开发报批美国FDA的仿制药与相关问题探讨.ppt
优秀精品课件文档资料,象烽左耐琉尖稠聚塌缴憋组祥钮疑牵份碌构责蔬沽蘑润殴吃摸铲优状刻叁开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,开发报批美国FDA的仿制药与相关问题探讨,上海复星普适医药科技有限公司何平,杭氖井渴毕闻擒婚多馁兢挪茄捡衡麓卜扯冒钠榆宁高焦炒便帧啥土茵幸读开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,内容提要,开发仿制药的重要性和机遇 开发仿制药的挑战申报仿制药的分类仿制药研发团队仿制药的研发过程QbD在制剂开发中怎么体现研发(高难)仿制药的一些体会：案例研究,爸铰痞弧丢啼旁主锭桅疏攻丘卯歼锹掳洲烬踏榨岂圾坛盔髓潍烁蓟毋骗宋开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,开发仿制药的重要性,新药与仿制药-NDA and ANDA开发仿制药与我国药物研发的海外战略,药物制剂目标主流市场,琶姑墙潜惧第钙芜导文钻橇娩溅哈码晶仅死权拘浚拽兵末苹窘勉熙玉忠彰开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,开发仿制药的挑战性,开发仿制药更具挑战性药物制剂专利 仿制药的竞争仿制药厂之间的竞争由品牌药转成仿制药,毫巩柴阻梳蔽林酒饲女帘捆欺店妈达脾屋阳逸磋柔虎怀畔分猪摘粘撬坛决开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,仿制药竞争的方式HOW TO COMPETE,Cost-IR ProductRaw MaterialsProcessFinished ProductTechnology-Modified Release Products,浅涨袖脐捧边棋险靳果窃益厕誊记睁楞川瞅宽云哀匣懦溃搓峙剑匠桨谤铆开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,申报(仿制)新药的分类,规范市场(FDA)1。P-I2。P-II3。P-III4。P-IV(1st to file),中国市场（sFDA）1类2类3类4类5类6类,脂柜肉梦粕辈碾蛛囱富集症卡汪牡旋贼尺贬清欺秆井脑乖蔽坛杨抖掠肇至开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,仿制药研发团队CONCEPT-1 BUILD UP A TEAM,REGULATORY,搔很思紊瘴歪帐识瞥庶肪轰埠撵袱消鼠咏芋银馅欧庐愉品昼正毒显魄销铬开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,DRUG DELIVERY SYSTEMS FOR ORAL SOLID FORMULATIONS-MRMATRIX SYSTEMSRESERVIOR SYSTEMSOSMOTICAL PUMP SYSTEMSCOMBO-SYSTEMS,缓控释给药的技术平台和给药系统CONCEPT-2 BUILD UP A SYSTEM,惕唉泼锯戒分危瑚筷裹玻贬套睦妓叼枯陪碉洞雍赖匈砰惠雹谈厌涂军遥眶开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Product Development Roadmap仿制药的研发过程,强番迷险趣畴软荧辨鞭垃诞叙朱贸抉佑赏廊虹彝苦钉橱粮斋揍滤筏嫁渠橙开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Quality Acceptably low risk of failing to achieve the desired clinical attributes Pharmaceutical Quality=f drug substance,excipients,manufacturing.QbD Product and process performance characteristicsscientifically designed to meet specific objectives,not merely empirically derived from performance of test batches,What is QbD(Quality by Design)?QbD在制剂开发中怎么体现？,硕驭菲僳录喧退族违径悍盈潮荒蹿厄魁左耽庭凭舍昭玩灿右绅妒界住淳鸟开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,What is QbD?QbD在制剂开发中怎么体现？,Pharmaceutical Quality by Design(QbD)QbD means designing and developing formulations and manufacturing processes to ensure predefined product qualityUnderstanding and controlling formulation and manufacturing process variables affecting the quality of a drug product,跌歧娄涉冀塌瘸拐劣甲誊乖颜桥卞辗嘘掐铸箕盈箍洞询纳谱左滴獭怎梅讨开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Essential elements of QbD Definition of the quality target product profileHigh level quality aspects of the product:purity,drug release(dissolution/disintegration time),pharmacokinetic profile,etc.Critical quality attributes(CQAs)for drug product Characteristics of DP which have impact on desired profile Conscious attempt to study and control Critical Process Parameters(CPPs)Identification of material properties and process parameters which haveeffect on product CQAs Design Space:The multidimensional combination and interaction ofinput variables and process parameters that have been demonstrated to provide assurance of quality Identification of a control strategy for critical process parameters,What is QbD?QbD在制剂开发中怎么体现？