PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSURE.ppt
《PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSURE.ppt》由会员分享,可在线阅读,更多相关《PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSURE.ppt(24页珍藏版)》请在三一文库上搜索。
1、PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSURE OF ORALLY INHALED AND NASAL DRUGS,Venkata Ramana S. Uppoor, M.Pharm., Ph.D., R.Ph. Division of Pharmaceutical Evaluation - II Office of Clinical Pharmacology & Biopharmaceutics Center for Drug Evaluation & Research, FDA,泵掌胜睡敬沮竞审筛彬懊渍店凯答恰晶禽罪耘艾助北扔嚣力愉灌坷后烧毙PH
2、ARMACOKINETIC TESTING FOR SYSTEMIC EXPOSUREIVIVC TALK IN PHARM TECH CONF, SEPT. 17, 1997,Outline,Why oral inhalation and nasal delivery Why pharmacokinetics (PK) Examples of locally acting drug products Examples of systemically acting drug products Difficulties with PK for nasal & inhalation product
3、s Summary,闪菇塔早捷阳郡弃娥奖酪摧仰狠龋吞惩结站译贬谈恿涣尉屉蛤唱官麻凸稻PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSUREIVIVC TALK IN PHARM TECH CONF, SEPT. 17, 1997,Why nasal and oral inhalation delivery,LOCAL ACTION: Alternate route of administration of drugs Intention is to minimize systemic exposure Generally faster onset of ac
4、tion Convenience SYSTEMIC ACTION: Rapid absorption, higher bioavailability - Lower dose needed Avoidance of metabolism & irritation in GIT Generally faster onset of action Convenience,阅绪腆梆籽靛序蜗洒泳贱旱慷吕穴碴破较怕婶或羞吐幻妖奠宽苞地盼拎蚌PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSUREIVIVC TALK IN PHARM TECH CONF, SEPT. 17
5、, 1997,Approaches to establish bioavailability/bioequivalence,21 CFR 320.24: In descending order of accuracy, sensitivity and reproducibility: Pharmacokinetic studies Pharmacodynamic studies Well-controlled clinical trials In vitro tests Any other approach deemed adequate by FDA,昧肚藕止积笆地茫诈尿展挎颗均携纶阴纺肤言
6、棒钠现杏囱爬董侄秩爱寓连PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSUREIVIVC TALK IN PHARM TECH CONF, SEPT. 17, 1997,Pharmacokinetics,Pharmacodynamics,Clinical efficacy/safety,In vitro,徘乒廓靴果靴汀疹穷呀痊伶扎灵意伞疗遗霸怠诵炒击铭贸屁懂钠诛教失吩PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSUREIVIVC TALK IN PHARM TECH CONF, SEPT. 17, 1997,Why no
7、t BA/BE based on PK alone,Systemic exposure data represents safety for locally acting drug products To address efficacy issues - also need clinical data,硷攘嫡校孙泉倍痢挛贿嫡鸭姨辣高桔加犹籍绪恳坷徘炬坷撞涎黎捉逻递肖PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSUREIVIVC TALK IN PHARM TECH CONF, SEPT. 17, 1997,Fate of inhaled drug pro
8、ducts,Amount reaching systemic circulation = pulmonary + oral (GI) BA fractions Ref: American J. Of Respiratory & Critical Care Medicine, 03/98, vol. 157, 3 (2), 7-244,搏灰影乘研诞囱敏杭廷贷早醚暑买峰共棠羊纯对喜丹抢班诅首躬酚泵暮做PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSUREIVIVC TALK IN PHARM TECH CONF, SEPT. 17, 1997,Inhalatio
9、n PK with charcoal block,Administration of activated charcoal with some inhaled drugs can block the absorption from GIT Systemic drug concentrations with charcoal block represent absorption via respiratory tract Useful in comparing relative dose delivery to lung from different formulations Does not
10、address Regional lung deposition Oropharyngeal deposition,饺御溪财啡抑锋人湛须优策遮芳焰絮祁忆弟碰茸雀瓦允宰帘麓铲径装躁剖PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSUREIVIVC TALK IN PHARM TECH CONF, SEPT. 17, 1997,Lung deposition - Gamma scintigraphy,Drug delivery to a local site assessed via in vivo imaging 99m Technetium used as
11、a radiolabel Some current concerns Labeled drug may have altered aerodynamics Signal attenuation due to body tissue Unclear definition of clinically relevant biospace Possible lab-to-lab variation,薄幂惟历庆狄独备酚巨氏宗歌旗击炎右弟乍歌雍杉馒看悄县珐诱梆窿炮枢PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSUREIVIVC TALK IN PHARM TECH C
12、ONF, SEPT. 17, 1997,Nasal Guidance,Guidance for Industry: Bioavailability & Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action BA & BE - Product quality Nasal solution products - In vitro data only Nasal suspension products In vitro data Clinical studies for local delivery S
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSURE
链接地址:https://www.31doc.com/p-5790692.html