| Autor: |
BUKHARI, ZARA, GIBRAIEL, FAROGH, SHETH, SMRITIE, BAKHALE, CHAITRALI, CHIRMULE, NARENDRA |
| Předmět: |
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| Zdroj: |
BioPharm International; Jul/Aug2024, Vol. 37 Issue 7, p28-28, 1p |
| Abstrakt: |
Biosimilars have transformed access and cost of healthcare globally. There has been an explosion of technological advances in biotechnology and computational systems in the past decade. Regulations have also evolved to meet technological advances; for example, exploring real-world evidence to inform regulatory decisions is mandated by the 21st Century Cures Act. The authors have reviewed applications of these novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements. The advances in process development include process analytical technology and multivariate analysis methods for real-time monitoring and analysis of critical quality attributes and continuous manufacturing processes, which can reduce the manufacturing footprint and increase efficiencies. The applications of artificial intelligence/machine learning in pharmacology, toxicology, and clinical trials have been reviewed. These processes have accelerated development time and decreased cost of biosimilars development. Regulatory considerations on quality aspects of biosimilars are listed as well as some of the major challenges in biosimilars development. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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