التفاصيل البيبلوغرافية
العنوان:
Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpox
المؤلفون:
Kirk M Chan-Tack , Shirley Seo , Laine Myers , David McMillan , Su-Young Choi , Julian J. O'Rear , Patrick R. Harrington , Adam Sherwat , Debra Birnkrant , Hanan Ghantous
المصدر:
The Lancet Infectious Diseases . 19:e221-e224
بيانات النشر:
Elsevier BV, 2019.
سنة النشر:
2019
مصطلحات موضوعية:
0301 basic medicine , Drug , medicine.medical_specialty , media_common.quotation_subject , MEDLINE , Disease , Isoindoles , Antiviral Agents , Food and drug administration , 03 medical and health sciences , 0302 clinical medicine , medicine , Humans , Smallpox , 030212 general & internal medicine , Disease Eradication , Intensive care medicine , Drug Approval , media_common , United States Food and Drug Administration , business.industry , Tecovirimat , medicine.disease , United States , Treatment Outcome , 030104 developmental biology , Infectious Diseases , Benzamides , Regulatory Pathway , business
الوصف:
The development and ultimate approval of tecovirimat for the antiviral treatment of smallpox, a disease that has been eradicated from the world for nearly 40 years, required a unique regulatory approach based on the US Food and Drug Administration's Animal Rule. We summarise the regulatory pathway and describe the challenges involved.
تدمد:
1473-3099
URL الوصول:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::856e39dcdb98184a25ad65d47ef931fb https://doi.org/10.1016/s1473-3099 (18)30788-6
حقوق:
CLOSED
رقم الأكسشن:
edsair.doi.dedup.....856e39dcdb98184a25ad65d47ef931fb
قاعدة البيانات:
OpenAIRE