药品的临床试验.PPT

藥品的發展與人對健康的期待 高雅慧 成大醫學院臨床藥學研究所 藥品的臨床試驗 Randomize Double blind Controlled: Placebo or Active ingredient 人體試驗委員會 受試者同意書 Aspirin Story BC 500, Hippocrates using extracts of willow bark April 25, 1763. “An account of the success of the bark of the willow in the cure of agues” by Edward Stone. Aspirin Story 1897, Felix Hoffman Jan. 1899 “Aspirin” named by Heinrich Dreser From Aspirin to Prostaglandins 1940 Karl Link: reduced PT activity by ASA 1956 L. L. Craven: ASA in coronary and cerebral thrombosis in Mississippi Valley Medical Journal 1980 Case-control studies: Aspirin and antecedent respiratory or chickenpox illness 1971 John R. Vane proposed prostaglandins as the mediators 1988 Physicians’Health Study in NEJM The Nobel Prize in Physiology or Medicine for 2005 Milestone in Infectious Diseases 藥物的來源 植物：毛地黃、金雞納、紫杉、 日日春、古柯、罌粟、箭毒 動物：胰島素、荷爾蒙、抗毒素 礦物：碘、碳酸鹽、硝酸鹽、磷酸鹽 化學合成：????(65%) 微生物培養：抗生素、降血脂藥 基因工程：胰島素、生長激素、造血 激素 有病治病沒病強身 藥物食品檢驗局調查研究年報 藥物食品檢驗局調查研究年報 藥物食品檢驗局調查研究年報 藥物食品檢驗局調查研究年報 人對健康的期待 巫術 藝術 學術 算術 * * 藥品的研發與臨床試驗 Jan. 29, 1988 Fullads An era of “safe aspirin” or “super-aspirin”? Vioxx? withdrawal The head on the obverse of this medal is based on that of a Minoan clay figurine of a goddess from Gazi in the Archaeological Museum in Herakleion, dated 13th century BC. The representation is linked to opium both by the three poppy capsules in the diadem and by the ecstatic facial expression. 宮前町九十番地，張超英口述 臺灣醫療史，莊永明主編 .tw/taipedia/dict/welcome.aspx J. Robin Warren and Barry J. Marshall www.abdn.ac.uk/mediareleases/release.php?id=197 Thoth, Egyptian god, 305-30 BC. Sumerian prescription 2100 BC. Avicenna’s Canon Medicine 11 c. Bezoar for detoxification, c. 1600 Preparation of Guaicum for syphilis, 1570 Physician and Pharmacist in the Antidotarium 15th “My poverty, but not my will, consents” Two witness when selling poison, to guarantee no harm would result Prohibiting physicians from owning pharmacies Early 14th cen