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Page 1
Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned.
Mashingia JH, Ahonkhai V, Aineplan N, Ambali A, Angole A, Arik M, Azatyan S, Baak P, Bamenyekanye E, Bizoza A, Chamdimba C, Doerr P, Fimbo A, Gisagara A, Hamad H, Harris R, Hartman D, Kabatende J, Karangwa C, Kijo AS, Lumpkin M, Maboko S, Matle D, Muhairwe A, Mwesigye JP, Nyabenda B, Schulze A, Seiter A, Sematiko G, Sigonda M, Sillo H, Simai B, Siyoi F, Sonoiya S, Tanui P, Ward M, Yano F, Mukanga D. Mashingia JH, et al. Among authors: lumpkin m. PLoS Med. 2020 Aug 12;17(8):e1003134. doi: 10.1371/journal.pmed.1003134. eCollection 2020 Aug. PLoS Med. 2020. PMID: 32785219 Free PMC article. Review.
Coming together to improve access to medicines: The genesis of the East African Community's Medicines Regulatory Harmonization initiative.
Sillo H, Ambali A, Azatyan S, Chamdimba C, Kaale E, Kabatende J, Lumpkin M, Mashingia JH, Mukanga D, Nyabenda B, Sematiko G, Sigonda M, Simai B, Siyoi F, Sonoiya S, Ward M, Ahonkhai V. Sillo H, et al. Among authors: lumpkin m. PLoS Med. 2020 Aug 12;17(8):e1003133. doi: 10.1371/journal.pmed.1003133. eCollection 2020 Aug. PLoS Med. 2020. PMID: 32785273 Free PMC article. Review.
Scientific considerations for global drug development.
Wilson JL, Cheung KWK, Lin L, Green EAE, Porrás AI, Zou L, Mukanga D, Akpa PA, Darko DM, Yuan R, Ding S, Johnson WCN, Lee HA, Cooke E, Peck CC, Kern SE, Hartman D, Hayashi Y, Marks PW, Altman RB, Lumpkin MM, Giacomini KM, Blaschke TF. Wilson JL, et al. Among authors: lumpkin mm. Sci Transl Med. 2020 Jul 29;12(554):eaax2550. doi: 10.1126/scitranslmed.aax2550. Sci Transl Med. 2020. PMID: 32727913 Free PMC article. Review.
Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems.
Roth L, Bempong D, Babigumira JB, Banoo S, Cooke E, Jeffreys D, Kasonde L, Leufkens HGM, Lim JCW, Lumpkin M, Mahlangu G, Peeling RW, Rees H, Ndomondo-Sigonda M, Stergachis A, Ward M, Nwokike J. Roth L, et al. Among authors: lumpkin m. Global Health. 2018 Nov 1;14(1):102. doi: 10.1186/s12992-018-0421-2. Global Health. 2018. PMID: 30382856 Free PMC article. Review.
Adaptive licensing: taking the next step in the evolution of drug approval.
Eichler HG, Oye K, Baird LG, Abadie E, Brown J, Drum CL, Ferguson J, Garner S, Honig P, Hukkelhoven M, Lim JC, Lim R, Lumpkin MM, Neil G, O'Rourke B, Pezalla E, Shoda D, Seyfert-Margolis V, Sigal EV, Sobotka J, Tan D, Unger TF, Hirsch G. Eichler HG, et al. Among authors: lumpkin mm. Clin Pharmacol Ther. 2012 Mar;91(3):426-37. doi: 10.1038/clpt.2011.345. Epub 2012 Feb 15. Clin Pharmacol Ther. 2012. PMID: 22336591 Review.
From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G. Eichler HG, et al. Among authors: lumpkin m. Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4. Clin Pharmacol Ther. 2015. PMID: 25669457 Free PMC article.
132 results