It is not new that FDA has accepted "In Silico" studies as alternative to in vitro and in vivo studies. And, I am sure FDA is looking at it closely for wider use since it is under pressure to find disruptive ways to accelerate new drug approval.
So, isn't good that PTX harnesses advanced ICT and put it in highly competitive position? Welcome to the new Industry 5.0 where Biotech merges with ICT!
------------------------------------
In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products - ScienceDirect
Highlights
•Regulators now consider also evidences produced in silico.
•We need accepted methods to evaluate the credibility of models.
•In this paper we describe the use of the ASME V&V-40 technical standard.
•We also discuss its application to various types of modelling methods.
In Silico Medicine Achievement so far:
2011:The U.S. Food and Drug Administration (FDA) approves T1DMS the first in silico diabetes type I model as a possible substitute for pre-clinical animal testing for new control strategies in Type 1 Diabetes Mellitus, to be used in artificial pancreas technologies.
2014:The U.S. Food and Drug Administration approves the first clinical technology based on subject-specific modelling: HeartFlow’s FFRCT software for measuring coronary blockages non-invasively.