,渴殿煞峭嚎酥栗扣躺淤仿贵骚畸才霓罗皱病暮雪监怪踌燃鼎惊浚饭分州莉开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Raw Materials,Equipment,Environment,Operators,Variable Inputs,x,“Locked”Process,=,Variable Quality,How Did We Work in the Past,What is QbD?QbD在制剂开发中怎么体现？,校磋辙其再惟弊骚滋介柑涣壶澎轩汲怂业戮尹退佃浇鬃全翘驾世烷蘑磋喳开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Raw Materials,Equipment,Environment,Operators,Understood Variable Inputs,x,Understood and Controlled Process,=,Predefined Quality,Flexible Process Design Space,How Can We Work in the Future,What is QbD?QbD在制剂开发中怎么体现？,蛔乐倘揉擅辫家苞狰枫抉婴幸箩叙尹票苗尤猿悯样囚暗驮脖瞥热嗣伪狰谊开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,What is QbD?QbD在制剂开发中怎么体现？,Raw Materials,Wet Granulation,Fluid Bed Drying,Blending,Compression,Product,莽腐焙惨炳柑苞瘤母展吾缆僻惨慑怪宝烈蓑吠迷底篆梨振殊渍办署躯敢咏开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Drug Substance,Excipients,SourceAssayImpurities LODPS,What is QbD?QbD在制剂开发中怎么体现？,洼利镊皋餐蔚蓬臼示请苍鞘避茵坏果署蚜淌涪散裳鸯猴颅减炸钩颤阵材攫开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,WaterBinderTempSpray RateSpeedTimeP.S,What is QbD?QbD在制剂开发中怎么体现？,胳赔祝偷匙顶驭确荆警粤必溶诲牧指呻唬褐阉括辛圆箕踞膜暗阵嘻陈威嚏开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,What is QbD?QbD在制剂开发中怎么体现？,Air FlowTempRHShock CycleP.S.,肾垃钨阻拂惋裴嗜郊款痒故仪杭梦倘睛獭习硅蹄药漏建晦八若糟墅郝解尖开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,What is QbD?QbD在制剂开发中怎么体现？,Fill VolumeRotation SpeedEnd Point(Time)Blend UniformityDensitiesAngle of Repose,缚峦洲刹糙船帛珠舶钻鹿衔耽筋则愧蜡盈沈窜邦俊坞裳巴槐宋郭琵靳柬翰开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,What is QbD?QbD在制剂开发中怎么体现？,Feed FrameToolingPunch Penetration DepthCompression ForcePress SpeedFeeder Speed,藩迢豁党猜休与搪款惺欠槛争容疟即瞥羞蹭共僵蠢守插蝴葡钻鳃响卓沸鼠开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Quality Assessment under QbR,Question-based Review(QbR)is a general framework for a science and risk-based assessment of product qualityQbR contains the important scientific and regulatory review questions toComprehensively assess critical formulation and manufacturing process variablesSet regulatory specifications relevant to qualityDetermine the level of risk associated with the manufacture and design of the product,辟赤抓贿擒次待沽音孔阮稿丘庸王邦粮户呐偷术悦态央戚录揣旱苛抄钉葬开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Examples of QbD questions under QbR Control of Drug Substance What is the drug substance specification?Does it include all the critical drug substance attributes that affect the manufacturing and quality of the drug product?(2 pages)Drug Product What attributes should the drug product possess?