安徽医科大学：《临床药理学 Clinical Pharmacology》课程教学资源（课件讲稿，英文版）药物作用评价 Assessment of drug effects（主讲：汪庆童）

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