Zvichitsanangurwa zvishomanana sezvinobvira, kushandiswa kwemishonga inoshandiswa mishonga ndiyo makemikari mumishonga yemishonga inoita kuti mishonga inoshanda. Tsanangudzo iyo haina nzvimbo iri pedyo neyo nyore sezvinonzwika.
Kugadzira kusiyana pakati peApps nemishonga inoita kuti zvive nyore kune vanogadzirisa kuisa mazano, vatongi kuti vaongorore zvishandiso, uye vanachiremba kuti vaenzanise maitiro akafanana nemikirini yezita rechigadzirwa.
Kunzwisisa chinokonzera API ne API, uye nei uchive nenhau dzinonzwisisika, pasi pekushanda nekugadzirisa kwemafirosi.
APIs Maererano neCDA uye WHO
Kunyanya, APIs makemikari anoshandiswa muzvinyorwa zvezuva nezuva uye mishonga inopfuura-in-counter. Biologically engineered proteins uye mamoleksi akadzoka akaumbwa nemishonga inoshandiswa kwezvinhu zvinoshandiswa purogiramu inowira pasi pemitsananguro yakasiyana uye kuronga zvirongwa.
IU.S. Food and Drug Administration inotsanangura ma APIs se
Chero chinhu chipi nechipi kana kusanganiswa kwezvinhu zvakagadzirirwa kushandiswa pakugadzirwa kwechigadzirwa chemishonga uye kuti, kana chichishandiswa mukugadzirwa kwemishonga, inoshandiswa pakugadzirwa kwechirongwa chemishonga. Zvinhu zvakadai zvinotarisirwa kuita mabasa ezvemishonga kana zvimwe zvinogadziriswa muhutano, kurapwa, kuderedza, kurapa kana kudzivirira zvirwere kana kukanganisa maitiro uye basa remuviri.
World Health Organization yakagadzira tsanangudzo yakafanana neyo API.
Tsanangudzo yeWHO yaiva pasi pekuongororwa saSeptember 2012, zvisinei. Mahofisi mazhinji enyika dzakawanda anotenda kuti musanganiswa weAAPI chaizvoizvo unoumba mushonga wemishonga wakagadzirwa, uyo waizova mushonga wechiratidzo iyo FDA inoreva se "chigadzirwa chemishonga."
Zvinodhaka-zvinoreva kuti, mishonga yemishonga inoparadzira uye varwere vanoshandisa-inosanganisira imwe kana kupfuura API, zvinokonzerwa nezvimwe zvinoshandiswa kubva kubva kumadhora kune doro nemvura.
Ndiani Anoita APIs?
APIs inowanzotumidzwa se "mishonga yakawanda," uye makemikari kazhinji anowanikwa mumiti yakasununguka kubva kune zvivako umo mahwendefa, kusungirirwa mumuromo, uye zvinyorwa zvemashoko zviri kuitwa. Yakabudiswa nehuwandu, inenge yose APIs iri pfupfu.
Makemikari mumiti yose inogadzira mishonga yakawanda, asi vanotengesa mapoka emaposi eAPIs muChina nekuIndia.
Pasinei nokuti apo API inogadzirwa sei, inofanirwa kusangana nekuchengeteka uye hutano hwakanaka hunotungamirirwa nevatungamiri vezvinodhaka mutemo munyika iyo ichashandiswa. Ndiko kuti, vatori vechiChinese uye vaIndia vanodhaka zvinodhaka zvinotengeserana nemakemikari kuUnited States vanofanira kuongororwa uye vane mvumo neCDA. Saizvozvowo, mishonga yakawanda inoberekerwa kunyika dzakawanda muEurope inowirirana nemitemo yakagadzwa neEuropean Medicines Agency.
Kuongorora nguva dzose uye, kana zvichidiwa, kururamisa makemikari kunze kwenyika kunogona kuoma. Kurwisana, upombwe, nekusvibiswa zvinoramba zvichinetseka neAAPIs inotengeswa kuUnited States uye kune imwe nzvimbo. Kubvira muna 2008, FDA yave iri kuwedzera vashandi vayo vekumavirira kune imwe nyika iyo inotarisirwa kutarisira mashizha makuru emishonga.
Izwi rechi generic Ndiyo API
Chinhu chekupedzisira kuziva nezve APIs chaiva chinhu chekutanga, nechinokanganisa.
Mishonga yemabhakhi pachavo haisi yemishonga yemishonga, asi API muPfizer's Lipitor uye chimwe nechimwe chezvienzanidzo zvayo ndeye atorvastatin. Sezvakataurwa pamusoro apa, kugadzira atorvastatin muchigadzirwa chemishonga kunoda kuwedzera zvimwe zvigadzirwa kuti zvive mahwendefa. Zvinonyanya kukosha, zvisinei, kuti vanachiremba uye vadzidzisi vezvemishonga vanoziva huzivikanwa hwePAI yega yega yega nokuti zita rePAI ndiro zita rinoshandiswa remishonga. Kokorodzano mbiri- United States Mazita Akakodzwa uye Mazita Asingawanikwi Munyika Yose -help anovimbisa kuti API imwe neimwe inonyanya kuzivikanwa. Apo FDA inobvumira mushonga mutsva, sangano rinoda zita rechiito chechigadzirwa chinosangana neUnited USAN / INN.
Zita iro rinowanzogara nezita rechigadzirwa chezita uye rinova zita rezvose zvinokonzera zvinodhaka zvinodhaka izvo zvakagamuchirwa.
Kutumidzwa: ay-pee-eyez
Uyewo Anozivikanwa Se: APIs, mishonga yakawanda