Echazwe ngokufushane ngangokunokwenzeka, izithako ezisebenzayo zokwelapha ziyimakhemikhali emikhiqizweni yemithi eyenza imithi isebenze. Le ncazelo ayikho indawo eseduze nayo elula njengokuzwakalayo.
Ukuhlukanisa phakathi kwama-API kanye nezidakamizwa kwenza ukuthi abakhiqizi bakwazi ukwenza okukhethekile, abalawuli ukugxilisa izinsiza, kanye namakhemikhali ukuvumelanisa ukulinganisa okujwayelekile nemikhiqizo yegama lomkhiqizo.
Ukuqonda okwenza i-API ibe i-API, futhi kungani kufanele kube nokuqonda lokho, kuncike ekusebenzeni kanye nokulawulwa kwekhemisi.
Ama-API Ngokusho kwe-FDA ne-WHO
Ngokuqondile, ama-API angamakhemikhali asetshenziselwa imithi yansuku zonke kanye nemithi eminingi. Amaprotheni ayenziwe ngegazi kanye nama-molecule e-recombinant akha ama-biotech izidakamizwa awe ngaphansi kwezincazelo ezahlukene kanye nezinhlelo zokulawula.
I- US Yokudla Nezidakamizwa Zezidakamizwa ichaza ama-API njenge
Noma iyiphi into noma ingxube yezinto ezihloswe ukusetshenziselwa ekwakhiweni komkhiqizo wezidakamizwa nokuthi, uma isetshenziselwa ukukhiqizwa kwemithi, iba isithako esisebenzayo emkhiqizo wezidakamizwa. Izinto ezinjalo zihloswe ukuhlinzeka ngomsebenzi wezokwelapha noma enye impumelelo ngqo ekuxilongweni, ekwelapheni, ekunciphiseni, ekwelapheni noma ekuvimbeleni izifo noma ekuthintekeni isakhiwo nomsebenzi womzimba.
I- World Health Organization isungule incazelo efana ne-API efanayo.
Incazelo ye-WHO yayibuyekezwe kusukela ngo-September 2012, noma kunjalo. Iziphathimandla eziningi zomhlaba zikholelwa ukuthi ingxube ye-API empeleni yakha umkhiqizo oqediwe wemithi, okungaba umuthi wohlobo lwe-FDA olubhekisela "njengomkhiqizo wezidakamizwa."
Imikhiqizo yezokwelapha-okusho ukuthi, imithi yokwelapha imithi inikeze futhi iziguli zisebenzisa-zifaka eyodwa noma ngaphezulu API, izidakamizwa nezinye izithako ezivela kumadaka okuphuza utshwala namanzi.
Ubani owenza i-APIs?
Ama-API avame ukubhekwa ngokuthi "imithi eminingi," futhi amakhemikhali ngokuvamile atholakala ezitshalweni kude kakhulu ezindaweni lapho amaphilisi, ukumiswa ngomlomo kanye nezicelo zezingqungquthela zenziwa. Ekhiqizwe ngobuningi, cishe wonke ama-API ayi-powders.
Izitshalo zamakhemikhali kuwo wonke amazwe zenza imithi eminingi, kodwa abahlinzeki abahola phambili beqoqo lama-API eChina naseNdiya.
Kungakhathaliseki ukuthi i-API yenziwa kuphi, kufanele ihlangabezane namazinga okuphepha nekhwalithi asethwe ngumlawuli olawula izidakamizwa ezweni lapho lizosetshenziswa khona. Okusho ukuthi abakhiqizi bezidakamizwa abakwaShayina nabamaNdiya abathengisa amakhemikhali e-United States kumele bahlolwe futhi balayisenwe yi-FDA. Ngokufanayo, izidakamizwa eziningi ezikhiqizwa emazweni amaningi eYurophu zihambisana nezindinganiso ezisungulwe yi-European Medicines Agency.
Ukuhlola njalo futhi, uma kunesidingo, ukugwema abenzi bemikhiqizo ngaphandle kwezwe kungaba nzima. Ukuhlukunyezwa, ukuphinga, nokungcola kuhlala kuphazamiseka njalo ngama-API angeniswe e-United States nakwezinye izindawo. Kusukela ngo-2008, i-FDA iye yanda abasebenzi bayo base-overseas ababhekene nokuphathwa kwezimveliso eziningi zemithi.
Igama le-generic yi-API
Into yokugcina ukwazi nge-APIs yinto yokuqala, nge-twist.
Imithi yezinqwaba ngokwabo akuzona izidakamizwa ezivamile, kepha i-API ku-Lipfi's Lipitor kanye nesilinganiso ngasinye sokulingana kwayo i-atorvastatin. Njengoba kuphawuliwe ngenhla, ukwenza i-atorvastatin ibe umkhiqizo wezidakamizwa kudinga ukwengeza ezinye izithako ukwakha amaphilisi. Nokho, kubalulekile ukuthi abakwa-pharmacy nabachwepheshe bekhemisi bazi ukuthi yi-API yodokotela ngayinye ngoba igama le-API yigama elijwayelekile lemithi. Imihlangano emibili- Ama-United States Amagama Akhethiwe Namagama Angaphandle Okungabi Nabasebenzi -help ukuqinisekisa ukuthi i-API ngayinye ihlukile. Lapho i-FDA ivumela isidakamizwa esisha, i-ejensi idinga igama elijwayelekile lomkhiqizo ohlangabezana nezimfuneko ze-USAN / INN.
Lelo gama elijwayelekile lihlala nomkhiqizo wegama lomkhiqizo futhi liba igama lazo zonke imikhiqizo yezidakamizwa ezijwayelekile ezivunyelwe kamuva.
Igama lokubiza: ay-pee-eyez
Futhi eyaziwa njenge: APIs, imithi eminingi