Scientific Articles

2024/10/31

Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective

Artificial Intelligence (AI) has the disruptive potential to transform patients’ lives via innovations in pharmaceutical sciences, drug development, clinical trials, and manufacturing. However, it presents significant challenges, ethical concerns, and risks across sectors and societies.
2024/10/28

A timely recommendation to the european medicines agency and the FDA on rationalizing comparative clinical efficacy testing of biosimilars

Biosimilars, copies of biological therapeutic proteins, for which regulatory guidelines were established 19 years ago in the EU and 15 years ago in the US, based on the understanding that comparative testing with reference products should reduce the time and cost burden for their approval, enabling their accessibility, availability, and affordability.
2024/10/24

MicroRNA Nobel Prize: A Timely Recognition, and a High Anticipation—A Detailed Analysis to Assist

microRNAS (miRNAs) maintain cellular homeostasis by blocking mRNAs through binding with t-RNA to fine-tune the expression of genes across numerous biological pathways. The 2024 Nobel Prize in Medicine and Physiology for the discovery of miRNA was long overdue and now we anticipate a deluge of research work involving miRNA to repeat the history with other RNA prizes.
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