Isilingo Esisha Somtholampilo Se-Opioid Use Disorder

A BAMBA MahhalaRelease 1 | eTurboNews | eTN
Ibhalwe ngu Linda Hohnholz

I-Universal Ibogaine Inc. inkampani yesayensi yezempilo enomgomo wokuthuthukisa nokuletha ukunakekelwa kokulutheka okugxiliswe ku-ibogaine ngokwemithi, yethule ozakwethu benhlangano yocwaningo lwenkontileka abazovumela ukuthi kwenziwe ukuhlola komtholampilo okuhleliwe kwe-UI e-Canada, kuncike ekugunyazweni okudingekayo yi-Health Canada. I-UI okwamanje isebenza nabalingani bayo be-CRO ukuze iqedele umklamo wocwaningo we-UI ngaphambi komhlangano olindelwe wesicelo sokuhlolwa kwangaphambi komtholampilo ozobanjwa maduze ne-Health Canada.

I-UI ikhethe i-Intrinsik Corp., inkampani yezokulawula eyaziwa emhlabeni wonke, ukuhlinzeka ngamasu okulawula nokusekelwa ekulungiseni nasekuthunyelweni kwesicelo se-UI's Canadian Clinical Trial Application, kanye nokulandelela nokuqapha uma Kutholakala Incwadi Yokuphikisa Kwabezempilo. Canada. I-Intrinsik yakhiwe ithimba elinolwazi eliqhube amakhulukhulu ezivivinyo zemitholampilo eziyimpumelelo kanye nezicelo zemithi emisha eziphenywayo futhi selihlanganyele ngokuhlanganyela ekufakweni kwezicelo ezintsha zokuthengisa izidakamizwa ezingaphezu kuka-20. Leli qembu linabasebenzi bezindaba zokulawula abangaphezu kwe-25 abazinze endlunkulu yalo yaseCanada esendaweni enkulu yaseToronto, kanye nolwazi olungenakuqhathaniswa nolwazi oluhlobene ne-Central Nervous System Disorders (CNS: indawo yokwelapha lapho umlutha kanye nokuphazamiseka kwengqondo).

Ukwesekwa kokuthuthukiswa kwengqikithi yephakheji ye-CTA, kanye nokusebenza ekugcineni kokuhlolwa komtholampilo ngokwako, kunikezwa ithimba elisezingeni lomhlaba e-CATO Research Canada Inc. Ithimba lochwepheshe be-CATO SMS lineminyaka engaphezu kuka-30. ' ukuzizwisa kokuthuthukisa ukuklama nokwenza izivivinyo zomtholampilo zezinkampani zesayensi yezempilo ezifana ne-UI. I-CATO SMS yenze ngempumelelo izinhlolo zokwelashwa ezingaphezu kuka-500 emazweni angaphezu kwama-25 futhi ibhalise iziguli ezingaphezu kuka-60,000 ezindaweni ezingaphezu kuka-5,500.

Ithimba le-CATO SMS lokubandakanya, kanye nethimba le-UI, libandakanya ochwepheshe abahlukahlukene e-Canada, e-US naseYurophu, ehlinzeka ngobuchwepheshe obubalulekile kusukela kumiklamo yocwaningo lwezokwelapha kuya ku-biostatistics kuya ekusebenzeni komtholampilo (isib. , ukuphathwa kwedatha, njll.). Iminikelo ye-CATO SMS izophinde ihlanganise nokuhlaziywa kanye nokuhlanganiswa kwedatha yomhlaba wangempela nobufakazi (“RWD” kanye “RWE”, ngokulandelana) okuvela ekusetshenzisweni kwe-ibogaine ekwelapheni isifo sokusebenzisa i-opioid ezigulini ezingaba ngu-200 ezike zalashwa. ukwelashwa eCancun, eMexico nguzakwethu onelayisensi ye-UI – Clear Sky Recovery Cancun SA de CV. I-UI ikholelwa ukuthi ukwethulwa kwe-RWD ne-RWE njengengxenye yephakheji ye-CTA kuzoqinisa isicelo, ikakhulukazi isimangalo sokuqala sokuphepha, futhi sihambisana neziqondiso ezivelayo zabalawuli, njenge-US Food and Drug Administration (“FDA”), ukuvuma nokuhlanganisa i-RWD ne-RWE ekuthuthukisweni komtholampilo, futhi ngokuvamile emithini esekelwe ebufakazini.   

Okokugcina, i-UI ihlanganisa izikhungo zezemfundo nezokwelapha ezivelele ukuze zisekele i-CTA ku-Health Canada, futhi zisebenze njengezizinda zokwenza ukuhlolwa komtholampilo kokugcina. Ngokuphawulekayo, i-UI ihlanganyele nehhovisi locwaningo lesikhungo semfundo nokufundisa esizinze eCanada esihamba phambili endaweni yezokwelapha yokulutheka ukuze sisekele ukwakheka kwephrothokholi yocwaningo futhi sidale intshisekelo ekukhethweni kwesizinda sokuhlolwa.

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Linda Hohnholz

Umhleli omkhulu we eTurboNews ezinze eTN HQ.

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