Dab tsi yog generics: cov tshuaj pheej yig lossis cov khw muag tshuaj khib nyiab?

2024 Tus sau: Malcolm Clapton | [email protected]. Kawg hloov kho: 2023-12-17 03:58

Vim li cas generics thiaj li pheej yig thiab lawv tuaj yeem kho nrog lawv?

Dab tsi yog generics?

Generic (English generic, reproduced tshuaj) yog ib daim ntawv luam tshuaj uas coincides nrog tus thawj nyob rau hauv cov nqe lus ntawm tus nqi ntawm active tshuaj thiab cov nyhuv rau lub cev.

Thaum cov tshuaj tshiab tau tsim, nws tau tshawb fawb thiab sim rau lub sijhawm ntev, thiab tom qab ntawd muab patent. Thaum daim patent tas lawm, lwm lub tuam txhab kuj tuaj yeem tsim cov tshuaj zoo sib xws. Tab sis nyob rau hauv Russia, cov cai ntawm patent tuav yog feem ntau ua txhaum, thiab generics tau sau npe thiab muag txawm ua ntej patent rau thawj cov tshuaj tas sij hawm.

Cov generics puas muaj cov npe nyuaj?

Tsis tsim nyog. Txhua yam tshuaj muaj ob peb lub npe: tshuaj, lub npe thoob ntiaj teb uas tsis yog tswv cuab (INN), thiab lub npe lag luam.

Lub npe tshuaj yog ib kab lus uas tsis tau hais tawm uas tsis qhia koj dab tsi. INN yog lub npe tshwj xeeb rau cov tshuaj nquag uas tau pom zoo los ntawm WHO thiab yuav tsum tau qhia rau ntawm lub ntim ntawm cov tshuaj.

Tsis tas li ntawd, cov chaw tsim tshuaj muaj peev xwm muab lub npe lag luam rau nws cov khoom, uas yuav raug sau rau ntawm pob ntawv loj.

Piv txwv:

• Lub npe tshuaj: 2- (2- (2, 6-Dichlorophenylamino) phenyl) acetic acid (raws li sodium ntsev).
• INN: diclofenac.
• Lub npe lag luam: Voltaren, Vourdon, Diklak, Dikloberl, Olfen, Ortofen thiab ntau lwm tus.

Vim li cas tib neeg nyiam generics?

Vim lawv pheej yig dua. Ua ntej patenting cov tshuaj tshiab, cov tuam txhab siv nyiaj ntau ntawm nws txoj kev txhim kho thiab kev sim, thiab qhov no cuam tshuam rau tus nqi kawg. Cov txheej txheem sau npe rau generics yog yooj yim dua thiab sai dua. Qhov no piav qhia lawv qhov pheej yig.

Thiab tsis muaj kev tshawb fawb tau ua tiav?

Raws li txoj cai lij choj, rau kev sau npe ntawm cov tshuaj generic, es tsis txhob ntawm ib daim ntawv qhia ntawm ib tus kheej cov kev tshawb fawb preclinical, ib tug muaj peev xwm muab ib tug txheej txheem cej luam ntawm scientific cov ntaub ntawv ntawm cov kev tshwm sim ntawm preclinical kev tshawb fawb ntawm ib tug reproducible tshuaj, thiab es tsis txhob ntawm ib daim ntawv qhia ntawm ib tus kheej lub chaw kho mob. cov kev tshawb fawb, ib daim ntawv qhia txog qhov tshwm sim ntawm bioequivalence kev tshawb fawb ntawm ib tug reproduced tshuaj.

Bioequivalence qhia txog qhov twg thiab tus nqi ntawm kev nqus, lub sijhawm kom ncav cuag qhov siab tshaj plaws hauv cov ntshav, kev faib tawm hauv cov ntaub so ntswg thiab cov kua hauv lub cev, thiab tus nqi ntawm excretion.

Yog li kev tshawb fawb ua pov thawj qhov ua tau zoo thiab kev nyab xeeb ntawm cov tshuaj tshiab tseem tab tom ua, tab sis lawv tsis yog lub sijhawm ntev thiab kim npaum li cov tshuaj qub.

Thiab puas muaj ntau yam khoom siv hauv khw?

Raws li tsab ntawv ceeb toom ntawm lub tuam txhab tshuaj ntsuam xyuas DSM Group, hauv 2017 muaj 86.2% ntawm cov khoom lag luam hauv Lavxias. Thiab qhov no yog 0.5% ntau dua li xyoo 2016.