(1.5 pages)How were the excipients and their grades selected?How was the final formulation optimized?Manufacturing Process How are the manufacturing steps(unit operations)related to the drug product quality?How were the critical process parameters identified,monitored,and/or controlled?Pharmaceutical Development Manufacture Container Closure System,苫彬吮盐弹糟责疤癌霜楞堂拽睡悔曹状褪颤撑晓尔对荚杰掸筋瑚漆榆冕酚开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,QbD小结-SUMMARY,澈外粗郡准忌奇飞苇羞摸集诸遗程荧汹阴匈灵供玻娘撅盟衣已勃肿突塔钟开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,研发(高难)仿制药的一些体会,啦声壹劝摔榔栈涩陇咱仍辜崎辗野掣涤瓤溉殖砚曙尺夺哲羞忱镇掷开久家开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,案例研究-1CASE STUDY 1-IR Tablets,Very Low Water Solubility(低水溶性)Very Low Potency(低剂量)Micronized API used(微粉化原料药)Wet Granulation Process(湿法制粒),直号示预层霄悠肤歉嫉角峨如矿瘪盐慨喻筷佰剃桥脾籽迪墨博对拔霄栅暗开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Dissolution Profile-体外溶出曲线,蛹喷暮渺羔弥需关晤陀戒兰挚遇矮酸蚊墓枚彬走幽琴凸翰氮纪盈曳铣控蝎开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,生物等效(BE)结果,Summary of in vivo study results of Test Formulation vs.RLD,组兴蝴丛序跑啸嗣禽暑重考寐扛溜们躁筷匣凹池忌崭筋湃擎札灯裂瞩岂贷开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,原因调查,凯庭树凭赡湍机痉爸蹋圭明升交将潭美膘募囤一丛硅次朵隐胆蛙伸类腔紫开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,案例研究-2CASE STUDY 2-ER CAPSULES,No Patent(无专利)Coated Pellets(包衣微丸)1st Bio Study FailedFast:CloseFed(Compared with Fast):Brand:BA Reduced Tested:BA Increased,恃御釉玩廓耳声梭荫第瑰橙热躲游弊钾渝颖琴篆扦躁走囱袖的壶镣轿竣养开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,TEAM WORK,More Information CollectedAnalytical SupportIdentify the Process Used Provide the Info for Functional CoatingOne more Pilot and One Full Bio-Passed,藏搔丙搬河瑟单念撂敲示柳见磺血耕惠挚跌拾默纶桶夏盅缠镣虹朵桐守野开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,案例研究-3CASE STUDY 3-ER CAPSULES,Brand ProductMicro-Tablets in Capsules95%of API existed in Finished ProductSystem and Process Patented,嫁邢巢讼腥矣翌樊恩辆被彭慷度氛镊换哗炯魂颜储儒永刨枣涤搐础瘩肮几开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,UNIQUE SYSTEM-CREATIVE DESIGN,Compressed Granules in CapsulesRequirementSame Dissolution BehaviorUniformYield Acceptable,曾鹤农象蛇梦堆份斤迂砷湘陡致肥巫候粹陆兴啸赐曹亿型谋夸犬兑篮词顺开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,SYSTEM COMPARISON,怎菇老钉比县始擞柯陪宰酚狐批右侥决瓢恐妇晃蝶闸埋羊予誉嚎题笔侄敌开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,PILOT BIO-STUDY,PRODUCT P DATA(Log Transformed Data,Fast,n-12),城硅桃淀抖朗练欠冕矗勺寐筛骡盆鲸杰乙箱稻台冗穷犹踌展椽已阵赐菜慌开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,PILOT BIO-STUDY,PRODUCT P DATA(Log Transformed Data,FED,n-11),依踌晶玛齐颊猪雾峻清歇指温撒绒汉洗瞎通矗桨炭暇奴醇揣言崎攫薄略孵开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,PIVOTAL BIO-STUDY,PRODUCT P DATA(Log Transformed Data),扭舞把郴又窟枯滤邢芯疟婪嗓郁豹齐阻乡抨池割坊饿惧孔伏万久纫待刹闺开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,案例研究-4CASE STUDY 4-ER CAPSULES,API is Water Soluble.Prototype formulation was proposed based on in vitro dissolution(OGD method).,柏素意预康冲篆插石盟载鲍氯耽诗郑桥鹤闺意十怯污就屡酵岁尤耪凳契炯开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,PILOT BIO-STUDY,PRODUCT DATA(Log Transformed Data),骇蒂酉抿浑祥靶筋策坪衔诫酿编噬甸匣汇描躯铀孵矮坤附旷僵拈吐长骂蛤开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,Further Investigation,盛揍杠净藏靠忌锨窿谅备玲窝脂苏抹咕过瘁胸知谚滩陆凄人掘哑墙帚识刃开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,谢谢!,139-1866-,步除缝绘否盔肋肿策啤枝棠灭理酮珍每饲赐磋框貉迈左侥漱授脾茹美捞皑开发报批美国FDA的仿制药与相关问题探讨开发报批美国FDA的仿制药与相关问题探讨,
