Ni irihe tandukaniro riri hagati ya Apis naba Farumasi?

Abahuza ba farumasi na APIs bombi bari murwego rwimiti myiza. Abahuza ni ibikoresho byakozwe mubikorwa byintambwe ya API bigomba guhinduka izindi molekuline cyangwa kunonosorwa kugirango bibe APIs. Abahuza barashobora gutandukana cyangwa ntibatandukanye. (Icyitonderwa: Aka gatabo karimo gusa abahuza isosiyete isobanura nkuko yakozwe nyuma yo gutangira umusaruro wa API.)

Ibikoresho bifatika bya farumasi (API): Ibintu byose cyangwa imvange yibintu bigenewe gukoreshwa mugukora ibiyobyabwenge kandi, iyo bikoreshejwe mugukora ibiyobyabwenge, bihinduka ikintu cyingenzi mubiyobyabwenge. Ibintu nkibi bifite ibikorwa bya farumasi cyangwa izindi ngaruka zitaziguye mugupima, kuvura, kugabanya ibimenyetso, gucunga cyangwa gukumira indwara, cyangwa bishobora guhindura imikorere nimiterere yumubiri. APIs nibicuruzwa bikora byarangije inzira ya synthesis, mugihe abahuza nibicuruzwa ahantu hamwe na synthesis. APIs irashobora gutegurwa muburyo butaziguye, mugihe abahuza bashobora gukoreshwa gusa muguhuza intambwe ikurikira yibicuruzwa. Gusa binyuze mu bahuza hashobora gukorwa APIs.

Birashobora kugaragara mubisobanuro ko abahuza aribicuruzwa byingenzi mubikorwa byimbere-yo gukora APIs kandi bifite imiterere itandukanye na API. Mubyongeyeho, hariho uburyo bwo gupima ibikoresho bibisi muri Pharmacopoeia, ariko ntabwo ari abahuza. Tuvuze ibyemezo, kuri ubu FDA isaba abahuza kwiyandikisha, ariko COS ntabwo. Ariko, dosiye ya CTD igomba kuba ifite ibisobanuro birambuye byerekana intera. Mubushinwa, nta GMP isabwa kubunzi.

Abahuza imiti ntibasaba impushya zo gukora nka APIs. Inzitizi zo kwinjira ni nkeya kandi irushanwa rirakaze. Kubwibyo, ubuziranenge, igipimo nubuyobozi akenshi nibyo shingiro ryo kubaho no guteza imbere imishinga. Umuvuduko ukabije wo kurengera ibidukikije watumye kandi amasosiyete mato menshi ava buhoro buhoro kuva mu marushanwa, kandi biteganijwe ko inganda ziyongera vuba.