20.1% ntawm tag nrho cov muag generics yog cov tshuaj uas cuam tshuam rau lub plab zom mov thiab metabolism, 14.2% yog cov tshuaj rau kev kho mob ntawm cov kab mob ntawm lub paj hlwb, 14.0% yog tshuaj kho cov kab mob ntawm lub plawv system.

Yuav ua li cas txog lawv cov hauj lwm zoo?

Ib txoj kev tshawb fawb xyoo 2012 tau qhia tias tawm ntawm plaub yam khoom siv ntawm simvastatin (tshuaj rau txo cov roj cholesterol), tsuas yog ob qho tib si ua raws li cov thawj coj ntawm kev nyab xeeb thiab kev ua tau zoo.

Thiab nyob rau hauv 2013, nws tau muab tawm hais tias vim qhov txo cov hauj lwm zoo, generics yuav ua rau kom lub sij hawm ntawm kev kho mob los yog tsis muab ib yam dab tsi tshwm sim. Ntawm qhov tod tes, yog tias cov koob tshuaj tau nce ntxiv kom nrawm rau kev kho mob, cov teebmeem tsis zoo tuaj yeem tshwm sim.

Nws hloov tawm los ua ib qho kev rho npe tiag tiag: qee qhov generics tau zoo thiab muaj kev nyab xeeb raws li cov hauv paus, thaum lwm tus tuaj yeem ua kom ntev kev kho mob thiab ua rau muaj kev phiv.

Vim li cas cov generics yuav siv tau tsawg dua?

Kev ua tau zoo ntawm cov tshuaj yog cuam tshuam los ntawm ntau yam, suav nrog qib kev ua kom huv ntawm cov tshuaj nquag thiab cov khoom siv ntxiv uas yuav muaj cov generics. Yog tias ib lub tuam txhab yuav cov khoom muaj nqis pheej yig, cov tshuaj generic yuav tsis zoo txaus. Thiab cov khoom xyaw ntxiv tuaj yeem ua rau muaj kev fab tshuaj lossis kev phiv.

Yuav ua li cas kom paub qhov txawv ib tug zoo generic?

Ua ntej tshaj plaws, koj tuaj yeem tsom rau tus nqi. Yog hais tias cov tshuaj pheej yig heev, txawm tias piv rau lwm yam generics, cov chaw tsim tshuaj paus pom tseeb tau txais kev cawmdim ntawm ib yam dab tsi. Piv txwv li, ntawm qhov zoo ntawm cov khoom siv los yog ntawm kev tswj xyuas thaum lub sijhawm tsim khoom.

Qhov taw qhia zoo ntawm cov khoom zoo: kev tsim tshuaj muaj daim ntawv pov thawj GMP (Good Manufacturing Practice). Yog tias ib lub tuam txhab muaj daim ntawv pov thawj zoo li no, nws txhais tau hais tias nws cov khoom tsim tau raws li qhov yuav tsum tau ua (purity, kub, av noo), cov tshuaj ntau dhau tsis nkag mus rau hauv cov tshuaj, nws tau ntim kom zoo thiab khaws tag nrho nws cov khoom.

Koj yuav tsum siv generics?

Xav txog qhov sib koom ntawm generics ntawm kev ua lag luam Lavxias, peb tuaj yeem hais tias peb txhua tus tau raug kho nrog cov tshuaj zoo li no thiab tsis muaj dab tsi tsis ncaj ncees lawm. Generics ua kev kho mob pheej yig rau txhua tus ntawm ib qho nyiaj tau los thiab muab cov txiaj ntsig kho mob thiab kev nyab xeeb ntawm tus txheeb ze.

Thaum sau ntawv sau ntawv, tus kws kho mob qhia lub npe ntawm cov tshuaj nquag, yog li koj tuaj yeem xaiv nws tus kheej xaiv cov tshuaj tshwj xeeb lossis cov tshuaj qub (cov npe ntawm cov tshuaj qub thiab lawv cov generics tuaj yeem pom ntawm no). Feem ntau tus kws kho mob qhia ib qho pov thawj generic, qhov twg nws yog qhov zoo dua los siv nws. Yog tias cov tshuaj muab cov kev mob tshwm sim, koj yuav tsum tau sab laj nrog koj tus kws kho mob: tej zaum nws yuav sau cov tshuaj kim dua lossis cov tshuaj qub.