Pofotokozedwa mwachidule ngati n'kotheka, mankhwala omwe amagwira ntchito ndi mankhwala omwe amapanga mankhwala. Tsatanetsataneyo ilibe pafupi ndi zosavuta kumva.
Kujambula kusiyana pakati pa API ndi mankhwala kumapangitsa kuti opanga apange makina, olamulira kuti aganizire zofunikira, komanso asamalimoto kuti agwirizane zofanana ndi zolembapo.
Kumvetsetsa zomwe zimapangitsa API kukhala API, ndipo chifukwa chiyani kukhala ndi nkhani zomvetsetsa, kumagwiritsanso ntchito ndi malamulo a mankhwala.
APIs Malingana ndi FDA ndi WHO
Makamaka, API ndi mankhwala ogwiritsidwa ntchito tsiku ndi tsiku mankhwala ndi mankhwala owonjezera. Mapuloteni komanso mapuloteni opangidwa ndi zinthu zamoyo zomwe zimapangidwira mankhwala osokoneza bongo amagwa pansi pa matanthauzo osiyanasiyana ndi ndondomeko zoyenera.
Bungwe la US Food and Drug Administration limafotokoza API monga
Chinthu chirichonse kapena kusakaniza kwa zinthu zomwe zingagwiritsidwe ntchito popanga mankhwala osokoneza bongo komanso kuti, pogwiritsidwa ntchito popanga mankhwala, zimakhala mankhwala othandizira mankhwala. Zinthu zoterezi zimapangidwira ntchito zamagetsi kapena zotsatira zina mwachindunji pa matenda, matenda, kuchepa, mankhwala kapena kupewa matenda kapena kukhudza kapangidwe ka thupi.
Bungwe la World Health Organization lapanga ndondomeko yofanana ya API.
Tsatanetsatane wa WHO inali yowerengedwa pofika mu September 2012, komabe. Akuluakulu a mayiko ambiri amakhulupirira kuti pulogalamu ya APIs kwenikweni imakhala mankhwala omwe anamaliza, omwe angakhale mankhwala a mtundu wa FDA womwe umatcha "mankhwala opangidwa ndi mankhwala."
Zamagwiritsidwe ntchito mankhwala osokoneza bongo-zomwe zikutanthauza kuti madokotala amapereka mankhwala ndipo odwala amagwiritsira ntchito-kuphatikizapo imodzi kapena yochuluka API, zopangira zinthu zina ndi zowonjezera zina kuchokera ku utoto wa mowa ndi madzi.
Ndani Amapanga APIs?
Ma API amatchulidwa kuti "mankhwala ambiri," ndipo mankhwala amatha kupangidwa kutali kwambiri ndi malo omwe mapiritsi, mapulotedwe amlomo, ndi mapulogalamu apamwamba amapangidwa. Zapangidwa mochuluka, pafupifupi API yonse ndi ufa.
Mitengo ya mankhwala m'mayiko onse imapanga mankhwala ochuluka, koma akutsogolera ogulitsa APIs ku China ndi India.
Mosasamala kanthu komwe API imapangidwira, iyenera kukwaniritsa miyezo ya chitetezo ndi zapamwamba zomwe zimatsogoleredwa ndi wotsogolera mankhwala otsogolera m'dziko lomwe lidzagwiritsidwe ntchito. Izi ndizo, omwe amapanga mankhwala osokoneza bongo achi China ndi Indian omwe amagulitsa kunja ku United States ayenera kuyang'aniridwa ndikupatsidwa chilolezo ndi FDA. Momwemonso, mankhwala ambirimbiri opangidwa m'mayiko ambiri ku Ulaya akutsatira mfundo zomwe bungwe la European Medicines Agency linakhazikitsa.
Kuyang'anitsitsa nthawi zonse, ndipo pakufunika, kukonza mankhwala opanga mankhwala kunja kwa dziko kungakhale kovuta. Kugonana, chigololo, ndi kuipitsidwa zimakhalabe zovuta nthawi zonse ndi ma API otumizidwa ku United States ndi kwina kulikonse. Kuyambira m'chaka cha 2008, a FDA akhala akutambasula ogwira ntchito kunja kwa dziko kuti aziyang'anira olemba mankhwala ambiri.
Dzina la Generic Ndi API
Chinthu chotsiriza kudziwa za APIs ndichinthu choyamba, ndi kupotoza.
Mankhwala amadzimadzi okha sali mankhwala ochiritsira, koma API ya Pfizer's Lipitor ndi iliyonse yowonjezera yowonjezera yake ndi atorvastatin. Monga taonera pamwambapa, kupanga atorvastatin kukhala mankhwala opanga mankhwala kumafuna kuwonjezera zina zopangira kupanga mapiritsi. Ndizofunikira kwambiri, komabe, asayansi ndi akatswiri a zamankhwala amadziwa kuti API iliyonse ya mankhwala ndi yani chifukwa dzina la API ndi dzina lachibadwa la mankhwala. Misonkhano iwiri - United States Yopatsidwa Maina ndi Mayina Osavomerezeka Azinenero Zonse -chicheperetsa kuti API iliyonse imadziwika bwino. Pamene FDA ikuvomereza mankhwala atsopano, bungwe likufuna dzina lachibadwa la mankhwala omwe amakumana ndi zoyenera za USAN / INN.
Dzina lachibadwali limakhala ndi mankhwala a dzina lake ndipo limakhala dzina la mankhwala onse oyenera omwe amagwiritsidwa ntchito povomerezeka.
Kutchulidwa: ay-pee-eyez
Komanso: API, mankhwala ambiri