Hi all, This week we will host Gregor Jordan and Roland Staack (Roche) to present and discuss on their recent publication, "Advancing Quantitative ADA Detection Through Model Informed Assay Development (MIAD)". They will share how MIAD can help optimize ...
ICH just posted a consolidated E6(R3): Good Clinical Practice Guideline combining the Principles document, Annex 1 and the recently adopted Annex 2. At 91 pages it will take several reads to understand all of it, but Annex 2 is loaded with information, ...
FDA released a final guidance - one with technical specifications on "Submitting Next-Generation Sequencing Data to the Division of Antivirals". The Agency notes that it does its own analysis and why: "The Division performs independent analyses of all ...
I am pleased to announce the "Emerging Graduate Student Highlights Webinar" sponsored by the AAPS Translational & Clinical Science Community . 📢 Call for Applications The AAPS Translational & Clinical Science Community invites ...
This is Revision 1 to the May 1998 guidance " Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products ", and is applicable to new drug applications (NDAs), biologics license applications (BLAs), or supplements to NDAs or BLAs ...
The Agency frames this 10-page guidance in the Introduction as "The focus of this guidance is on drugs for which the MABEL approach is recommended to guide starting doses for FIH trials. This can, but does not necessarily, include drugs that cause ...
For those following the NAM discussions in the US and EU, the EU has just advanced its position and plan in this Roadmap. The "Objectives of the Roadmap" section starts with a very clear set of statements on its intent: "This roadmap sets ...
This draft reflects changes based on comments submitted to the December 21, 2023 draft guidance that is for clinical trials operating under a master protocol. The introduction notes three examples of trial operating under a master protocol: umbrella, ...
Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Translational and Clinical Sciences Community on June 24, 12 pm – 1 pm EST on the following topic: AI for clinical biomarker discovery · Deep ...
This guidance is intended to provide the Agency’s recommendations on the appropriate use of a quantitative systems pharmacology (QSP)-based approach for determining minimum anticipated biological effect level (MABEL) dose in first-in-human (FIH), phase ...