Bioavailability - menene wannan? Bioavailability da kwayoyi

Bioavailability - ne adadin miyagun ƙwayoyi da cewa ya kai babban matsayi na mataki a cikin mutum ko dabba jiki. Wannan kalma tana nufin yawan rasa da kuma adana gina jiki da suke da amfani ga jiki. Saboda haka, a lokacin da wani babban mataki na bioavailability za a iya hukunci a kan wani karamin adadin rasa da warkewa Properties na wani magani.

Ta yaya ne wannan adadi?

A misali siffofin kwayoyi bioavailability nazarin saukar da kayyade girma na magani a cikin jini, Ina nufin da adadin abin da ya kai jijiyoyi. A hanyoyi daban-daban, da gabatar da shi yana da daban-daban Manuniya. Saboda haka, bioavailability bayan igiyar jini tsari kai 100%. Idan baka bioavailability faru, da ƙarar da aka ƙwarai rage saboda bai cika sha da kuma bazuwar daga cikin miyagun ƙwayoyi a cikin mutum aka gyara.

Wannan kalma ana amfani da pharmacokinetics yin lissafi da daidai sashi ga mãsu haƙuri da za a bi domin hanyoyi daban-daban na gwamnati zuwa wani kwayoyin.

Bioavailability yin amfani da matakai biyu:

1. Cikakkar.
2. Dangi.

A ra'ayi na cikakkar bioavailability

A cikakkar bioavailability - gwargwado sakamakon bincike na Comparative bioavailability na kwayoyi gudanar da wanin igiyar jini, Hanyar da kasancewa daga cikin miyagun ƙwayoyi, ba intravenously. Ya nuna yadda yankin karkashin kwana "girma - lokaci", rage tsawon "PPC." Domin gudanar da irin wannan hanya mai yiwuwa ne kawai a lokacin da yanayi irin na yin amfani da daban-daban dosages na hanyoyi daban-daban na gwamnati zuwa wani kwayoyin.

Don sanin yawan cikakkar bioavailability rike pharmacokinetic nazari da za'ayi, manufar ita kafin su sami kamanta analysis "miyagun ƙwayoyi girma game da lokaci" domin igiyar jini da kuma musamman Hanyar aiwatar. Saboda haka, cikakken bioavailability da kwayoyi - wannan AUC ga modified sashi samu a lokacin rarraba AUC musamman Hanyar gwamnati da kuma igiyar jini.

A ra'ayi na zumunta bioavailability

Dangi bioavailability - yana da Pep magani, ya halartar idan aka kwatanta da sauran jinsunan guda miyagun ƙwayoyi dauka a matsayin tushen ko ya shiga a cikin wani hanya. Base - igiyar jini hanya ne halin da cikakkar bioavailability.

Don samun adadin zumunta bioavailability a cikin jiki tambaya fihirisa, characterizing ƙara da miyagun ƙwayoyi a cikin jijiyoyi, ko a lokacin da tukar tumbi da fitsari bayan guda ko mahara amfani. Domin samun wani babban kaso na AMINCI lokacin da nazarin da binciken amfani da wani crossover Hanyar. Yana da damar cikakkiyar kawar da bambanci na da sakamakon samu tare da physiological kuma pathological jihohin da kwayoyin.

Abin da hanyoyin da ake amfani a kayyade da bioavailability?

Don sanin low bioavailability na cikin shirye-shiryen, ko high, da masana kimiyya amfani da wadannan dabaru:

1. Comparative bincike na canji a juz'i tsakanin binciken miyagun ƙwayoyi da kuma asali nau'i na da miyagun ƙwayoyi a cikin jini, ko fitsari. Wannan binciken da bayar da cikakkiyar har ƙayyade yawan cikakken bioavailability.
2. Ji na daban-daban kwayoyi gabatar a cikin jiki a cikin wannan hanya. Wannan dabara damar domin sanin zumunta bioavailability.
3. Don sanin zumunta bioavailability na girma ta hanyar bullo da kwayoyi a cikin hanyoyi daban-daban.
4. Nazarin girma matakin da sakamakon da miyagun ƙwayoyi a cikin jini, ko fitsari. An yi domin sanin zumunta bioavailability index.

Abũbuwan amfãni daga aikace-aikace na HPLC

HPLC - Wani Hanyar kayyade bioavailability - chromatography, wanda yana da wani high dace a aiki, ya yi amfani idan ya cancanta, rabuwa da hadaddun zuwa sauki abubuwa. Ana amfani da mafi akai-akai a cikin binciken na bioavailability, kamar yadda yana da wadannan m fasali:

1. A rashin kwanciyar hankali ya takaita ga zafin jiki a cikin karatu samfurori haka.
2. Shi ya sa ya yiwu don aiki tare da mai ruwa-ruwa mafita, wanda muhimmanci rage tsawon lokaci na nazarin da inganta mataki na shirye-shiryen da nazarin halittu samfurori.
3. Babu bukatar da shiri na Kalam na binciken magani.
4. A kayan aiki amfani da wannan hanya na karatu, yana da kyau kwarai yawan aiki da kuma yadda ya dace.

