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Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints.
Orphanet J Rare Dis. 2015 Feb 10;10:16. doi: 10.1186/s13023-014-0195-4.
Orphanet J Rare Dis. 2015.
PMID: 25757705
Free PMC article.
Review.
Raising orphans: how clinical development programs of drugs for rare and common diseases are different.
Orfali M, Feldman L, Bhattacharjee V, Harkins P, Kadam S, Lo C, Ravi M, Shringarpure DT, Mardekian J, Cassino C, Coté T.
Orfali M, et al.
Clin Pharmacol Ther. 2012 Aug;92(2):262-4. doi: 10.1038/clpt.2012.87. Epub 2012 Jun 27.
Clin Pharmacol Ther. 2012.
PMID: 22739137
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Occult lumbosacral dysraphism in children and young adults: diagnostic performance of fast screening and conventional MR imaging.
Santiago Medina L, al-Orfali M, Zurakowski D, Poussaint TY, DiCanzio J, Barnes PD.
Santiago Medina L, et al. Among authors: al orfali m.
Radiology. 1999 Jun;211(3):767-71. doi: 10.1148/radiology.211.3.r99jn09767.
Radiology. 1999.
PMID: 10352604
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