505 (b) (2) hanyar sarrafawa
 505 (b) (2) hanyar sarrafawa |
|---|
Hanyar 505 (b) (2) tsari ne don gabatar da takamaiman sabon aikace-aikacen magani (NDA) tare da Hukumar Abinci da Magunguna a Amurka. An tsara shi ne don magunguna masu rikitarwa ko magunguna masu kula da halittu waɗanda zasu iya raba bayanan tarihi na jama'a daga magani wanda aka amince da shi a baya, saboda haka daidaita sake dubawa don amincewa da sauri.
Tsarin tsari
[gyara sashe | gyara masomin]Ikon shari'a ya samo asali ne daga 1984 lokacin da aka kara Dokar Gasar Farashin Magunguna da Dokar Maido da Takaddun shaida a cikin Dokar Magunguna da Kayan Kayan Kyakkyawan Gida ta 1938. [1]
An tsara 505 (b) (2) don samar da magunguna na yau da kullun waɗanda ke da maganin da aka jera (RLD). A cikin ambaton maganin da aka amince da shi a baya, sabon magani na iya ambaton bayanan jama'a kuma ya ci gaba ta hanyar rage gwajin.[2]
Ana buƙatar sabon magani na yau da kullun ya zama daidai da maganin asali a cikin tasirin warkewa da magunguna da abubuwan da ke tattare da kwayoyin halitta. Idan an nuna daidaito to kamfani zai gabatar da sabon magani ga FDA a cikin aikace-aikacen 505 (b) (2).[3]
Tsarin 505 (b) (2) yana daya daga cikin hanyoyi uku don amincewa da miyagun ƙwayoyi a Amurka; sauran sun haɗa da 505 (b) (1) da 505 "j) taƙaitaccen sabon aikace-aikacen miyagun ƙwalwa (ANDA).[2][4]
Canjin miyagun ƙwayoyi a cikin 505 (b) (2)
[gyara sashe | gyara masomin]Kamfanoni na iya samar da ɗaya daga cikin canje-canje da yawa a cikin magani don cancanta ga sake dubawa na 505 (b) (2), gami da adadin sashi daban-daban ko nau'in (kamar allura vs. baki), canji ga tsari ko sinadaran, ko sabon amfani na asibiti don wata alama ko cuta daban.[5]
Tasirin amincewar miyagun ƙwayoyi
[gyara sashe | gyara masomin]Kamfanonin miyagun ƙwayoyi na iya sa ran ƙananan kudade da amincewa da sauri ta amfani da aikace-aikacen 505 (b) (2), sakamakon samun dama ga bayanai daga maganin da aka ambata, ƙarancin ƙofar gwaji da kuma taƙaitaccen lokacin amincewa.[2]
Kungiyoyin sarrafawa, musamman FDA, dole ne su kula da hanyoyin sake dubawa masu aminci waɗanda ke isar da fa'idodin sabbin magunguna. Ana kunna wannan tare da tsarin 505 (b) (2) wanda ke amfani da aikace-aikacen magani da aka sake dubawa da amincewa don ƙirƙirar sabbin nau'ikan magunguna tare da hanyoyin magunguna masu tasowa kamar nanotechnology da gyare-gyare masu rikitarwa.[6]
Manazarta
[gyara sashe | gyara masomin]- ↑ Wood, Tyler (July 19, 2024). "Understanding the 505(b)(2) Pathway". Pharmacy Times. 13 (4).
- ↑ 2.0 2.1 2.2 Salminen, William F.; Wiles, Marc E.; Stevens, Ruth E. (2019-01-01). "Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway". Drug Discovery Today. 24 (1): 46–56. doi:10.1016/j.drudis.2018.07.005. ISSN 1359-6446. PMID 30041014. Cite error: Invalid
<ref>tag; name "Salminen-2019" defined multiple times with different content - ↑ Klein, Kevin (July 22, 2021). "A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways". Annals of the New York Academy of Sciences. 1502 (1): 5–13. Bibcode:2021NYASA1502....5K. doi:10.1111/nyas.14662. PMC 8597169 Check
|pmc=value (help). PMID 34296458 Check|pmid=value (help). - ↑ Research, Center for Drug Evaluation and (2024-08-09). "Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?". FDA (in Turanci).
- ↑ Salminen, William F.; Aloba, Olu; Drew, Angela; Marcinowicz, Agnieszka; Huang, Madelyn (2023-07-01). "US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development". Drug Discovery Today. 28 (7). doi:10.1016/j.drudis.2023.103618. ISSN 1359-6446. PMID 37196760 Check
|pmid=value (help). - ↑ Klein, Kevin (July 22, 2021). "A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways". Annals of the New York Academy of Sciences. 1502 (1): 5–13. Bibcode:2021NYASA1502....5K. doi:10.1111/nyas.14662. PMC 8597169 Check
|pmc=value (help). PMID 34296458 Check|pmid=value (help).