FDA Modernization Act 2.0 : An insight from nondeveloping country

© 2023 Wiley Periodicals LLC..

Animal testing is required in drug development research and is crucial for assessing the efficacy and safety of medications before they are commercialized. However, the newly furnished Food and Drug Administration Modernization Act 2.0 has given new insight into drug development. It opens a new door by offering an alternative testing method for developing a new drug without using animals. This newly proposed system may potentially significantly impact nondeveloped countries worldwide. In this study, we explore the alternative testing options such as in silico modeling, human tissue-on-chip engineering, animal-free recombinant antibodies, tissue engineering, and artificial intelligence presented by this act and discuss its implications for nondeveloped countries.

Medienart:

E-Artikel

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

Zur Gesamtaufnahme - volume:84

Enthalten in:

Drug development research - 84(2023), 8 vom: 17. Dez., Seite 1572-1577

Sprache:

Englisch

Beteiligte Personen:

Akash, Sajidur Rahman [VerfasserIn]
Arnob, M A Jobayer Billah [VerfasserIn]
Uddin, Md Jamal [VerfasserIn]

Links:

Volltext

Themen:

Alternative testing
Animal testing
Clinical trial
FDA
Journal Article
Nondeveloping country
Pharmaceutical Preparations

Anmerkungen:

Date Completed 18.12.2023

Date Revised 18.12.2023

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1002/ddr.22108

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM360870562