|
|
Click to share this burst with your friends and colleagues! 
THE RIGHT TREATMENT | FOR THE RIGHT PATIENT | AT THE RIGHT TIME | EVERY TIME
|
|
FDA Publishes Draft Guidance Entitled “Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials” |
|
|
On June 22, the U.S. Food and Drug Administration (FDA) published the draft guidance entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials."
Selecting an appropriate initial dose for FIH trials is a critical step. In the past decade, QSP has emerged as a modeling approach that can be used in regulatory submissions to evaluate complex drug-biological system interactions. By integrating biology and exposure-response understanding, QSP can inform FIH dose selection and dose escalation. The use of QSP modeling for this purpose also aligns with FDA’s broader strategy to reduce reliance on animal studies.
FDA seeks feedback on this guidance document. Please refer to the notice in the Federal Register for submission information.
|
|
|
The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today or click the button below and select Clinical Pharmacology Corner under Drugs.
We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.
This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
|
|
|
|
