循证医学与药物流行病学原则在美国FDA药物风险评估中应用.pptVIP

Drug Risk Assessment in US FDA – Applying the Principles of Evidence-Based Medicine and Pharmacoepidemiology循证医学与药物流行病学原则在美国FDA药物风险评估中的应用;Disclosure and Disclaimer (告知);Focus of the Presentation (报告的重点);Drug Risk Assessment – A New Focus in China药物风险评估 - 中国的一个的新趋势;US FDA Risk Assessment/Management Guidance美国FDA风险评估及管理方面的指导原则;What is Drug Risk Assessment ？何为风险评估 ？ ;Drug Risk Assessment - Three Key Questions药物风险评估的三个中心问题;What is Key Concern Here ?关注点何在 ？;A clinician’s perspective that leads to AE reporting, and a real question should be……. (这只是从临床学家的角度看问题) ;Which addresses causality from a public health perspective (这是从公共卫生的角度看问题) ;This is NOT an Easy Question Because…….这不是一个容易的问题， 因为……;Four million births in the U.S. every year Sudden Infant Death Syndrome (SIDS) occurs (during the first year of life) at a rate of about 1/1500 in the U.S. Each year, 50-100 children can be expected to die by chance in any two-day period 美国每年有4百万新生儿，新生儿悴死症的发病1/1500。因此，每两天就会有50-100新生儿悴死症病例 ;Here Comes Phamacoepidemiology由此引进了药物流行病学;Take Home Message #1要点一：;Population-Based Approach 群体思维方法的三要素;The Role of Numerator, Denominator and Control (分子,分母和对照的意义);What is Evidence-Based Medicine ?对循证医学的误解;Take Home Message #2要点二：;Type of Evidence being Used…….对不同证据的运用;The Challenge - Strength of Evidence证据可信度的挑战;How Strong is the Evidence 证据的可信度;This is an approach focusing on…….这种思维方法强调 .. .. ;This is an approach NOT focusing on…….这种思维方法不强调 .. .. ;Drug Risk Assessment - Three Key Questions药物风险评估的三个中心问题;What is Key Concern Here ?关注点何在 ？;The Basic Assumption for Using Frequency is…....用百分比来表示危险程度时….... ;What Will Happen if…….但如果 ……. ;Let’s Average Them Out – Person-Time Approach采用人年方法 ;Frequency vs. Person-Time百分比与人年方法比较;The Basic Assumption for This Calculation is…....采用人年方法的假设是.... ;Life-Table Approach - Focus on Each Interval寿命表法 - 关注每个区间 ;Drug Risk Assessment - Three Key Questions药物风险评估的三个中心问题;Summary: Three Key Questions in Risk Assessment总结：药物风险评估的三个中心问题;Topics t