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] |
---|
Links: |
---|
Themen: |
Alternative testing |
---|
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 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | NLM360870562 | ||
003 | DE-627 | ||
005 | 20231227133646.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231226s2023 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1002/ddr.22108 |2 doi | |
028 | 5 | 2 | |a pubmed24n1231.xml |
035 | |a (DE-627)NLM360870562 | ||
035 | |a (NLM)37587871 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Akash, Sajidur Rahman |e verfasserin |4 aut | |
245 | 1 | 0 | |a FDA Modernization Act 2.0 |b An insight from nondeveloping country |
264 | 1 | |c 2023 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 18.12.2023 | ||
500 | |a Date Revised 18.12.2023 | ||
500 | |a published: Print-Electronic | ||
500 | |a Citation Status MEDLINE | ||
520 | |a © 2023 Wiley Periodicals LLC. | ||
520 | |a 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 | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a FDA | |
650 | 4 | |a alternative testing | |
650 | 4 | |a animal testing | |
650 | 4 | |a clinical trial | |
650 | 4 | |a nondeveloping country | |
650 | 7 | |a Pharmaceutical Preparations |2 NLM | |
700 | 1 | |a Arnob, M A Jobayer Billah |e verfasserin |4 aut | |
700 | 1 | |a Uddin, Md Jamal |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Drug development research |d 1993 |g 84(2023), 8 vom: 17. Dez., Seite 1572-1577 |w (DE-627)NLM081794991 |x 1098-2299 |7 nnns |
773 | 1 | 8 | |g volume:84 |g year:2023 |g number:8 |g day:17 |g month:12 |g pages:1572-1577 |
856 | 4 | 0 | |u http://dx.doi.org/10.1002/ddr.22108 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 84 |j 2023 |e 8 |b 17 |c 12 |h 1572-1577 |