Ọdịdị nke bioavailability na bioequivalence bụ okwu ndị e ji mee ihe na nkà mmụta ọgwụ na-akọwa ụdị omume na ihe onwunwe nke ngwaahịa ọgwụ.
Bioavailability na- akọwa onye ntinye ọgwụ nke ahụ na-arụ ọrụ na ọbara ọbara mgbe ọ na-eji ọgwụ emepụta ya, n'ụzọ ọ bụla ma ọ bụ ihe ọ bụla ọzọ (dịka, nkwụsị, sublingual, nasal, transdermal, wdg.)
N'iji ya kwuo, ọgwụ a na-ebunye na-emepụta ihe nwere 100% ebe ọ bụ na ọ na-enyefe ya n'ime ọbara.
E nwere ọtụtụ ihe nwere ike imetụta ọgwụ bioavailability. Ha gụnyere, n'etiti ihe ndị ọzọ:
- Njirimara anụ ahụ nke ọgwụ ọjọọ, gụnyere ọkara ndụ ọkara
- Ngwunye ọgwụ ọjọọ (dịka, ntọhapụ ozugbo, ntọhapụ oge)
- Ahụike nke ọrịa nke onye ọrịa
- Afọ nke onye ọrịa, nke nwere ike imetụta ọsọ nke metabolism
- Ma eji ọgwụ ma ọ bụ na-enweghị nri
- Akụrụ (akụrụ) na ọrụ hepatic (imeju), nke na-emetụta njedebe ọgwụ ọjọọ
Mkparịta ụka na ọgwụ ndị ọzọ ma ọ bụ nri pụkwara igbochi bioavailability. Dịka ọmụmaatụ, ọgwụgwọ HIV / AIDS , dịka ọmụmaatụ, Norvir (ritonavir) ọgwụ antiretroviral- iji "bulie" ọgwụ ndị ọgwụ ọgwụ ndị ọzọ ọgwụ nje HIV- nwere ike ime ka usoro ọgwụgwọ dị ka Viagra (sildenafil citrate) dị . N'ime ime nke a, ọ nwere ike ịgbasawanye ọkara ndụ Viagra ka ọ na-ebuli mmetụta ndị dị elu elu.
N'aka nke ọzọ, antacids na-ejupụta na magnesium- na aluminom (dị ka Tums ma ọ bụ Mmiri nke Magnesia) nwere ike belata ikikere nke ọtụtụ ọgwụ nje HIV mgbe a na - ewere ha n'otu oge - site na ọgwụ 74 dị ka Tivicay (dolutegravir) - na, n'ime otú ahụ, nwere ike imebi ihe mgbaru ọsọ nke ọgwụgwọ.
A na-eji usoro ọgwụ ọjọọ eme ihe na-akọwa ụdị ọgwụ ọjọọ abụọ dị iche iche, nke dabeere na nrụpụta ọrụ na nchekwa ha, bụ otu ihe ahụ.
Nchịkwa nri na ọgwụ ọjọọ nke United States (FDA) na-akọwa njedebe dị ka "enweghi ihe dị ịrịba ama na ọnụego na njedebe nke ihe mgbochi ma ọ bụ arụ ọrụ na-arụ ọrụ ọgwụ ma ọ bụ ihe ndị ọzọ na-emepụta ọgwụ na saịtị nke usoro ọgwụ ọjọọ mgbe a na-eme ya na otu ụdị ọgwụgwọ ahụ n'okpuru ọnọdụ ndị dị otú ahụ na nyocha nke e mere n'ụzọ kwesịrị ekwesị. "
Ọdịdị dị ndụ na bioequivalence bụ ihe jikọrọ ya na ihe dị ka mkpụrụ ndụ (bụ, bioavailability na-atụnyere otu ọgwụ na onye ọzọ) bụ otu n'ime ihe ndị a na-eme iji nyochaa ọgwụ bioequivalency.
Maka nkwenye FDA, ọgwụ ọjọọ ga-egosipụta ọnụọgụ obi 90% (CI) n'ogologo ma ọnụego nke bioavailability tụnyere nke sitere na ọgwụ eji eme ihe.
> Isi mmalite:
> Muirhead, G .; Wuff, M .; Nhazi, A .; et al. "Njikọ ọgwụ pharmacokinetic n'etiti sildenafil na saquinavir / ritonavir." British Journal of Clinical Pharmacology. August 2000; 50 (2): 99-107.
> Abụ, I .; Borland, J .; Arya, N .; et al. "Mmetụta nke calcium na mgbakwunye ígwè na pharmacokinetics nke > dolutegravir > na isiokwu ndị siri ike." 15th International Workshop on Clinical Pharmacology of HIV and Hepatitis Clinication; Washington, DC; Mee 19-21, 2014; nkịtị P_13.
> Nchịkwa nri na ọgwụgwọ na United States (FDA). "Nduzi maka Ahịa: Nyocha na Bioequivalence maka Ngwá Ọrụ Na - ahụ Maka Ọgwụ Ọjọọ - Echiche Nzuzo." Silver Springs, Maryland.