Wannan na iya samun wani tasiri a kan total bioavailability?

A misali adadin da miyagun ƙwayoyi, an ingested da nevnutrivennym, shi ne kasa da 1. Duk da haka, shi yana iya zama ko da kasa saboda wasu ƙarin nuances. Saboda haka, abubuwan da shafi cikin bioavailability - shi ne:

1. The jiki Properties daga cikin miyagun ƙwayoyi.
2. Nau'i na magani da kuma tsawon lokaci na makamantanta a jiki.
3. Hours - kafin cin abinci ko bayan.
4. Speed na tsarkakewa da gastrointestinal fili.
5. A tasiri na sauran kwayoyi a kan magani.
6. A dauki kudi ga wasu abinci.

bioequivalence

Wani iri-iri yana da wani bioavailability, bioequivalence ne. Wannan ra'ayi ya taso dangane da pharmacokinetic da biofarmatsionnyh bincike, a lokacin da shi da aka samu da cewa rashin daidaito warkewa kwayoyi dauke da wannan abu yana da dangantaka ta kai tsaye tare da bambanci a bioavailability.

Saboda haka, bioequivalence - shi ne don tabbatar da jini da kyallen takarda da wannan yawan abubuwa.

Key Manuniya na bioequivalence

Don sanin bioequivalence na da wadannan sigogi da ake amfani a cikin formulations:

1. Karuwan ko mafi cikakken bioavailability na alluna a cikin jijiyoyi. Bincika da mãkirci, a cikin abin da biyu masu lankwasa wakilci adadin miyagun ƙwayoyi gudanar da hanyoyi daban-daban, da kuma mike layin wakiltar m girma daga cikin miyagun ƙwayoyi da ake bukata domin warkewa sakamako.
2. A tsawon lokaci na babban abun ciki na miyagun ƙwayoyi. Wannan nuna alama nuni bugun tsotsa da warkewa effects a jiki. Don fahimci ainihin wannan nuna alama iya zama misali na kwayoyin maganin barci. A kadan warkewa sakamako shi zai yi a rabin awa, ko na 2 - dangane da irin shirye-shiryen. Hypnotic warkewa aiki zai yi daidai da wannan siffar, na 5 zuwa 8 hours. Saboda haka, duk da kama a sakamako, wani nau'i za a iya amfani da rigakafin barci cuta, da kuma na biyu - a kananan sauran lokaci.
3. Canza adadin miyagun ƙwayoyi a cikin jini bayan wani lokaci.

Launch da miyagun ƙwayoyi a aiwatar

Kafin ka fara shiri don sayarwa, ya kamata ka bincika bioavailability da bioequivalence kwayoyi, yana da muhimmanci sosai. Don wannan karshen, da wadannan hanya ake yi:

1. A manufacturer su musulunta aikace-aikace da jihar pharmacological kwamitin so ya saki ya magani a aiwatar. Office, bi da bi, ya bada izinin gudanar da bioequivalence nazarin yin amfani da biyu samfurori: data kasance da sabon.
2. A binciken da za'ayi a kan al'ada ko ciwon wani cuta masu sa kai a wannan sashi. Bugu da kari, kowane nazari biya domin ta manufacturer.

Wannan hanya ne da za'ayi a cikin na musamman likita cibiyoyin ko dakunan gwaje-gwaje da taimako na waje masana. A zabin 'yan takara domin gwaje-gwaje da dole ne a dauki la'akari da wadannan bukatun:

1. Su total number bazai kasa da 12. m sau lokacin da yawan masu sa kai qara zuwa 25. A cikin wannan na faruwa yafi a cikin hali na high Inter-mutum bambancin a cikin pharmacokinetic sigogi.
2. Agaji dole isa rinjaye da kuma ba zama ya fi shekaru 60.
3. пола, возраста и роста. The nauyi na kowane mutum ba zai kasa ko fiye da 20% na manufa nauyi ga wani ba jinsi, shekaru da kuma tsawo.
4. Ba a yarda da bincike kan mutanen da fama da zuciya da jijiyoyin jini cututtuka, ko na kullum. The kawai togiya ne cewa wani rukuni na jama'a da suka bayar da shawarar yin amfani da wannan magani.

Ta yaya ne da horo na masu sa kai?

