Emhlabeni wokuthuthukiswa kwezidakamizwa kanye ne-pharmacokinetics, ukubaluleka kokusebenzisa amakhithi ocwaningo athembekile nasezingeni eliphezulu angeke kweqiswe. Omunye umkhiqizo onjalo obalulekile yikhithi yama-microsomes esibindi somuntu, edlala indima ebalulekile ekulingiseni izinqubo zokugayeka kokudla emzimbeni womuntu. Kwa-IPHASE, sisebenza ngokukhethekile ekuhlinzekeni ngezinhlobonhlobo zemikhiqizo yocwaningo lwesayensi yempilo, okuhlanganisa ikhithi yama-microsomes esibindi somuntu, eklanyelwe ukusekela abacwaningi emzamweni wabo wokuthuthuka kwezokwelapha.
I-IPHASE iqale uhambo lwayo ngokwethula imikhiqizo yayo yokuqala ye-ADME (Absorption, Distribution, Metabolism, and Excretion) okuhloswe ngayo ukuthuthukisa izinqubo zokuhlolwa kwezidakamizwa kusenesikhathi. Phakathi neminyaka yocwaningo nokuthuthukiswa okuzinikele, siye sandisa kakhulu iminikelo yethu, siqinisekisa ukuthi amakhasimende ethu ayakwazi ukufinyelela kumathuluzi aphambili emikhakheni eyahlukene, okuhlanganisa ne-pharmacokinetics, i-pharmacology, i-microbiology, i-immunology, i-genetics, nemithi yomtholampilo. Ukuzibophezela kwethu ekwenzeni okuhle kubonakala kuphothifoliyo yethu ebanzi, manje ehlanganisa imikhiqizo engaphezu kuka-2,000 ezithuthukisiwe kusukela ezintweni ezinikezwa amaseli kuya ezintweni zokuhlola ubuthi be-genotoxicity.
Ikhithi yama-microsomes esibindi somuntu iyithuluzi elibalulekile ocwaningweni lwe-pharmacokinetic, ikakhulukazi uma kuziwa ekuqondeni ukuzinza kwe-metabolic kwabafuna izidakamizwa. Le kit yenza abacwaningi bakwazi ukuhlola izinqubo ze-metabolic izidakamizwa ezidlula kuzo esibindini somuntu, ukuhlola izici ezifana nomsebenzi we-enzyme kanye nokwakheka kwama-metabolites. Ngokusebenzisa ikhithi yethu yama-microsomes esibindi somuntu, ososayensi bangabikezela ngokunembile ukuthi izinhlanganisela zabo zizoziphatha kanjani emzimbeni womuntu, okuvumela ukuba kwenziwe izinqumo ezinolwazi ekuthuthukisweni nasekubunjweni kwezidakamizwa.
Kwa-IPHASE, siyaziqhenya ngokuqinisekiswa kwemikhiqizo yethu ngokumelene nezindinganiso zangaphakathi nezamazwe ngamazwe, okuhlanganisa imihlahlandlela ye-OECD ne-ICH. Lokhu kuzibophezela kuqinisekisa ukuthi ikhithi yethu yama-microsomes esibindi somuntu nokunye okunikezwayo kuhlangabezana nezindinganiso zekhwalithi ephezulu kakhulu, okuhlinzeka ngemiphumela ethembekile nephinde ikhiqizeke kumakhasimende ethu. Ngaphezu kwalokho, imikhiqizo yethu ithole iziqu kanye nezitifiketi zelungelo lobunikazi, kanye nokuqashelwa okubanzi okuvela kontanga bemboni, okuqinisa isithunzi sethu njengomhlinzeki othembekile emkhakheni wesayensi yezempilo.
Ngokungeziwe kukhithi yethu yama-microsomes esibindi somuntu, uhla lwethu lwemikhiqizo ehlukahlukene luhlanganisa amakhithi akhethekile afana nekhithi ye-plasma yekhwalithi ephezulu ye-IPHASE (Cynomolgus), ikhithi yokuqoqa igazi elincane elincane, namanye amathuluzi ahlukahlukene enzelwe izidingo ezithile zocwaningo. Le mikhiqizo ebanzi ivumela amakhasimende ethu ukuthi akhethe imikhiqizo efaneleka kakhulu ezinhlosweni zawo zocwaningo, ekugcineni athuthukise ukusebenza kahle kanye nemiphumela yezifundo zawo.
Kwa-IPHASE, siyaqonda ukuthi impumelelo yamakhasimende ethu incike kwikhwalithi yamathuluzi ocwaningo awasebenzisayo. Kungakho siqhubeka nokutshala imali ocwaningweni nasekuthuthukisweni komkhiqizo kuyilapho sinikeza ukusekelwa okukhethekile ngemva kokuthengisa ukuze siqinisekise ukuthi amakhasimende ethu angakwazi ukukhulisa inani lemikhiqizo yethu, okuhlanganisa nekhithi yama-microsomes esibindi somuntu. Ithimba lethu lochwepheshe elizinikele lihlala litholakala ukuze lisize amakhasimende ekukhetheni imikhiqizo efanele izidingo zawo ezithile kanye nokunikeza isiqondiso semikhuba engcono kakhulu okufanele iyilandele phakathi nokuhlolwa.
Sengiphetha, ikhithi yama-microsomes esibindi somuntu iyimpahla eyigugu kubacwaningi abahlola i-metabolism yezidakamizwa kanye ne-pharmacokinetics. Ukuzibophezela okungaguquki kwe-IPHASE kwekhwalithi kanye nokusungula izinto ezintsha kusibeka njengabahlinzeki abahamba phambili embonini yesayensi yezempilo. Hlola uhla lwethu olubanzi lwemikhiqizo namuhla futhi uthole umehluko ongawenza amathuluzi ocwaningo ekhwalithi ephezulu emisebenzini yakho yesayensi.
