Ukuchazwa ngokufutshane ngokungangoko kunokwenzeka, izithako ezichaphazelekayo eziyimveliso ziyimichiza kwimveliso yeziyobisi eyenza ukuba amayeza asebenze. Le nkcazo ayikho kufuphi elula njengoko ithetha.
Ukudweba phakathi kwama-API kunye neziyobisi kwenza ukuba abakhiqiza bakwazi ukuzimisela, abalawuli ukugxininisa izibonelelo, kunye nee- pharmist ukulungelelanisa ukulingana kwamayeza kunye nemveliso yegama lomenzi.
Ukuqonda oko kwenza i-API i-API, kwaye kutheni kubakho ukuqonda izinto, phantsi kokusebenza kunye nokulawulwa kwee-pharmacy.
APIs Ngokutsho kwe-FDA kunye ne-WHO
Ngokukodwa, ii-API ziimichiza ezisetyenziswe kwimiyalelo yansuku zonke kunye neyeza-counter-counter-medication. Iiprotheni ezivelisiweyo zezinto eziphilayo kunye nama-molecule avuselelayo adala izidakamizwa ze-biotech ziwela phantsi kweenkcazelo ezahlukeneyo kunye nezicwangciso zokulawula.
I- US Food Administration and Drug Administration ichaza i-APIs njenge
Naliphi na into okanye umxube wezinto ezijoliswe ukuba zisetyenziswe ekuvelweni kwemveliso yeziyobisi kwaye, xa zisetyenziselwa ukuveliswa kweziyobisi, ziba isithako esisebenzayo kwimveliso yeziyobisi. Izinto ezinjalo zijoliswe ekunikezeni umsebenzi wezolimo okanye enye impembelelo ngqo kwi-diagnostic, unyango, ukunciphisa, unyango okanye ukukhusela izifo okanye ukuchaphazela isakhiwo kunye nomsebenzi womzimba.
I- World Health Organization iye yavelisa inkcazo efana ne-API.
Inkcazo ye-WHO ihlaziywa ngo-Septemba 2012, nangona kunjalo. Amagunya amaninzi kumazwe angakholelwa ukuba umxube we-API ngokwenene ungumhlaba ogqityiweyo wezobisi, oya kuba ngumzimba wohlobo lwe-FDA lubhekisela "njengemveliso yeziyobisi."
Iimveliso zonyango-oko kukuthi, amayeza ogqirha abasabalalisa kunye nezigulane zisebenzisa-ziquka enye okanye ngaphezulu i-API, i-excipients kunye nezinye izithako ezivela kwiidayi zotywala kunye namanzi.
Ngubani owenza ii-APIs?
Ii-API zidla ngokuba zibizwa ngokuthi "izidakamizwa ezininzi," kwaye iikhemikhali zivame ukuba zenziwe kwizityalo ezikude zisuka kwiindawo apho izibhebhe, ukugxinwa ngomlomo kunye nezicelo zemibuzo yenziwa. Ekhutshwe ngobuninzi, phantse onke ama-API anama-powders.
Izityalo zeMichiza kuzo zonke iindawo zenza amayeza amaninzi, kodwa ngabaxhasi abahamba phambili beqela le-APIs eChina naseNdiya.
Kungakhathaliseki ukuba yenziwe phi i-API, kufuneka ihlangabezane nemigangatho yokhuseleko kunye nemigangatho ebekwe ngumlawuli olawula iziyobisi kwilizwe apho iya kusetyenziswa khona. Okokuthi, abavelisi bezonyango baseTshayina nabaseIndiya abazithengisa iikhemikhali eUnited States kufuneka bahlolwe kwaye banikwe ilayisenisi yi-FDA. Ngokufanayo, amayeza amaninzi akhiqizwa kumazwe amaninzi eYurophu ayaxhomekeke kumgangatho osungulwe yi-Arhente yeeMithi zeYurophu.
Ukuhlolisisa rhoqo kwaye, xa kuyimfuneko, ukucwangcisa abenzi beekhemikhali ngaphandle kwelizwe kunokubanzima. Ukuchasana, ukuphanga kunye nokuhlambuluka kukuhlala kuxhalabisayo ngama-API angeniswe kwi-United States nakwezinye iindawo. Ukususela ngo-2008, i-FDA iye yandise abasebenzi bayo base-overseas abajongene nokujongana nabavelisi bamachiza abaninzi.
Igama loGeneric yi-API
Into yokugqibela ukwazi nge-APIs yinto yokuqala, nge-twist.
Izidakamizwa ezininzi ngokwazo azikho iziyobisi eziqhelekileyo, kodwa i-API kwi-Lipid's Lipitor kwaye nganye yemilinganiselo yayo yesiqhelo i-atorvastatin. Njengoko kuphawuliwe ngasentla, ukwenza i-atorvastatin kwimveliso yeziyobisi kufuna ukongeza ezinye izithako ukwenza iipilisi. Kubaluleke kakhulu, nangona kunjalo, ukuba oomoshemisti kunye neengcali zezolimo ziyazi ukuba ngubani na i-API yonyango ngalinye ngenxa yokuba igama le-API ligama eliqhelekileyo lonyango. Iindibano ezimbini-e-United States Amagama Awamkelwayo kunye namagama angaphandle angabandakanyeki -help ukuqinisekisa ukuba nganye i-API inobumba obuhlukile. Xa i-FDA ivuma isiza esitsha, i-arhente idinga igama eliqhelekileyo kwimveliso ehlangabezana neemfuno ze-USAN / INN.
Lelo gama eliqhelekileyo lihlala kunye nomkhiqizo wegama lomenzi kwaye liba negama lazo zonke iimveliso zonyango ezifanayo ezivunyiweyo.
Ukubiza igama: ay-pee-eyez
Eyaziwa ngokuba njenge: APIs, amayeza amaninzi