Li-bioavailability le li-bioequivalence li sebelisoa ka bobeli ho pharmacology ho hlalosa liketso le likarolo tse itseng tsa sehlahisoa sa lithethefatsi.
Li-bioavailability li hlalosa motho ea nang le tekanyo e laolang ea eona e sebetsang ka potlako ka mali hang ha moriana o fanoa ka molomo, ka litsela tse ling kapa ka litsela tse ling (mohlala, mahlakore a mabeli, a mangolo a mangata, a macha, a transdermal, joalo-joalo)
Ka tlhaloso, lithethefatsi tse fanoang ka ntle ho tsona li na le bothata ba li-100% kaha li fanoa ka ho toba maling.
Ho na le lintlha tse 'maloa tse ka susumetsang ts'oaetso ea lithethefatsi. Li akarelletsa, har'a lintho tse ling:
- Matlalo a lithethefatsi, ho kopanyelletsa le lithethefatsi tsa halofo ea bophelo
- Tlhahiso ea lithethefatsi (mohlala, ho lokolloa kapele, ho lokolloa ha nako)
- Bophelo bo botle ba meriana ea mokuli
- Nako ea mokuli, e ka amang lebelo la metabolism ea lithethefatsi
- Ho sa tsotellehe hore na meriana e nkiloe kapa e se na lijo
- Li-ralal (liphio) le mosebetsi oa hepatic (sebete), o fellang ka tumello ea lithethefatsi
Ho sebelisana le lithethefatsi tse ling kapa lijo le hona ho ka kena-kenana ka kotloloho le tlhahiso ea bioa. Ka mohlala, kalafo ea HIV / AIDS , setlhare sa antiretroviral Norvir (ritonavir) se sebeliselitsoeng ho "matlafatsa" mehopolo ea lithethefatsi ea serum ea lithethefatsi tse ling tsa HIV-le tsona li ka eketsa mokhoa oa ho sebelisoa ha lithethefatsi joaloka Viagra (sildenafil citrate) . Ha o etsa joalo, o ka eketsa halofo ea bophelo ba Viagra ha a ntse a phahamisa litla-morao.
Ka lehlakoreng le leng, li-antacids tse nang le li-anti-magnesium le li-aluminium (tse kang Tums kapa Milk ea Magnesia) li ka fokotsa haholo tlhahlobo ea likokoana-hloko tse ngata tsa HIV ha li nkoa ka nako e le 'ngoe - ho fihlela ho 74% ka lithethefatsi tse kang Tivicay (dolutegravir) ka ho etsa joalo, ho ka 'na ha fokotsa lipakane tsa phekolo.
Li-bioequivalence ke lentsoe le sebelisitsoeng ho pharmacology ho hlalosa lihlahisoa tse peli tse fapaneng tsa lithethefatsi, tse thehiloeng ts'ebetsong ea tsona le ts'ireletseho, li le joalo.
Tsamaiso ea US Food and Drug Administration (FDA) e hlalosa li-bioequivalence e le "ho se be le phapang e khōlō ka tekanyo le tekanyo eo motsoako o sebetsang kapa karolo e sebetsang ka eona meriana e ts'oanang le meriana kapa mekhoa e meng ea meriana e fumaneha setšeng sa ketso ea lithethefatsi ha e laoloa tekanyo e tšoanang ea molar'a tlas'a maemo a tšoanang le thuto e entsoeng hantle. "
Li-bioavailability le li-bioequivalence li amana haufi-ufi ka ho toba ha ho na le bioavailability e lekanyelitsoeng (e leng, ho bapisoa ha bioavailability ea lithethefatsi tse ling ho isa ho e 'ngoe) ke e' ngoe ea mehato e sebelisetsoang ho hlahloba lithethefatsi tsa bioquivalency.
Bakeng sa tumello ea FDA, lithethefatsi tse tloaelehileng li tlameha ho bonts'a nako ea ho tšepa tšepo ea 90% (CI) ka bobeli le tekanyo ea ho ba teng ha likokoana-hloko ha li bapisoa le tsa lihlahisoa tsa meriana.
> Mehloli:
> Muirhead, G .; Wuff, M ;; Fielding, A .; et al. "Likamano tsa Pharmacokinetic pakeng tsa sildenafil le saquinavir / ritonavir." British Journal ea Clinical Pharmacology. August 2000; 50 (2): 99-107.
> Pina, I .; Borland, J .; Arya, N .; et al. "Phello ea khalsiamo le tšepe e tlatsetsa ho pharmacokinetics ea > dolutegravir > litabeng tse phetseng hantle." Thuto ea Machaba ea bo15 ea Mesebetsi ea Meriana ea HIV le Hepatitis Therapy; Washington, DC; La 19-21 la la 19, 2014; e sa hlakang P_13.
> Tsamaiso ea US Food and Drug Administration (FDA). "Tataiso bakeng sa indasteri: Li-Bioavailability le Lithuto tsa Bioequivalence bakeng sa Lithethefatsi tsa Meriana e Laoloang ka Molao - Tlhahlobo e Ikhethang." Silver Springs, Maryland.