An update on the therapeutic orphan.
نویسنده
چکیده
ABBREVIATIONS. FDA, US Food and Drug Administration; NDA, new drug application; PDR, Physicians Desk Reference; NME, new molecular entity; AAP, American Academy of Pediatrics; COD, Committee on Drugs; OPD, orphan products development; USP, US Pharmacopeia; USP-DI, US Pharmacopoeia–Drug Information; PhRMA, Pharmaceutical Research and Manufacturers Association; NIH, National Institutes of Health; PPRU, Pediatric Pharmacology Research Unit; NICHD, National Institute of Child Health and Human Development; OTC, over the counter; NP–PDR, Non-Prescription Physicians’ Desk Reference.
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ورودعنوان ژورنال:
- Pediatrics
دوره 104 3 Pt 2 شماره
صفحات -
تاریخ انتشار 1999