藥質(zhì)量控制研究和質(zhì)量標準制訂之漫談(已修改)
2025-06-07 18:22 本頁面
【正文】 新藥質(zhì)量控制研究和質(zhì)量標準制訂之漫談中國醫(yī)學科學院藥物研究所General R amp。D Process TargetIdentificationAssay DevelopmentLead IdentificationLeadOptimizationPhase II Phase III Filing LaunchPhase IDevelopmentPredev.Med. ChemistryDMPKAnalyticsDevelopment StrategyCovered topicsBiology / PharmacologyInvolved disciplinesDescription of deliverables and project review process for all major decision points in Ramp。D? Roles and responsibilities of stakeholders in Ramp。D Project Review Process? Deliverables for project team and key questions / criteriato be evaluated by decision mittees? Involved disciplines: all major Ramp。Ddisciplines from Target Identification through StartofDevelopmentDescription of activities/work packages and project milestones to optimize cycle times ? Activities in Drug Substance and Drug Productdevelopment? Development process from Predevelopment through product launch? Involved disciplines: mainly Chem./Pharmaceutical Development, Processing and ManufacturingPharmaceutical DevelopmentChemical DevelopmentChem. and Pharm. Processing / Manuf.ToxicologyDDSThe Roles of Structure Analysis Group in drug developmentPhase III Launch Post launchDrug Discovery PC amp。 Ph IPD Ph IISupport Toxicology and other activitiesCofA for Tox. Lot potential impuritiesSupport preformulation Support IND amp。 CTAA Full CofA preliminary reference standardIND Proof of Structure Synthetic impuritiesPotential degradation productRelease testingSupport formulationSupport NDAQualify Primary Reference Standard NDA proof of StructureForced Degradation studyImpurities and Degradation productRelease testingLeachablesClinical supplies testingInvestigation of OOS Support MarketingComplaintsCounterfeit Problem Solving in All Phases !!!新藥安全、有效、可控新藥分類o 化學藥品o 中藥、天然藥物o 生物制品化學藥品未在國內(nèi)外上市銷售的藥品：（ 1）通過合成或者半合成的方法制得的原料藥及其制劑；（ 2）天然物質(zhì)中提取或者通過發(fā)酵提取的新的有效單體及其制劑；（ 3）用拆分或者合成等方法制得的已知藥物中的光學異構(gòu)體及其制劑；（ 4）由已上市銷售的多組份藥物制備為較少組份的藥物； （ 5）新的復(fù)方制劑。改變給藥途徑且尚未在國內(nèi)外上市銷售的制劑。已在國外上市銷售但尚未在國內(nèi)上市銷售的藥品：（ 1）已在國外上市銷售的原料藥及其制劑；（ 2）已在國外上市銷售的復(fù)方制劑；（ 3）改變給藥途徑并已在國外上市銷售的制劑。改變已上市銷售鹽類藥物的酸根、堿基（或者金屬元素），但不改變其藥理作用的原料藥及其制劑 。改變國內(nèi)已上市銷售藥品的劑型，但不改變給藥途徑的制劑。已有國家藥品標準的原料藥或者制劑。中藥、天然藥物 未在國內(nèi)上市銷售的從中藥、天然藥物中提取的有效成份及其制劑。未在國內(nèi)上市銷售的來源于植物、動物、礦物等藥用物質(zhì)制成的制劑。中藥材的代用品。未在國內(nèi)上市銷售的中藥材新的藥用部位制成的制劑。未在國內(nèi)上市銷售的從中藥、天然藥物中提取的有效部位制成的制劑。未在國內(nèi)上市銷售的由中藥、天然藥物制成的復(fù)方制劑。未在國內(nèi)上市銷售的由中藥、天然藥物制成的注射劑。改變國內(nèi)已上市銷售藥品給藥途徑的制劑。改變國內(nèi)已上市銷售藥品劑型的制劑。改變國內(nèi)已上市銷售藥品工藝的制劑。1已有國家標準的中成藥和天然藥物制劑。生物制品未在國內(nèi)外上市銷售的生物制品。單克隆抗體?；蛑委?、體細胞治療及其制品。變態(tài)反應(yīng)原制品。由人的、動物的組織或者體液提取的，或者通過發(fā)酵制備的具有生物活性的多組份制品。由已上市銷售生物制品組成新的復(fù)方制品。已在國外上市銷售但尚未在國內(nèi)上市銷售的生物制品。含未經(jīng)批準菌種制備的微生態(tài)制品。與已上市銷售制品結(jié)構(gòu)不完全相同且國內(nèi)外均未上市銷售的制品（包括氨基酸位點突變、缺失，因表達系統(tǒng)
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