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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
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.
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.
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
Understanding pharmaceutical quality by design.
Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock J. Yu LX, et al. Among authors: woodcock j. AAPS J. 2014 Jul;16(4):771-83. doi: 10.1208/s12248-014-9598-3. Epub 2014 May 23. AAPS J. 2014. PMID: 24854893 Free PMC article. Review.
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: woodcock j. 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.
522 results