tag:blogger.com,1999:blog-15654301.post8698001809528984660..comments2024-02-24T04:43:56.829-05:00Comments on On Biostatistics and Clinical Trials: The Size of Safety Database In Drug Development ProgramWeb blog from Dr. Denghttp://www.blogger.com/profile/11917138094035874938noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-15654301.post-59637768515945464422023-02-22T18:07:41.762-05:002023-02-22T18:07:41.762-05:00Thank you for such an informative resource. I have...Thank you for such an informative resource. I have a specific question related to safety database requirements for a combination product (3 novel molecules) at the time of accelerated approval. I am curious to know if historical safety data obtained from subjects in previous trials generated for each separate component could be used to add to the required number of approximately 1500 patients that FDA and ICH recommend.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-15654301.post-53060221792371355152023-01-12T03:51:16.959-05:002023-01-12T03:51:16.959-05:00This is a fantastic essay with tonnes of useful in...This is a fantastic essay with tonnes of useful information. The quantity of the safety database utilized in drug discovery is explained in detail in this blog. The size of the safety database may differ depending on the area being developed. During the meeting with the FDA, the size of the safety database is typically mentioned. I appreciate your amazing and comprehensive explanation.<br />Sollers Collegehttp://onbiostatistics.blogspot.com/2013/05/the-size-of-safety-database-in-drug.htmlnoreply@blogger.comtag:blogger.com,1999:blog-15654301.post-92055307495751762572019-07-05T23:53:08.842-04:002019-07-05T23:53:08.842-04:00Thank you for your wonderful and clear explanation...Thank you for your wonderful and clear explanation! Could you provide the source where FDA accepted a minimum of 300-400 subjects as the safety database to support an indication in the intended use population(s) to rule out with 95% confidence an adverse event that occurs with a frequency of 1%?Sherryhttps://www.blogger.com/profile/09802799341242654776noreply@blogger.comtag:blogger.com,1999:blog-15654301.post-86104992061857859792017-07-31T11:40:46.761-04:002017-07-31T11:40:46.761-04:00Very helpful! Thanks!Very helpful! Thanks!X Zhangnoreply@blogger.com