版權(quán)說(shuō)明:本文檔由用戶提供并上傳,收益歸屬內(nèi)容提供方,若內(nèi)容存在侵權(quán),請(qǐng)進(jìn)行舉報(bào)或認(rèn)領(lǐng)
文檔簡(jiǎn)介
IdentifyingSurrogateEnvironmentstoMeetLocalFieldTrialRequirementsContentsofthePresentationWhatisaSurrogate?Whyisthisusefulforregulation?CanweidentifysurrogateenvironmentsforConfinedFieldTrials(CFTs)?(Ithinktheansweris“yes”)UsingasurrogateapproachtosatisfyCFTrequirementsWhatisaSurrogate?Merriam-WebsterDictionary“oneappointedtoactinplaceofanother”“Asubstitute”Inregulation,thisistypicallyasurrogateorganismIntendedtosubstituteforhumansorotherspeciesthataredifficulttotestinthelaboratorySurrogatesinRegulationTheuseofsurrogatespeciesiswellacceptedformanyregulatorypurposesDrugandpharmaceuticalevaluationsChemicalandpesticidetestingRegulatorydecisionmakingwouldnotbepossibleintheseareaswithoutuseofsurrogatesfortestingThisacknowledgestworealitiesYoucan’ttesteverythingdirectlyAlthoughasurrogatewillneverbeidenticaltothespeciesyoucareabout,anappropriatesurrogateisadequatetoensuresafetyIdentifyingSurrogatesforRegulatoryTestingThesurrogatemustbeanappropriatesubstituteforthepurposeofthetestDemonstratesimilaritytothespecies/subjectofinterestShowsimilarresponsesorshareparametersthatarerelevantforthetestresultTherefore,youneedtounderstandyourtestinordertoknowifyouhaveanappropriatesurrogateCanweidentifysurrogateenvironmentsforConfinedFieldTrials(CFTs)?ThesurrogateenvironmentapproachisalreadyappliedintheconductofCFTsSmallscaletrialsareextrapolatedtodrawconclusionsaboutcultivationinamuchlargerenvironmentHowever,manycountriesrequirein-countrytestingtosupportregulatoryassessmentsofGEplantsAlthoughpoliticalboundariesarenotparametersthatinfluencesthetestresultsWhataretherelevantparametersofaCFTenvironment?Ifwewanttoidentifysurrogateenvironments,wefirstneedtounderstandthetestsbeingperformedWhatarewetestinginCFTs?ThenweneedtoconsiderthecharacteristicsoftheenvironmentthatmayinfluencetheresultsofthosetestCFTsarecomparativeassessmentsGEPlantObservationsGrowthRateReproductionPestSuscept.DiseaseSuscept.PhysicalcharacteristicsoftheplantsConventionalComparatorWhatarethecomponentsoftheEnvironment?Biotic:allthelivingthingsMicroorganismsMacroorganismAbioticWeatherClimatePhysicalCharacteristicsConfinedFieldTrialDataDataTypicallyAddressesAgro-phenotypiccharacteristicsCollectedprimarilyforunintendedeffectsassessmentToverifytherearenochangesinreproductiveorgrowthhabitsAllthedataiscomparativeWithoneormorecomparatorsgrowninthesametrialOrtoknownreferencevarietiesDataTypicallydon’taddressBiodiversityinteractionsBioticinteractionsareprettytightlycontrolledunderfieldtrialconditionsPartoftheconfinementprotocolSometimesarthropodsurveysaredone–thesearegenerallylessinformativethanlaboratorydataMostoftheinformativedataforassessingrisktobiodiversityislaboratorydataorfrompublishedliteratureSoanappropriatesurrogateenvironmentShouldbeonewherewewouldexpectpair-wisecomparisonsbetweenaGEcropandtheconventionalparent(orothercomparator)toyieldthesameresults.TheecologyofthesiteshouldnotmatterBecauseitwillbeanagriculturalenvironmentunderconfinementconditionsLimitingbiologicalinteractionDiseasesandpestswillbecontrolledbecausetheyinterferewiththeresultsofthepair-wisecomparisonDemonstratingasimilarphysicalenvironmentshouldbeenoughtoestablishanappropriatesurrogateenvironmentforCFTsDemonstratingSimilarityinthePhysicalEnvironmentIdentifyanappropriatesurrogateenvironmentusingcharacteristicsofthephysicalenvironmentTherearemanywaysyoumightdothis:AnylocationthatcangrowacroparguablysharesphysicalcharacteristicsthatarerelevanttotheresultsofaCFTItmaybeenoughsimplytoknowthatyoucangrowthecropofinterestinbothlocationsAgro-climatesimilarityAmeasureofphysicalcharacteristicsincluding,forexample,growingdegreedays(GDD)seasonality,highandlowtemperaturesetc.ProvidesascientificallydefensiblerationaleforassertingthattheenvironmentsaresubstantiallythesameAgroclimateTherearemanydifferentAgroclimatezonationsavailableWehavechosentousetheGlobalEnvironmentStratification(GEnS)PubliclyavailableZonationishierarchicalBuiltondatafrompubliclyavailablesourcesNotbasedonmathematicalmodelingComparesfavorablewithotherzonations(seevanWartetal.2013)AgroclimateVisualizationUsingtheGlobalEnvironmentStratification(GEnS)UnitesStatesChinaComparingAgroclimatesBoththeUnitedStatesandChinaoccupyprimarilynortherntemperateclimatesFurther,bothcountriesarelargeandgeographicallydiverseIt’snotsurprising,therefore,thatweseethesameagroclimatezonesshowingupinbothcountries.ThisalsoexplainswhyyouseemanyofthesamecropsbeinggrowninbothcountriesSo,youwouldexpecttobeabletoidentifyappropriatesurrogateenvironmentsforCFTtesting.PracticalApplicationRationalplanningfortheconductoffieldtrialsSelectingfieldtrialsitesthatoccupyanagroclimatezonewithrelevanceforcountrieswherefutureriskassessmentswillbeconductedSatisfying“in-country”fieldtrialrequirementswithdatageneratedinsurrogateenvironmentsoutsideofthecountryEitherinoneormultiplecountries/locationswheretrialshavebeenpreviouslyconductedWhatelseisrequired?Regulatoryauthoritymustbeinterested/willingtomeetdatarequirementswithremotelycollecteddataLegalorregulatoryrequirementsarenotalwaysamenabletoascientificrationaleCountriesmayperceivesomeotherbenefittoconductingincountrytrialsIfacountryiswillingtousedatacollectedfromsurrogateenvironments,thosedatamustbecollectedincompliancewithregulatoryrequirementsRequirementsneedtobetransparent,anddeterminedinadvanceSpecific,hypothesisdriventestinginagivenenvironmentmaystillbewarrantedProvidedthereisaplausiblepathwaytoharmandtheexperimentbeingdoneisabletoprovideusefulinformationConclusionsItispossibletoapplyasurrogateapproachtomakeuseofremoteenvironmentstosatisfylocalfieldtrialrequirementsPre-requisitesforusingthesurrogateenvironmentapproach:Establishthattheenvironmentwherethetrialsareconductedisrelevantinthecountrywherethedatais
溫馨提示
- 1. 本站所有資源如無(wú)特殊說(shuō)明,都需要本地電腦安裝OFFICE2007和PDF閱讀器。圖紙軟件為CAD,CAXA,PROE,UG,SolidWorks等.壓縮文件請(qǐng)下載最新的WinRAR軟件解壓。
- 2. 本站的文檔不包含任何第三方提供的附件圖紙等,如果需要附件,請(qǐng)聯(lián)系上傳者。文件的所有權(quán)益歸上傳用戶所有。
- 3. 本站RAR壓縮包中若帶圖紙,網(wǎng)頁(yè)內(nèi)容里面會(huì)有圖紙預(yù)覽,若沒(méi)有圖紙預(yù)覽就沒(méi)有圖紙。
- 4. 未經(jīng)權(quán)益所有人同意不得將文件中的內(nèi)容挪作商業(yè)或盈利用途。
- 5. 人人文庫(kù)網(wǎng)僅提供信息存儲(chǔ)空間,僅對(duì)用戶上傳內(nèi)容的表現(xiàn)方式做保護(hù)處理,對(duì)用戶上傳分享的文檔內(nèi)容本身不做任何修改或編輯,并不能對(duì)任何下載內(nèi)容負(fù)責(zé)。
- 6. 下載文件中如有侵權(quán)或不適當(dāng)內(nèi)容,請(qǐng)與我們聯(lián)系,我們立即糾正。
- 7. 本站不保證下載資源的準(zhǔn)確性、安全性和完整性, 同時(shí)也不承擔(dān)用戶因使用這些下載資源對(duì)自己和他人造成任何形式的傷害或損失。
最新文檔
- 前列腺癌化療護(hù)理常規(guī)
- ELISA基礎(chǔ)知識(shí)和注意事項(xiàng)
- 疫苗接種副反應(yīng)
- 【AB卷】小學(xué)數(shù)學(xué)一年級(jí)上冊(cè)-第六單元檢測(cè)卷A(含答案)北師大版
- 2024年秋季學(xué)期新統(tǒng)編版道德與法治七年級(jí)課上冊(cè)教學(xué)件 第二單元 成長(zhǎng)的時(shí)空 第五課 和諧的師生關(guān)系 第1課時(shí) 走近老師
- 2024年秋季學(xué)期新人教版生物七年級(jí)上冊(cè)課件 第二章 動(dòng)物的類(lèi)群 2.2.2 第2課時(shí) 兩棲動(dòng)物和爬行動(dòng)物
- 蜂蜜產(chǎn)品原材料供應(yīng)與需求分析
- 運(yùn)動(dòng)護(hù)具產(chǎn)品市場(chǎng)需求分析報(bào)告
- 特種設(shè)備檢驗(yàn)檢測(cè)市場(chǎng)需求與消費(fèi)特點(diǎn)分析
- 熱敏記錄紙商業(yè)機(jī)會(huì)挖掘與戰(zhàn)略布局策略研究報(bào)告
- 網(wǎng)約車(chē)聯(lián)合經(jīng)營(yíng)協(xié)議書(shū)范本
- 2024至2030年中國(guó)燕麥片市場(chǎng)零售規(guī)模與投資策略研究報(bào)告
- 全民國(guó)防教育日踔厲奮發(fā)防控警報(bào)國(guó)防教育知識(shí)培訓(xùn)課件
- 人教版(2024)七年級(jí)地理上冊(cè)3.2《世界的地形》精美課件
- 技改革新方法與實(shí)踐理論考試題庫(kù)-上(單選題)
- 《軍事理論與軍事技能》全套教學(xué)課件
- 電梯每月電梯安全調(diào)度
- 2024年4月自考04184線性代數(shù)(經(jīng)管類(lèi))試題
- 工傷保險(xiǎn)先行支付申請(qǐng)表
- 《急危重癥護(hù)理學(xué)》理論考試題庫(kù)(核心500題)
- 法人代表、董事、經(jīng)理、監(jiān)事任職文件
評(píng)論
0/150
提交評(píng)論