药物临床试验质量管理-广东共识-2014年-

···2014、1．/CＲO、、SMO、、、、。2．。、1．。2．《》《》。3．/SOP、。、/CＲO1．2．3．4．GCP476、25．6．7．“－”。、1．PI、2．、GCP3．、4．GCP26SAE5．SOP6．GCP27、、、、7．、、8．PI、9．、CＲF、、1．2．GCP123．、4．－、/1．、、、2．、、3．、、4．5．、6．、、CＲF、、、155·541·20153253PharmacyToday2015MarchVol．25No．3rison＇sPrinciplesofInternalMedicineM18thed．NewYorkMcGraw-HillProfessional2011．50LabargaPBarreiroPMartin-CarboneroLetal．Kidneytu-bularabnormalitiesintheabsenceofimpairedglomerularfunc-tioninHIVpatientstreatedwithtenofovirJ．AIDS2009236689-696．51MarcellinPChangTTLimSGetal．Long-termefficacyandsafetyofadefovirdipivoxilforthetreatmentofhepatitisBeantigen-positivechronichepatitisBJ．Hepatology2008483750-758．52PolSLamperticoP．First-linetreatmentofchronichepatitisBwithentecavirortenofovirin‘real-life’settingsfromclinicaltrialstoclinicalpracticeJ．JViralHepat2012196377-386．53LiawYFKaoJHPiratvisuthTetal．Asian-Pacificconsen-susstatementonthemanagementofchronichepatitisBa2012updateJ．HepatolInt20126531-561．54．J．2009115346-350．55Anonymous．FDApregnancyclassdefinitions．＜http//en．wikipedia．org/wiki/Pregnancy_category/＞2010accessed08．10．56HepatitisBchronicDiagnosisandmanagementofchronichepatitisBinchildrenyoungpeopleandadults．June2013．NICEclinicalguideline165．guidance．nice．org．uk/cg165．57JonasMMBlockJMHaberBAetal．TreatmentofchildrenwithchronichepatitisBvirusinfectionintheUnitedStatespatientselectionandtherapeuticoptionsJ．Hepatology2010522192-2205．58．2010J．2011411-13．1457．、/CＲOPI/CＲOPI8．、、9．10．、、、11．、/SOP12．。、、。、。、、。·551·20153253PharmacyToday2015MarchVol．25No．3