兩岸臨床試驗利基與競爭力
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1. 法規制度、品質、效率、人才與未來發展 2. 從華人族群 基因 、特有疾病到執行國際級 臨床認驗 PowerPoint PPT Presentation


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兩岸臨床試驗利基與競爭力 ( 一 ). 1. 法規制度、品質、效率、人才與未來發展 2. 從華人族群 基因 、特有疾病到執行國際級 臨床認驗. 胡 幼 圃 特 聘 教 授 考試院考試委員 國防醫學院 / 台大醫學院 100.3.25. 內容. 1. 海峽兩岸醫藥衛生合作協議 2. 我們臨床試驗之現況 3. 華人族群基因 4. 華人特有疾病 5. 我們的利基合作進行國際級臨床試驗. 1. 海峽兩岸醫藥衛生合作協議. 海峽兩岸醫藥衛生合作協議. 第三章 醫藥品安全管理及研發 十、 合作範圍

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1. 法規制度、品質、效率、人才與未來發展 2. 從華人族群 基因 、特有疾病到執行國際級 臨床認驗

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兩岸臨床試驗利基與競爭力(一)

1.法規制度、品質、效率、人才與未來發展2.從華人族群基因、特有疾病到執行國際級 臨床認驗

胡 幼 圃 特 聘 教 授

考試院考試委員

國防醫學院/台大醫學院

100.3.25


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內容

1.海峽兩岸醫藥衛生合作協議

2.我們臨床試驗之現況

3.華人族群基因

4.華人特有疾病

5.我們的利基合作進行國際級臨床試驗


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1.海峽兩岸醫藥衛生合作協議


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海峽兩岸醫藥衛生合作協議

第三章 醫藥品安全管理及研發

十、 合作範圍

本協議所稱醫藥品,指藥品、醫療器材、健康食品(保健食品)及化粧品,不包括中藥材。

雙方同意就兩岸醫藥品的非臨床檢測、臨床試驗、上市前審查、生產管理、上市後管理等制度規範,及技術標準、檢驗技術與其他相關事項,進行交流與合作。


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十四、 臨床試驗合作

雙方同意就彼此臨床試驗的相關制度規範、執行機構及執行團隊的管理、受試者權益保障和臨床試驗計畫及試驗結果審核機制等,進行交流與合作。

在符合臨床試驗管理規範(GCP)標準下,以減少重複試驗為目標,優先以試點及專案方式,積極推動兩岸臨床試驗及醫藥品研發合作,並在此基礎上,探討逐步接受雙方執行的結果。


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2.我們臨床試驗之現況


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Domestic trial vs multi-national trial


Volume of clinical trials in asia pac ific region taiwan is a major site allocated by big pharma

Volume of Clinical Trials in Asia Pacific Region- Taiwan is a major site allocated by big pharma

Data accessed from www.clinicaltrials.gov 2009


Ranking of countries for phase ii iii industry sponsored trial sites

Ranking of countries for Phase II-III industry sponsored trial sites


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NEW IND in Taiwan (1994-2009)

Local Registration

Trial

IND New System

Bridging study

Evaluation

GCP-Taiwan

628 Announcement

SARS

CDE

established

↑Qualified Site


Distribution of ct phases

Distribution of CT Phases

(2009.1.1~9.30 IND 完成審查案件,共134件)

P: protocol S: site


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我國二十五年藥政風華

Milestone of Regulation in Taiwan

CDE

C.T.

Guidance

DSRB

GLP

ADR Center

JIRB

SRB

C.T.

Training

Registration

Trial

7.7公告

GMP

1982 1987 1993~ 1996 1998

BA/BE


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我國二十五年藥政風華

Milestone of Regulation in Taiwan

Race Disease PDT and Drug Act

藥品CGMP

Bridging study

C.T. Waiver

GCRC

醫材GMP

醫材重新分類(class)

Drug Relief

cGTP

Gene Therapy

籌備Taiwan FDA(第一次送行政院)

Non-FSC

TDRF

Consultation

window

2000 2001 2002

APEC (II)

APEC(III)

DIA 38th Annual Meeting

APEC Network project


Results of gcp inspection

Results of GCP Inspection


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3.華人族群基因


Working definition of special populations

Age

Body weight

Gender

Genotype

Organ dysfunction

Diet

Drug interactions

Food interactions

Herbal products

Smoking habit

Working Definition of Special Populations

Intrinsic Factors

Extrinsic Factors

Adapted from ICH Guideline E5: Ethnic Factors inthe Acceptability of Foreign Clinical Data, 1998


