【正文】 New Drug Application)。 與編號(hào) (採(cǎi)用數(shù)字 )不同的是 ， 學(xué)名是基於藥物的化學(xué)結(jié)構(gòu) ， 如 isoproterenol有isopropyl group連在胺基酸鏈的末端氮上(terminal nitrogen)與商標(biāo)名 (brand name)不同的是 g e n e r i c n a m e 是非專利名(nonproprietary) Official Name(正式名 ) 當(dāng)試驗(yàn)藥品完全通過(guò)可做一般用途 ， 且被收錄於美國(guó)藥典 國(guó)家處方集 (United States p h a rm a co p ei a N a t i o nal Formulary)， 學(xué)名就成為正式名 ， 因?yàn)檎胶丝傻乃幤房赡苡珊芏嗨帍S以不同的名字在市場(chǎng)銷售 ， 建議臨床醫(yī)師使用無(wú)專利性的正式名 ，而非商標(biāo)名 。the United States Pharmacopeia (USP) and the National Formulary (NF) were given official status. 1914 The Harrison Narcotic Act is passed to control the importation, sale, and distribution of opium and its derivatives, as well as other narcotic analgesics. 1938 The Food, Drug, and Cosmetic Actbees law. This is the Federal Food, Drug, and Cosmetic Act to protect the pnblic health and protect physicians from irresponsible drug act is enforced by the Food and Drug Administration(FDA). 1952 The DurhamHumphrey Amendment defines the drugs that may sold by the pharmacist only on prescripition. 1962 The KefauverHarris Law is passed as an amendment to the Food, Drug, and Cosmetic Act of act requires proof of safety and efficacy of all drugs introduced since in use before that time have not been reviewed but are under study. 1963 1971 The Controlled Subsances Act bees effective。 案例： 第一級(jí)管制藥品： Morphine、 Heroin、 Opium、 Cocaine等 。Investigational New Drug)。 The prescription(處方 ) 處方係指藥物之開(kāi)立 ， 及關(guān)於調(diào)劑和服用方式之特別指示 醫(yī)師 (physician)， 整骨師 (osteopath)， 牙醫(yī)師(dentist)， 獸醫(yī) (veterinarian)可開(kāi)處方 ， 脊椎指壓治療師 (chiropractors)及驗(yàn)光師 (opticians)則不可開(kāi) 。 想要了解藥品相關(guān)的資訊可以查詢 【 MIMS臺(tái)灣藥品手冊(cè) 、 MIMS簡(jiǎn)明處方藥典 、 常用藥品手冊(cè) 】 等 ，這些收錄臺(tái)灣上市藥品的藥品資料 ， 不過(guò)內(nèi)容較為簡(jiǎn)略 。 examples: opium, morphine, certain barbiturates Schedule Ⅲ : Prescription must be rewritten after 6 months, or five refills。 二 、 影響精神藥品 。 。了解藥物的藥理作用，對(duì)臨床上藥物治療的療效，以及可能產(chǎn)生的副作用，才能充分的掌握。fasttrack B=Modest therapeutic gain C=Important options。 examples: phenobarbital, barbital, chloral hydrate, meprobamate (Equanil, Miltown), and zolpidem (Ambin) Schedule Ⅴ : As for any nonopioid prescription drug。 examples: narcotics contanining nonnarcotics in mixture form, such as cough preparations or Lomotil (diphenoxylate, narcotic with mg and atropine sulfate,nonnarcotic). Rau’ s Respiratory Care Pharmacology. 7th edition, 2023, Mosby 1906 國(guó)會(huì)通過(guò)第一個(gè)藥物食品法 。 little or no therapeutic gain Orphan Drugs (孤兒藥 ) 治療罕見(jiàn)疾病之藥 罕見(jiàn)： (.) a. 少於二十萬(wàn)人或發(fā)生率 萬(wàn)分之五 萬(wàn)分之五，但不預(yù) 期可回收藥物開(kāi)發(fā)之成本 Examples of orphan drugs of interest to respiratory care clinicians showing either a proposed use or an approved use*by the food and Drug Administration DRUG Acetylcysteine α 1 Proteinase inhibitor (Prolastin)* Beractant (Survanta)* Colfosceril palmitate(Exosurf Neonatal)* Cystic fibrosis transmembrane conductance regulator Dornase alfa(Pulmozyme)* Nitric oxide (INOmax) Tobramycin by inhalation (TOBI)* PROPOSED USE IV for moderate to severe acetaminophen overdose Replacement therapy in the α 1 proteinase inhibitor congenital defect Prevention or treatment of RDS in the newborn Prevention or treatment of RDS in the newborn Treatment of cystic fibrosis Reduce mucus viscosity and increase airway secretion clearance in cystic fibrosis Treatment of persistent pulmonary hypertension of the newborn, or acute respiratory distress in adults Treatment of Pseudomonas aeruginosa in cystic in cystic fibrosis or bronchiectasis 臺(tái)灣新藥研究發(fā)展與核準(zhǔn)上市過(guò)程 (與美國(guó)差不多 ) ，汰選找出具有發(fā)展?jié)摿χ禄瘜W(xué)物質(zhì) (NEC。 Thank You For Your Attention！ 謝謝觀看 /歡迎下載 BY FAITH I MEAN A VISION OF GOOD ONE CHERISHES AND THE ENTHUSIASM THAT PUSHES ONE TO SEEK ITS FULFILLMENT REGARDLESS OF OBSTACLES. BY FAITH I BY FAITH 。 ，包括動(dòng)物體內(nèi)及動(dòng)物體外試驗(yàn)。分為五等級(jí)，級(jí)數(shù)越高，其濫用之 可能性越低，醫(yī)療用途越高及成癮性越低 美國(guó)藥物管理之發(fā)展 第一級(jí) (scheduleⅠ ): 非研究用途皆為非法，如 heroin, marijuana, LSD, peyotemescaline 第二級(jí) (scheduleⅡ ): 不得以電話處方，非經(jīng)診察不得單純領(lǐng)藥 (refill)，如 :opium, morphine, certain barbituates, amphetamines 第三級(jí) (scheduleⅢ ): 處方在 6個(gè)月後需重新開(kāi)立，或只可單純領(lǐng)藥五