{"id":53712,"date":"2021-05-10T11:46:32","date_gmt":"2021-05-10T09:46:32","guid":{"rendered":"https:\/\/www.oncomed.cz\/?post_type=studies&p=53712"},"modified":"2022-02-15T11:36:44","modified_gmt":"2022-02-15T10:36:44","slug":"zavadeni-problematickych-analytickych-metod-od-vyrobcu-ucinnych-latek-ze-zemi-tretiho-sveta","status":"publish","type":"studies","link":"https:\/\/www.oncomed.cz\/cs\/blog\/zavadeni-problematickych-analytickych-metod-od-vyrobcu-ucinnych-latek-ze-zemi-tretiho-sveta\/","title":{"rendered":"zav\u00e1d\u011bn\u00ed analytick\u00fdch metod od v\u00fdrobc\u016f \u00fa\u010dinn\u00fdch l\u00e1tek ze zem\u00ed t\u0159et\u00edho sv\u011bta"},"content":{"rendered":"
\n

Pozad\u00ed problematiky<\/h3>\n

V\u00a0r\u00e1mci zav\u00e1d\u011bn\u00ed alternativn\u00edch API je \u010dasto pot\u0159eba sou\u010dasn\u011b zav\u00e9st i in-house analytick\u00e9 metody pro specifick\u00e1 zbytkov\u00e1 rozpou\u0161t\u011bdla pou\u017eit\u00e1 v\u00a0kroc\u00edch synt\u00e9zy \u00fa\u010dinn\u00e9 l\u00e1tky nebo specifick\u00e9 ne\u010distoty, kter\u00e9 jsou pot\u0159eba stanovovat v\u00a0r\u00e1mci vstupn\u00ed anal\u00fdzy v\u00a0nov\u011b zav\u00e1d\u011bn\u00e9 API. Z\u00a0d\u016fvodu snadn\u011bj\u0161\u00edho a rychlej\u0161\u00edho postupu registrace je v\u00a0hodn\u00e9 pou\u017e\u00edt ji\u017e zaregistrovan\u00e9 metody od v\u00fdrobce API. Tento p\u0159\u00edstup v\u011bt\u0161inou preferuj\u00ed i na\u0161i z\u00e1kazn\u00edci. Bohu\u017eel zaregistrovan\u00e9 metody, kter\u00e9 dostaneme od v\u00fdrobc\u016f API, a to hlavn\u011b z\u00a0\u010c\u00edny nebo Indie, se \u010dasto ukazuj\u00ed jako velmi problematicky validovateln\u00e9.<\/p>\n<\/div>\n<\/div>\n\n\n\n\n

\"\"<\/figure><\/div>\n\n\n
\n

Co je pro n\u00e1s v\u00fdzvou?<\/h3>\n

Posledn\u00ed zku\u0161enost se zav\u00e1d\u011bn\u00edm analytick\u00e9 metody pro specifick\u00e1 zbytkov\u00e1 rozpou\u0161t\u011bdla dopadla tak, \u017ee ji\u017e v\u00a0r\u00e1mci p\u0159edb\u011b\u017en\u00e9ho testov\u00e1n\u00ed metody bylo jasn\u00e9, \u017ee chromatografick\u00e9 nastaven\u00ed nen\u00ed ide\u00e1ln\u00ed a sama metoda ji\u017e vykazovala n\u011bkolik probl\u00e9m\u016f. Z\u00e1kazn\u00edk i p\u0159es tyto informaci trval na zvalidov\u00e1n\u00ed zaregistrovan\u00e9 CEP metody. V\u00a0r\u00e1mci u\u0161et\u0159en\u00ed \u010dasu a zv\u00fd\u0161en\u00ed \u0161ance na \u00fasp\u011b\u0161n\u00e9 zvalidov\u00e1n\u00ed metody jsme vyu\u017eili i na\u0161e extern\u00ed laborato\u0159e, kter\u00e9 disponuj\u00ed jin\u00fdm p\u0159\u00edstrojov\u00fdm vybaven\u00edm, abychom p\u0159\u00edpadn\u011b vybrali plynov\u00fd chromatograf, kter\u00fd bude pro tuto metodu nejvhodn\u011bj\u0161\u00ed. Nakonec prvotn\u00ed probl\u00e9my s\u00a0p\u0159esnost\u00ed n\u00e1st\u0159ik\u016f a hor\u0161\u00edmi chromatografick\u00fdmi parametry se poda\u0159ilo nejl\u00e9pe vy\u0159e\u0161it v\u00a0na\u0161\u00ed intern\u00ed laborato\u0159i.<\/p>\n

