Taking the leap toward human-specific nonanimal methodologies: The need for harmonizing global policies for microphysiological systems
Surat Parvatam, David Pamies, Francesca Pistollato, Sonja Beken, Indumathi Mariappan, Adrian Roth, Monica Piergiovanni, B. G. C. Maisonneuve, Lorna Ewart, Abhijit Majumder, Prajakta Dandekar, Rahul Date, Kasturi Mahadik, Saravanan Thiyagarajan, Sandra Coecke
Abstract
With a recent amendment, India joined other countries that have removed the legislative barrier toward the use of human-relevant methods in drug development. Here, global stakeholders weigh in on the urgent need to globally harmonize the guidelines toward the standardization of microphysiological systems. We discuss a possible framework for establishing scientific confidence and regulatory approval of these methods.
Topics & Concepts
StandardizationLegislatureBusinessRisk analysis (engineering)LegislationBiotechnologyBiologyPolitical scienceLaw3D Printing in Biomedical ResearchBiomedical Ethics and RegulationNeuroethics, Human Enhancement, Biomedical Innovations