Deliv. 2010 Feb;23(1):1-29. doi: 10.1089/jamp.2009.0803. J Aerosol Med Pulm Drug Deliv. 2010. PMID: 20131983

6

Scientific considerations in the review and approval of generic enoxaparin in the United States.

Lee S, Raw A, Yu L, Lionberger R, Ya N, Verthelyi D, Rosenberg A, Kozlowski S, Webber K, Woodcock J. Lee S, et al. Among authors: woodcock j. Nat Biotechnol. 2013 Mar;31(3):220-6. doi: 10.1038/nbt.2528. Nat Biotechnol. 2013. PMID: 23471071

7

Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.

Mehta MU, Uppoor RS, Conner DP, Seo P, Vaidyanathan J, Volpe DA, Stier E, Chilukuri D, Dorantes A, Ghosh T, Mandula H, Raines K, Dhanormchitphong P, Woodcock J, Yu LX. Mehta MU, et al. Among authors: woodcock j. Mol Pharm. 2017 Dec 4;14(12):4334-4338. doi: 10.1021/acs.molpharmaceut.7b00687. Epub 2017 Nov 7. Mol Pharm. 2017. PMID: 29076742

8

Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

Fisher AC, Lee SL, Harris DP, Buhse L, Kozlowski S, Yu L, Kopcha M, Woodcock J. Fisher AC, et al. Among authors: woodcock j. Int J Pharm. 2016 Dec 30;515(1-2):390-402. doi: 10.1016/j.ijpharm.2016.10.038. Epub 2016 Oct 20. Int J Pharm. 2016. PMID: 27773853 Review.

9

The FDA's Approach to the Prescription Opioid Problem.

Woodcock J, Throckmorton DC. Woodcock J, et al. Clin Pharmacol Ther. 2018 Jun;103(6):954-955. doi: 10.1002/cpt.1055. Epub 2018 Mar 23. Clin Pharmacol Ther. 2018. PMID: 29570773

10

Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma.

Raju GK, Gurumurthi K, Domike R, Theoret MR, Pazdur R, Woodcock J. Raju GK, et al. Among authors: woodcock j. Clin Pharmacol Ther. 2019 Jul;106(1):123-135. doi: 10.1002/cpt.1461. Epub 2019 May 21. Clin Pharmacol Ther. 2019. PMID: 30993685

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