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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.
The FDA's assessment of follow-on protein products: a historical perspective.
Woodcock J, Griffin J, Behrman R, Cherney B, Crescenzi T, Fraser B, Hixon D, Joneckis C, Kozlowski S, Rosenberg A, Schrager L, Shacter E, Temple R, Webber K, Winkle H. Woodcock J, et al. Nat Rev Drug Discov. 2007 Jun;6(6):437-42. doi: 10.1038/nrd2307. Nat Rev Drug Discov. 2007. PMID: 17633790 Review.
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.
Advancing Product Quality: a Summary of the Second FDA/PQRI Conference.
Yu LX, Akseli I, Allen B, Amidon G, Bizjak TG, Boam A, Caulk M, Doleski D, Famulare J, Fisher AC, Furness S, Hasselbalch B, Havel H, Hoag SW, Iser R, Johnson BD, Ju R, Katz P, Lacana E, Lee SL, Lostritto R, McNally G, Mehta M, Mohan G, Nasr M, Nosal R, Oates M, O'Connor T, Polli J, Raju GK, Ramanadham M, Randazzo G, Rosencrance S, Schwendeman A, Selen A, Seo P, Shah V, Sood R, Thien MP, Tong T, Trout BL, Tyner K, Vaithiyalingam S, VanTrieste M, Walsh F, Wesdyk R, Woodcock J, Wu G, Wu L, Yu L, Zezza D. Yu LX, et al. Among authors: woodcock j. AAPS J. 2016 Mar;18(2):528-43. doi: 10.1208/s12248-016-9874-5. Epub 2016 Feb 9. AAPS J. 2016. PMID: 26860627 Free PMC article. No abstract available.
Biosimilars: The US Regulatory Framework.
Christl LA, Woodcock J, Kozlowski S. Christl LA, et al. Among authors: woodcock j. Annu Rev Med. 2017 Jan 14;68:243-254. doi: 10.1146/annurev-med-051215-031022. Epub 2016 Oct 28. Annu Rev Med. 2017. PMID: 27813877 Review.
Developing the nation's biosimilars program.
Kozlowski S, Woodcock J, Midthun K, Sherman RB. Kozlowski S, et al. Among authors: woodcock j. N Engl J Med. 2011 Aug 4;365(5):385-8. doi: 10.1056/NEJMp1107285. N Engl J Med. 2011. PMID: 21812668 No abstract available.
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.
523 results