Zb\u00fdvalo ji\u017e vy\u0159e\u0161it jen tvar p\u00edku jednoho zbytkov\u00e1 rozpou\u0161t\u011bdla, kter\u00fd ve vzorku s\u00a0API byl lehce deformovan\u00fd a vykazoval v\u00fdraznou nesymetrii. Z\u00a0dal\u0161\u00edho testov\u00e1n\u00ed vyplynulo, \u017ee deformace p\u00edk\u016f je zp\u016fsobena spojen\u00edm dvou rozpou\u0161t\u011bdel. Jedno rozpou\u0161t\u011bdlo bylo p\u0159\u00edtomno ve vzorku a druh\u00e9 vznikalo v\u00a0procesu p\u0159\u00edpravy vzorku dle registrovan\u00e9 CEP metody. V\u00fdsledkem testov\u00e1n\u00ed bylo, \u017ee metoda je neselektivn\u00ed, a tud\u00ed\u017e nepou\u017eiteln\u00e9 pro po\u017eadovan\u00fd \u00fa\u010del. Tyto podklady byly p\u0159ed\u00e1ny z\u00e1kazn\u00edkovy, kter\u00fd je obratem konzultoval s\u00a0v\u00fdrobcem API. Na z\u00e1klad\u011b t\u011bchto podklad\u016f, v\u00fdrobce API p\u0159iznal, \u017ee o tomto probl\u00e9mu v\u00ed a \u017ee to moment\u00e1ln\u011b \u0159e\u0161\u00ed. Po tomto zji\u0161t\u011bn\u00ed jsme se se z\u00e1kazn\u00edkem domluvili na v\u00fdvoji nov\u00e9 analytick\u00e9 metody v\u00a0na\u0161\u00ed laborato\u0159i.<\/p>\n

Za n\u011bkolik t\u00fddn\u016f se poda\u0159ilo \u00fasp\u011b\u0161n\u011b vyvinout a pln\u011b zvalidovat novou analytickou metodu, kter\u00e9 byla mnohem robustn\u011bj\u0161\u00ed, snadn\u011bj\u0161\u00ed na p\u0159\u00edpravu a m\u011bla v\u00fdrazn\u011b krat\u0161\u00ed \u010das anal\u00fdzy, kter\u00fd v\u00fdrazn\u011b do budoucna u\u0161et\u0159\u00ed \u010das a n\u00e1klady p\u0159i rutinn\u00edm pou\u017e\u00edv\u00e1n\u00edm t\u00e9to metody.<\/p>\n<\/div>\n<\/div>\n\n\n\n\n

\"\"<\/figure><\/div>\n\n\n
\n

\u0158e\u0161en\u00ed<\/h3>\n

Na z\u00e1klad\u011b na\u0161ich zku\u0161enost\u00ed doporu\u010dujeme z\u00e1kazn\u00edk\u016fm, v\u00a0p\u0159\u00edpad\u011b zav\u00e1d\u011bn\u00ed metod od v\u00fdrobc\u016f API z\u00a0t\u0159et\u00edch zem\u00ed, intern\u011b vyvinout novou analytickou metodu. I p\u0159es teoreticky v\u011bt\u0161\u00ed \u00fasil\u00ed s\u00a0v\u00fdvojem metody, je nakonec ve v\u011bt\u0161in\u011b p\u0159\u00edpad\u016f toto \u0159e\u0161en\u00ed nejrychlej\u0161\u00ed a z\u00e1rove\u0148 nejlevn\u011bj\u0161\u00ed. V\u00a0p\u0159\u00edpad\u011b validace analytick\u00e9 metody od v\u00fdrobce API v\u017edy trv\u00e1me na d\u016fkladn\u00e9m p\u0159edb\u011b\u017en\u00e9m testov\u00e1n\u00ed metody, abychom se vyhnuli probl\u00e9m\u016fm p\u0159i validaci metody.<\/p>\n

 <\/p>\n<\/div>\n<\/div>\n\n","protected":false},"author":3,"featured_media":0,"template":"","meta":{"_acf_changed":false,"advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories_studies":[13],"class_list":["post-53712","studies","type-studies","status-publish","hentry"],"acf":[],"aioseo_notices":[],"featured_img":false,"coauthors":[],"author_meta":{"author_link":"https:\/\/www.oncomed.cz\/cs\/author\/jorova\/","display_name":"Zuzana Jorov\u00e1"},"relative_dates":{"created":"Posted 5 roky ago","modified":"Updated 4 roky ago"},"absolute_dates":{"created":"Posted on 10. 5. 2021","modified":"Updated on 15. 2. 2022"},"absolute_dates_time":{"created":"Posted on 10. 5. 2021 11:46","modified":"Updated on 15. 2. 2022 11:36"},"featured_img_caption":"","tax_additional":{"categories_studies":{"linked":["\u010cl\u00e1nky<\/a>"],"unlinked":["\u010cl\u00e1nky<\/span>"],"slug":"categories_studies","name":"Kategorie blogu"},"translation_priority":{"linked":[],"unlinked":[],"slug":"translation_priority","name":"Translation Priorities"}},"series_order":"","_links":{"self":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/53712","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies"}],"about":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/types\/studies"}],"version-history":[{"count":1,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/53712\/revisions"}],"predecessor-version":[{"id":54114,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/53712\/revisions\/54114"}],"wp:attachment":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/media?parent=53712"}],"wp:term":[{"taxonomy":"categories_studies","embeddable":true,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/categories_studies?post=53712"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}