Module 9 2024

03/09/2024

Nonclinical testing of biologics

High level definition of requirements in several guidelines…

And…. other local National Health Authorities es

These need to be converted into the best toxicology package for the individual molecule

The Organisation for Professionals in Regulatory Affairs

Preclinical Testing of Biologicals – Sept 2024

7

Nonclinical testing of biologics

N.B Recent change in legislation by FDA has been massively over-interpreted in the media…

In reality, this was a long overdue change as the previous legislation stated that new drugs MUST be tested on animals before human trials…. The new wording simply opens the door for novel alternative methods to support registration …..but only IF the NAM is a validated and scientifically sound alternative and the limitations are well known and understood…..

The Organisation for Professionals in Regulatory Affairs

Preclinical Testing of Biologicals – Sept 2024

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