Apo Rinouya Kumishonga, Iwe Unowana "Zvaunobhadhara" Here?
Ndiyo mubvunzo wakaoma kwazvo wawakasangana nawo muchitoro kubva panguva yekutanga iwe wakabvunzwa "pepa kana plastiki?" Iwe uri paremisi inoshandisa mishonga yako uye muzvinamorija anotendeukira kwauri kuti akubvunze, "Ndiyo maitiro chaiwo OK?" Iwe unononoka kuongorora zvaunogona kuita: zvinodhaka zvinodhura zvinodhura zvishomanana, asi zvino zvakanyatsofanana here nezita rezita rezita ?
Unofanira kuwana ruzivo uye kuchengetedza zvishoma here?
Mhinduro yacho inofadza "zvichida." Mune zviitiko zvakawanda, zvinodhaka zvinowanzoonekwa zvakachengeteka nemhaka yenzira yekuedza inoshandiswa neDain and Drug Administration (FDA).
Patent Pamishonga Inodhaka
Makambani emishonga anoisa mari yakawanda yemari pakugadzira mishonga yavo. Kuti uwanezve mari iyo, iyo inogona kuva mumazana emamirioni emadhora, hurumende yeUnited States inopa pepa kana kuti oga pane zvinodhaka.
Ipa patent inotsanangurwa se "kodzero yekuregedza vamwe kubva pakugadzira, kushandisa, kupa, kutengesa, kana kutengesa." Mune mamwe mazwi, hapana imwe kambani yezvinodhaka inogona kugadzira mishonga imwechete mune ma laboratori uye ichiitengesa. Patent inogona kuramba kwenguva yakareba semakore makumi maviri, asi rimwe rega rega patent rakasiyana. Chirongwa chekodzero chinogona kubudiswa chero nguva panguva yemvumo yekugadzirwa kwemishonga. Nokudaro, chirwere chinogona kunge chiri chepentamende, asi chisati chabvumidzwa neRDA kuti ishandiswe kune varwere.
Kunyanya kushandisa zvinodhaka
Izvozvakodzero yakafanana inonzi kodzero inogonawo kupiwa kambani yemishonga yemishonga yavo itsva. Kuburitsa kunotsanangurwa se "kodzero dzekutengeserana dzakapiwa neCDA pane kugamuchirwa kwechirwere." Yakagadzirirwa kuuraya kuenzanisa pakati pekugadzirwa kwemishonga mitsva uye kutengeserana kwevanhu, izvo zvingangodaro kana kuti zvingasaenderana ne patent.
Kureba kwehumwe chete kunobva kune rudzi rwechirwere icho chiri kupiwa, uye runogona kuva chero kubva kune makore matatu kusvika kune manomwe. Apo kodzero yepamutemo uye yega inopera, mamwe makambani emishonga anogona kugadzirisa zvakare chirwere uye ozvitengesa ivo pachavo pasi pezita rakasiyana. Izvi zvinozarura misika yemakwikwi uye inotora mari yezvigadzirwa zvepasi.
Chirwere Chirwere uye Bioequivalency
Chirwere chemishonga inofanira kuva nemishonga yakadaro inoshandiswa sezita rechiratidzo, asi zvigadzirwa zvisina basa zvinogona kunge zvakasiyana. Zvishandiso zvisina kushandiswa zvinogona kusanganisira mavara, zvigadziri, kana zvimwe zvizere. Zvisinei, nemhaka yokuti generic ine zvimwe zvinokanganisa zvinoshandiswa hazvirevi kungofungidzirwa sechinhu chakafanana.
Imwe kambani yemishonga inoshuva kutengesa mishonga yavo yakakwana inofanira kupa uchapupu hwe bioequivalency kune FDA. Kuti zvive bioquivalent, zvinoshandiswa zvinoshandiswa muzvinodhaka zvinokonzerwa nemutambo zvinofanirwa kuwedzerwa pamutengo wakafanana uye nechiyero chakafanana sezita rechiratidzo chemishonga. Izvo zvinotarisirwa hazvifanirwi kuita zvakafanana nezita rechiratidzo chemishonga, asi inofanira kuwira mukati mimwe mirayiridzo yakagadzirirwa neCDA. Aya mazano anogona kusiyana kubva pamishonga kusvika kune zvinodhaka.
Kuti uve nechokwadi chokuti chirwere chinowanzopiwa iwe chave chakagadzirwa se bioequivalent kune zita racho, chengeta nemumwe wako wemishonga.
Mutori wemapurisa wako anokwanisa kuwana ruzivo pamusoro pemishonga inowanzobva kuDaily's Orange Book. Bhuku reArisand rine mazita ezvinodhaka uye maitiro avo e-bioequivalency. Iko shanduro yemagetsi inotsvakurudzwa nemishonga inoshandiswa uye inoshandisa (zita) zita.
Nzira uye Nenguva Yokusarudza Generic
Kana chiremba wako akanyora chiremba chechirwere chinoshandisa zita rechirwere ichocho, mutori wemasitori anofanira kuzvizadza nemutsetse uyu. Mufaramidzi anogona kushevedza chiremba wako uye kutaura pamusoro pekuisa chinzvimbo chechimiro chechirwere. Kana, iwe unogona kutaura nachiremba wako pamusoro pezvakawanda kana zvinodhiwa mishonga kana chirongwa ichi chakanyorwa.
Kana iwe ukashamiswa nekambani yemishonga nemubvunzo pamusoro pezita rechirwere kana kuti maitiro, tumira mahofisi echiremba wako. Chiremba uyo akarayira mishonga kwauri iwe achaziva kana iwe unogona kuwana mhinduro inoda neicho.
Sources:
US Food and Drug Administration. "Chii Chinokonzera Zvinodhaka?" FDA.gov 16 Gunyana 2008.
US Food and Drug Administration. "Mibvunzo Inowanzobvunzwa Pamusoro pePentent uye Kubva." FDA.gov 28 Apr 2006.