'Bridging study' diaporamas de présentation

Bridging study - PowerPoint PPT Presentation

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??????????????. ??? ????????. Bridging. Climate Medical Practice Culture Regulatory practice GCP Drug-drug interaction. Extrinsic factors Intrinsic factors. Genetic. Gender. Race. Renal Disease. Hepatic Disease. Age. Which way ?. ???????. ICH E5

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640 views • 42 slides
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??????????????. ??? ????????. Bridging. Climate Medical Practice Culture Regulatory practice GCP Drug-drug interaction. Extrinsic factors Intrinsic factors. Genetic. Gender. Race. Renal Disease. Hepatic Disease. Age. Which way ?. ???????. ICH E5

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423 views • 42 slides
Several Years Experience on Bridging Studies and the Future

Several Years Experience on Bridging Studies and the Future

Several Years Experience on Bridging Studies and the Future. National Cancer Center Hospital Head, Breast and Medical Oncology Group Yasuhiro Fujiwara MD, PhD. Drugs Approved with a Prospectively Conceptualized Bridging Strategy during Clinical Development. As of September 30, 2002

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562 views • 38 slides
A Case Study in the Value of Harmonisation

A Case Study in the Value of Harmonisation

A Case Study in the Value of Harmonisation. Yoshikazu HAYASHI Deputy Director Evaluation and Licensing Division Pharmaceutical & Food Safety Bureau Ministry of Health, Labour and Welfare, JAPAN. Philosophy/Purpose of ICH.

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389 views • 25 slides
A Bayesian Non-Inferiority Approach to Evaluation of Bridging Studies Chin-Fu Hsiao, Jen-Pei Liu

A Bayesian Non-Inferiority Approach to Evaluation of Bridging Studies Chin-Fu Hsiao, Jen-Pei Liu

A Bayesian Non-Inferiority Approach to Evaluation of Bridging Studies Chin-Fu Hsiao, Jen-Pei Liu Division of Biostatistics and Bioinformatics National Health Research Institites Huey-Miin Hsueh Department of Statistics National Cheng-Chi University

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394 views • 17 slides
Clinical Development Process in ICH E5 Environment (1)

Clinical Development Process in ICH E5 Environment (1)

Clinical Development Process in ICH E5 Environment (1). Current status ; Classical bridging Bridging study in PIIb (DFS) Aiming skipping PIII Most efficient in legacy products Only acceptable on prospective planning Need to reduce the initial GAP for simultaneous filing.

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169 views • 3 slides

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