Early Hum.Dev
They asked two questions I can not answer: 1)Should they Perform their irritation assay using in vitro methods outlined in ISO 10993-23 or stick with the old rabbit intracutaneous
Key sources included the US Food & Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) Japan, Medicines and Healthcare products Regulatory Agency (MHRA) UK, National Institutes of Health (NIH), National Center for Biotechnology Information (NCBI/PubMed), Centers for Disease Control and Prevention (CDC) National Diabetes Statistics Report, World Health Organization (WHO) Global Health Observatory, International Diabetes Federation (IDF) Diabetes Atlas, American Diabetes Association (ADA) Standards of Care, European Association for the Study of Diabetes (EASD) Guidelines, IQVIA Institute for Human Data Science, Evaluate Pharma, and national health ministry reports from key markets (China NMPA, India CDSCO, Brazil ANVISA)
Data availability Data is provided within the manuscript files
There is also a metabolic argument worth making