Ukuhlaziywa kwamanzi kunye nohlobo lwee-bioequivalence zombini amagama asetyenziswa kwi-pharmacology ukuchaza izenzo ezithile kunye neepropati zemveliso yeziyobisi.
Ukuhlaziywa kwemvelo kuchaza umntu we-dose elawulwayo leyo ehamba ngokusasazekayo kwigazi xa nje isilwanyana sithunyelwa ngomlomo, nge-intravenously okanye nayiphi na enye indlela (umz., I-rectal, isiqendu, i-nasal, i-transdermal, njl.
Ngenkcazo, iziyobisi ezithunyelwa nge-intravenously ine-bioa availability of 100% ekubeni ihanjiswa ngqo kwigazi.
Kukho inani lezinto ezinokuchaphazela ukufumaneka kwezidakamizwa. Ziquka phakathi kwezinye izinto:
- Iipropati zemvelo zesilwayo, kubandakanywa nezilwanyana zobomi
- Ukuqulunqwa kweziyobisi (umzekelo, ukukhululwa ngokukhawuleza, ukukhululwa kwexesha)
- Impilo yesisu yomguli
- Ubudala besigulane, esinokuchaphazela isantya se-metabolism
- Ingaba isicatshulwa sithathwa kunye okanye ngaphandle kokutya
- I-Renal (intso) kunye nomsebenzi we-hepatic (isibindi), ochaphazela izibonelelo zemvume
Ukusebenzisana namanye amachiza okanye ukutya kunokuphazamisa ngqo ukungafumaneki. Ngokonyango lwe-HIV / AIDS , umzekelo, i- antivirroviral isilwanyana i- Norvir (ritonavir) esetyenziswe "ukukhulisa" ukuxilongwa kweziyobisi ze-serum kwezinye iidakamizwa ze-HIV- kunokunyusa ukwanda kokusetyenziswa kwezilwanyana njenge- Viagra (sildenafil citrate) . Ngokwenza njalo, kunokwandisa kakhulu isigxina-ubomi se-Viagra ngelixa iphakamisa iziphumo ezibi.
Ngakolunye uhlangothi, i-anti-magnesium kunye ne-aluminium-based antiacids (njenge-Tums okanye iMil of Magnesia) inokunciphisa kakhulu ukungafumaneki kwezidakamizwa ezininzi ze-HIV xa zithathwa kanyekanye - zingama-74% ngezilwanyana ezifana neTivicay (dolutegravir) ekwenzeni oko, kunokungonakalisa iinjongo zonyango.
I-Bioequivalence iyigama elisetyenziswe kwi-pharmacology ukuchaza ezimbini iimveliso zeziyobisi ezahlukileyo, ezisekelwe ekusebenzeni kwabo kunye nokukhuseleko, zifana ngokufanayo.
I-US Food Management and Drug Administration (i-FDA) ichaza i-bioequivalence ngokuthi "ukungabikho kwempembelelo ephawulekayo kwinqanaba kunye nomlinganiselo apho isisombululo esisebenzayo okanye inxaxheba esebenzayo kwimilinganiselo yezobisi okanye amayeza athile ayafumaneka kwisiza sezenzo zamachiza xa kulawulwa i-molar dose efanayo phantsi kweemeko ezifanayo kwisifundo esifanelekileyo.
Ukuhlaziywa kwamanzi kunye ne-bioequivalence zihambelana ngokuthe ngqo kunye nokuxhamla (i-bioavailability of one drug to another) ngenye yeendlela ezisetyenziselwa ukuvavanya i-bioequivalency yezilwanyana.
Ukuvunyelwa kwe-FDA, isiza esinokuthi sibonise i-90% yexesha lokuzithemba (CI) kwinqanaba kunye nokulinganiselwa kokungabikho kokuthelekiswa nokuthelekiswa nokuthelekiswa kwezilwanyana.
> Imithombo:
> Muirhead, G; Wuff, M .; Fielding, A .; okqhubekayo. "Intsebenziswano ye-Pharmacokinetic phakathi kwe-sildenafil kunye ne-saquinavir / ritonavir." IBritish Journal ye-Clinical Pharmacology. Agasti 2000; 50 (2): 99-107.
> Ingoma, mna .; Borland, J .; Arya, N; okqhubekayo. "Impembelelo ye-calcium kunye ne-iron supplements kwi-pharmacokinetics ye- dolutegravir > kwizifundo ezinempilo." I-International Workshop ye-15 kwi-Clinical Pharmacology ye-HIV kunye ne-Hepatitis Therapy; EWashington, DC; NgoMeyi 19-21, 2014; P_13.
> Ulawulo lweZiko lokuTya kunye neDrug (FDA). "Isikhokelo Soshishino: Ukufumaneka kwezinto kunye nokuFundiswa kweeBoeququence for Products Ordered Ordinance - Iingqwalasela ngokubanzi." Silver Springs, Maryland.