Kafin ka shiga wani amsa form domin binciken, tabbatas da bioavailability na abu, kowane mai sa kai zata sami wadannan sa na bayanai:

1. A farko nazari haƙiƙa.
2. A tsawon lokaci da hanya.
3. Babban pharmacological data game da miyagun ƙwayoyi.
4. gabatarwar Hanyar baka magani.
5. A amfani sashi.
6. Exposure zuwa kwayoyi a jiki.
7. Ko rashin amfani wannan miyagun ƙwayoyi.
8. A nuances mulki a cikin bincike tsari.
9. Sharuddan biyan bashin da inshora siyasa.

Da zarar mai sa alamu wata kwangila da kuma wani sirri yarjejeniya, da masu bincike da za'ayi cikakken kiwon lafiya jarrabawa. Yana hada da:

1. Janar dubawa likitoci.
2. Analysis na jini da kuma fitsari.
3. Jini Biochemistry.
4. A jini gwajin cutar HIV, syphilis kuma hepatitis.
5. Pregnancy a mata.

Kowane jam'iyya ne sanye take da duk abin da ake bukata domin sauki binciken. Bugu da ƙari kuma, wani kamfanin inshora ne wata yarjejeniya game da yadda za a samu inshora a cikin taron na kasa gwaji. Bugu da ƙari, shawarce da yanayi da kuma adadin albashin.

Wanda aka yarda ya yi nazarin?

Aiki tare da masu sa kai daukawa bincike. Ya dole ne hadu da wadannan yanayi:

1. The bincike yana da hakkin ga ka'idar da yi dukkan sinadaran da kuma pharmacological filayen.
2. A kan hannayensa ya dole ne a takardar shaidar mana ƙarshe.
3. The bincike dole ne cikakken fahimtar abin da yake cikin bioavailability na miyagun ƙwayoyi (wannan yana da muhimmanci) da kuma irin magani ya na da koya.

Bugu da kari wani bincike a cikin ƙungiyar dole hada da nas. Aikinsu sun hada da:

1. Sa idanu da kiwon lafiya na marasa lafiya.
2. Yin gwamnatin lokacin.
3. Girkawa catheters.
4. A karbo daga wani adadin na jini domin bincike a cikin marasa lafiya.

Bugu da ari, a cikin ƙungiyar sun hada da:

1. Analytics da kuma masu gyara.
2. Pharmacokinetics.
3. LISSAFI.

Jawo sama da wani rahoto a kan aikin

Bayan kammala dukkan bincike ayyuka principally likita sanya daga takarda, wadda ya kamata gani da wadannan abubuwa:

1. A general shirin pharmacological karatu. Yana dole ne dole a yarda da pharmacological Jihar kwamitin.
2. All data game da masu sa kai. alƙaluma, anthropometric da kuma na asibiti data dole ne a kayyade. A karshen nuna idan hannu na marasa lafiya.
3. Serial lambobi da kuma sunayen Manufacturing kamfanoni, kazalika da lokacin da suka warkewa effects.
4. Bambance-bambancen Drug Administration da kuma tasiri sashi.
5. Hanyar zabi nazarin halittu abu da kuma pre-aiki.
6. Jerin manazarta da gabatarwar metrological yi da kuma zanga-zanga chromatogram.
7. Cikakken bayani na duk tafiya pharmacokinetic nazari da kuma kimantawa na bioequivalence. Yana kuma ya bada jerin sunayen dukan shirye-shirye amfani a cikin binciken.
8. A sakamakon ganewa na adadin kwayoyi a nazarin halittu samfurori.
9. Medical masu sa kai maps da mutum profiles.
10. Sakamako na pharmacokinetic nazarin watsawa dabi'u da za a yi amfani da kima na bioequivalence.

Hanya don bioequivalence

A binciken a kan bioavailability na kwayoyi ne da za'ayi a cikin wannan sashi a biyu formulations: da samu da kuma asali. A cikin hali na aikace-aikace da nazari da dama kwayoyi bincike da aka dabam ga kowane.

A lokaci tazara tsakanin liyafar na asali Generic da kuma ayyana tsawon kawar da miyagun ƙwayoyi a cikin jiki, m janye lokaci. Ya kamata a daidaita wani talakawan na 6 lokaci na m kau. Materials amfani ga nazari na iya zama jini, magani ko jini. An dauka daga wani jijiya a cikin crook na gwiwar hannu ta catheter. Samfur ya kamata a yi sau uku:

1. A lokacin girma na farko abun ciki na shirye-shiryen. Ya kamata a game da maki 3 kan kwana "taro - lokaci".
2. A lokacin babban sha. Yana amfani game da 5 da maki.
3. A lokacin malabsorption. Yana amfani kamar maki 3.

binciken lokaci za a iya daukan m, idan darajar da yankin karkashin kwana "taro - lokaci" a nesa daga ƙasa har zuwa na karshe samfurin ne game da 80%.