Pk pd pg for drug response

PK/PD/PG for Drug Response

NEJM 348;6, 2003


Pharmacogenetic assessment

Pharmacogenetic Assessment

  • Ultimate goal of drug development – providing safe therapies with meaningful clinical benefit

  • Most promising impact of genomics – applying biomarkers to inform therapeutic decisions

Drug – Gene Interactions  Optimal Dosing


We can and should do better finding the optimal dose

We Can and Should Do Better Finding the Optimal Dose

FDA Critical Path Document: Challenges the traditional drug development process ~ 1 in 4 approved drugs undergoes relabeling because of inadequate dosing

FDA White Paper, Challenge and Opportunity on the Critical Path to New Medical Products, 2004


Result 1 unpredictable variability in efficacy

Result #1: Unpredictable Variability in Efficacy

Spear et al. Trends in Molecular Medicine, 7:201 (2001).


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1. Assement of Phase I and II Enzyme SNPs Affect Pharmacokinetic Parameters


Summary of snps

Summary of SNPs

  • Total Single Nucleotide Polymorphisms (SNP): 96 SNPs of 8 metabolic enzymes

    • CYP2A6: 13 SNPs

    • CYP2C9: 11 SNPs

    • CYP2C19: 14 SNPs

    • CYP2D6: 25 SNPs

    • CYP2E1: 5 SNPs

    • CYP3A4: 13 SNPs

    • CYP3A5: 11 SNPs

    • UGT2B7: 4 SNPs


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2. Assess the effects of phase I and II

metabolic enzyme SNPs in drug

metabolism (PK parameters)


Acknowledgement

Acknowledgement

  • NDMC

    • 胡幼圃, Ph.D.

    • 熊正輝, Ph.D.

  • 中研院

    • 陳垣崇,所長,Ph.D.

    • 王慧虹, Ph.D.

  • Clinical trial volunteers

  • PK analysis teams

  • CRO

    -佳生、明生、世宬、昌達、美時


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4.華人特有疾病


Pk in special population fda

華人特有疾病-肝病PK in Special Population美國FDA推薦之肝功能測定新法

Galactose Single Point(GSP) method


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Guidance for Industry

Pharmacokinetics in Patients with

Impaired Hepatic Function: Study

Design, Data Analysis, and

Impact on Dosing and Labeling

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

May 2003

Clinical Pharmacology


Quantitative marker of liver residual function gsp

Quantitative Marker of Liver Residual Function - GSP

  • Galactose Single Point (GSP) status

    • US FDA Guidance

    • ROC DOH Guidance

    • Text Book

  • GSP method

  • GSP application


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肝功能不全病患的藥動學試驗基準

-臨床試驗設計、數據分析以及對劑量調整與標示的影響

GUIDANCE FOR PHARMACOKINETICS IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION: STUDY DESIGN, DATA ANALYSIS, AND IMPACT ON DOSING AND LABELING

行 政 院 衛 生 署

中華民國九十年七月


Galactose single point gsp method

Galactose Single Point (GSP) Method

  • IV infused 0.5g/kg of galactose, and measuring whole blood (collected by dry filter papers) galactose concentration enzymatically at 60 minutes later


Gsp sampling

GSP Sampling


Gsp method recent application in medical centers of r o c

GSP Method Recent Application in Medical Centers of R.O.C.

  • Diagnostic Drug: Galactose injection(干能糖,衛署藥製字第046996號)

  • Medical Centers: NTUH(台大)、TSGH(三總)、TVGH(榮總)、CGMH(長庚)、CTH(耕莘) …: 23 hospitals and clinics

  • Subjects: 766 (Chronic hepatitis: 58; Cirrhosis: 24; Hepatocellular Carcinoma: 66; Liver normal: 618)

  • The GSP values were significantly different between patients with various liver function


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Hu OYP, Tang HS and Sheeng TY, J Pharm Sci 1995;84:111-4


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兩岸華人臨床試驗之利基

1.共同族群基因-例如CYP Enzymes

2.共同特有疾病-例如肝病

3.優質卓越的臨床試驗設施,人才制度

經驗及廣大市場

4.建構兩岸臨床研究合作機制


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Thank you for your attention!


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