1. 독성학 박 대 훈 한약재산업학과 dhj1221@dsu.ac.kr/dhj1221@naver.com 010-9930-5494

2. 독성학의 필요성

3. 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)

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

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

6. OECD Guidelines for the Testing of Chemicals

7. 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

8. 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

9. 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.

10. 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.

11. 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

12. 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