독성학 박 대 훈 한약재산업학과 010-9930-5494.

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Presentation transcript:

독성학 박 대 훈 한약재산업학과

독성학의 필요성

Thalidomide Tragedy The Shadow of Thalidomide, U.S. & Politics – Retro Report (12:02) BBC1, 2002, Thalidomide Life at 40 (49:18) Thalidomide Facts (03:02) 지식채널 e: 동물실험 ( 탈리도마이드 베이비 )(05:23) YTN, 2013, 탈리도마이드 사건 뉴스 MBC News, 2005, 탈리도마이드 혈액암 특효약 (01:23)

What A Wonderful World! What a wonderful world with David Attenborough – BBC One (02:00)

Drug Discovery and Development From PhRMA, 2007, Drug Discovery and Development

OECD Guidelines for the Testing of Chemicals

The Discovery Process From PhRMA, 2007, Drug Discovery and Development Pre-discovery  Understand the disease Target Identification  Choose a molecule to target with a drug Target Validation  Test the target and confirm its role in the disease

The Discovery Process From PhRMA, 2007, Drug Discovery and Development Drug Discovery  Find a promising molecule ( a “lead compound”) that could become a drug There are a few ways to find a lead compound: - Nature - De novo - High-Throughput Screening - Biotechnology

The Discovery Process From PhRMA, 2007, Drug Discovery and Development Early Safety Tests  Perform initial tests on promising compounds Successful drugs must be: - absorbed into the bloodstream, - distributed to the proper site on action in the body, - metabolized efficiently and effectively, - successfully excreted from the body and - demonstrated to be not toxic.

1. Drug Discovery & Development The Discovery Process From PhRMA, 2007, Drug Discovery and Development Lead Optimization  Alter the structure of lead candidates to improve properties Non-clinical Testing  Lab and animal testing to determine if the drug is safe enough for human testing Based on the drug’s clinical applications several toxicological studies need : - genetic toxicity test, - single- / repeated toxicity test, - immune toxicity test, - reproductive toxicity test, - carcinogenesis test, etc.

1. Drug Discovery & Development The Development Process From PhRMA, 2007, Drug Discovery and Development Investigational New Drug (IND) Application and Safety  File IND with the FDA before clinical testing can begin; ensure safety for clinical trial volunteers through an institutional Review Board Phase I Clinical Trial  Perform initial human testing in a small group of healthy volunteers Phase II Clinical Trial  Test in a small group of patients Phase III Clinical Trial  Test in a large group of patient to show safety and efficacy

The Development Process From PhRMA, 2007, Drug Discovery and Development New Drug Application (NDA) and Approval  Submit application for approval to FDA Manufacturing Ongoing Studies and Phase IV Trials