Translational and Clinical Science Community

Thread Subject	Replies	Views	Last Post
FDA posts draft guidance "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials"	0	2	2 days ago by Mark Arnold
EU Commission "Roadmap towards phasing out animal testing for chemical safety assessments"	0	2	2 days ago by Mark Arnold
FDA posted a revised draft guidance "Master Protocols for Drug and Biological Product Development".	0	1	3 days ago by Mark Arnold
Reminder of the OSD on ML/AI for Clnical Biomarkers, June 24, 12 pm - 1 pm EST	0	2	3 days ago by Carmen Fernandez-Metzler
FDA Guidance on QSP- based dose selection for MABEL First-in-Human (FIH) Trials	0	9	4 days ago by Md Masud Parvez
FDA final guidance "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug"	0	5	8 days ago by Mark Arnold
OSD on AI Approaches for Biomarker Discovery and Precision Medicine_24Jun2026	0	8	17 days ago by Carmen Fernandez-Metzler
Multi Parameter Biomarker Platforms	5	46	20 days ago by Sally Fischer Original post by Wendy Adamowicz
OSD: Viral Shedding Profiles of Approved AAV Gene Therapy – What Have We Learned?	0	6	21 days ago by Yan Ni
Advancing Human-Relevant Preclinical Testing Through New Approach Methodologies	0	5	22 days ago by Sudip Das

Showing 1 to 10 of 27 threads (27 total posts)