Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, R. Bujalski, F. Qiu, Y. Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer, Donnie Pulliam
{"title":"在提交的监管文件中利用基于风险的预测稳定性;行业的经验","authors":"Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, R. Bujalski, F. Qiu, Y. Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer, Donnie Pulliam","doi":"10.1186/s41120-020-00034-7","DOIUrl":null,"url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":"59 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2020-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"10","resultStr":"{\"title\":\"Utilization of risk-based predictive stability within regulatory submissions; industry’s experience\",\"authors\":\"Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, R. Bujalski, F. Qiu, Y. Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer, Donnie Pulliam\",\"doi\":\"10.1186/s41120-020-00034-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\",\"PeriodicalId\":453,\"journal\":{\"name\":\"AAPS Open\",\"volume\":\"59 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-05-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"10\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"AAPS Open\",\"FirstCategoryId\":\"1\",\"ListUrlMain\":\"https://doi.org/10.1186/s41120-020-00034-7\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"AAPS Open","FirstCategoryId":"1","ListUrlMain":"https://doi.org/10.1186/s41120-020-00034-7","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}