ASSESSMENT OF DRUG EFFECTS 药物作用评价 Qing-tong Wang(汪庆童) hfwqt727@163.com Institute of Clinical Pharmacology (临床药理研究所) 1
ASSESSMENT OF DRUG EFFECTS 药物作用评价 1 Institute of Clinical Pharmacology （临床药理研究所 ） Qing-tong Wang （汪庆童 ） hfwqt727@163.com
Physiological and Laboratory Markers of Drug Effect Dose-effect and Concentration-effect Analysis Therapeutic Drug Monitoring (TDM) 2
☼ Physiological and Laboratory Markers of Drug Effect ☼ Dose-effect and Concentration-effect Analysis 2 ☼ Dose-effect and Concentration-effect Analysis ☼ Therapeutic Drug Monitoring (TDM)
PHYSIOLOGICAL AND LABORATORY MARKERS OF DRUG EFFECT 3
PHYSIOLOGICAL AND LABORATORY 3 MARKERS OF DRUG EFFECT
STROKE 4
4 STROKE
THERAPEUTIC BIOMARKER/ CLINICAL CLASS SURROGATE OUTCOME Anti-hypertensive b.p. stroke Antibiotics Neg.culture Clinical cure Checing blood pressure .: 5
THERAPEUTIC BIOMARKER/ CLINICAL CLASS SURROGATE OUTCOME b.p. stroke Antibiotics Anti-hypertensive Neg. culture Clinical cure 5
BIOMARKER "A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes,or pharmacologic responses to a therapeutic intervention" BIOMARKERS DEFINITIONS WORKING GROUP: BIOMARKERS AND SURROGATE ENDPOINTS:PREFERRED DEFINITIONS AND CONCEPTUAL FRAMEWORK. CLIN PHARMACOL THER 2001:69:89-95. 6
BIOMARKER “A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to 6 a therapeutic intervention” BIOMARKERS DEFINITIONS WORKING GROUP: BIOMARKERS AND SURROGATE ENDPOINTS: PREFERRED DEFINITIONS AND CONCEPTUAL FRAMEWORK. CLIN PHARMACOL THER 2001;69:89-95. 6
A ALAVA CHARAK SUSHRUT 7
7
USES OF BIOMARKERS predict disease more precise diagnoses more effective,individualized treatments take preventive measures avoid unnecessary treatments 8
USES OF BIOMARKERS predict disease more effective, individualized treatments 8 take preventive measures avoid unnecessary treatments
DOES TERMINOLOGY MATTER? At least some of the controversy in this area results from confusion in the interchangeable use of the terms: Biomarker Clinical Endpoint Surrogate Endpoint 9
DOES TERMINOLOGY MATTER? At least some of the controversy in this area results from confusion in the interchangeable use of the terms: @ Biomarker 9 @ Clinical Endpoint @ Surrogate Endpoint 9
CLINICAL ENDPOINTS Clinical Endpoint:A clinically meaningful measure of how a patient feels,functions or survives.Clinical endpoints are usually acceptable as evidence of efficacy for regulatory purposes. Intermediate Endpoint:A clinical endpoint that is not the ultimate outcome but is the real clinical benefit. Ultimate Outcome:A clinical endpoint such as survival,onset of serious morbidity or symptomatic response that captures the benefits and risks of an intervention. 10
CLINICAL ENDPOINTS Clinical Endpoint: A clinically meaningful measure of how a patient feels, functions or survives. Clinical endpoints are usually acceptable as evidence of efficacy for regulatory purposes. 10 Intermediate Endpoint: A clinical endpoint that is not the ultimate outcome but is the real clinical benefit. Ultimate Outcome: A clinical endpoint such as survival, onset of serious morbidity or symptomatic response that captures the benefits and risks of an intervention. 10