Lafiya da Bioequivalence

Kayan halitta da kwayar halitta sune dukkanin kalmomin da aka yi amfani dashi a cikin kantin magani don bayyana takamaiman ayyuka da kaddarorin kayan magani.

Bayanan halitta yana bayanin mutumin da ake gudanarwa na wannan yana cikin aiki a cikin jini bayan da aka yi amfani da miyagun ƙwayoyi a fili, a cikin intravenously ko wata hanya (eg, rectal, sublingual, nasal, transdermal, da dai sauransu)

Ta hanyar ma'anarta, magani ne da aka ba da shi cikin ɓoye yana da asali na 100% tun lokacin da aka kai shi tsaye cikin jini.

Akwai dalilai masu yawa waɗanda zasu iya rinjayar shayarwar likitanci. Sun hada da, a tsakanin sauran abubuwa:

Yin hulɗa tare da wasu magungunan ko abinci na iya shawo kan matsalar bioavailability. A cikin maganin HIV / AIDS , alal misali, magunguna na Norvir (ritonavir) - don inganta "maganin maganin miyagun ƙwayoyi na sauran kwayoyin cutar HIV- yana iya ƙara yawan kwayar halitta ta hanyar miyagun ƙwayoyi kamar Viagra (satinitafil citrate) . Ta yin haka, zai iya ƙara yawan rabi na Viagra yayin ƙarfafa abubuwan da ke ciki.

Hakanan, magungunan magnesium da magungunan aluminum (kamar Tums ko Milk na Magnesia) na iya rage yawancin kwayoyin cutar HIV a yayin da aka ɗauka lokaci daya - ta hanyar 74% tare da kwayoyi kamar Tivicay (dolutegravir) - kuma, a cikin yin haka, yana iya ƙetare manufofin farfadowa.

Halittar kwayar halitta shine lokacin da ake amfani dashi a cikin kantin magani don bayyana samfurori daban-daban na kwayoyin halitta wadanda, bisa ga ingancin su da aminci, sun kasance daidai.

Cibiyar Abinci da Drugura ta Amurka (FDA) ta bayyana yanayin rayuwa kamar "rashin bambanci da yawa a cikin nauyin da ake amfani da shi a cikin magungunan kamfanoni ko magungunan ƙwayoyi. Haka zalika a cikin irin wannan yanayi a cikin binciken da ya dace. "

Lafiya da kwayar halitta suna da alaka da juna kamar yadda dangantaka ta jiki (watau, kwatanta lissafiyar kwayar cutar daya zuwa wani) yana daya daga cikin matakan da ake amfani dasu wajen kimanta kwayar cutar kwayoyi.

Don amincewa da FDA, wata magungunan ƙwayar cuta dole ne ta nuna haɓaka kwalliya ta 90% (CI) a cikin duka har zuwa yawancin samfurori da aka kwatanta da na asali, magungunan magani.

> Sources:

> Muirhead, G .; Wuff, M .; Fielding, A ;; et al. "Abokin hulɗar Pharmacokinetic tsakanin sildenafil da saquinavir / ritonavir." Jaridar British Journal of Clinical Pharmacology. Agusta 2000; 50 (2): 99-107.

> Song, I .; Borland, J. Arya, N. et al. "Sakamakon masallatai da ƙarfe a kan pharmacokinetics na > dolutegravir > a cikin batutuwa masu kyau." Taron Duniya na 15 na Cibiyar Harkokin Kiwon Lafiyar HIV da Hepatitis Far; Washington, DC; Mayu 19-21, 2014; m P_13.

> Cibiyar Abinci da Druggun Amurka (FDA). "Jagora ga Masana'antu: Nazarin Halitta da Binciken Halitta na Halitta na Halittar Abinci - Binciken Farko." Silver Springs, Maryland.