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20 Objectives and requirements To master a) the definition, characters, tasks and mon terms (術(shù)語 ) of pharmaceutics, b) the branch subjects (分支學科 ) of this subject, c) the classification (分類 ) of drug dosage forms,and d) the properties and characters of some drug standards (藥品標準 ) as Pharmacopoeia of the People’ s Republic of China (ChP, 中國藥典 ) and some related pharmacy regulations (藥事法規(guī) ) as Pharmaceutical Administration Law of the People’ s Republic of China (中華人民共和國藥品管理法 )and good manufacturing practice (GMP) etc. To be familiar with the progress of pharmaceutics. 21 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 。 GCP(good clinical practice):藥物臨床試驗管理規(guī)范 藥品臨床試驗:是指任何在人體(病人或健康志愿者)進行的藥品系統(tǒng)性研究,以證實或揭示實驗用藥品的作用及不良反應等。 GMP的三大要素 :人為錯誤減小到最低;防止對醫(yī)藥品的污染和低質(zhì)量醫(yī)藥品的產(chǎn)生;保證產(chǎn)品高質(zhì)量的系統(tǒng)設計。 18 GMP, GLP, GCP GMP(good manufacturing practice):藥品生產(chǎn)質(zhì)量管理規(guī)范:是在藥品生產(chǎn)過程中,用科學、合理、規(guī)范化的條件和方法來保證生產(chǎn)優(yōu)良藥品的一整套系統(tǒng)的、科學的管理規(guī)范,是藥品生產(chǎn)和管理的基本準則。 非處方藥:不需憑執(zhí)業(yè)醫(yī)師的或執(zhí)業(yè)助理醫(yī)師的處方,消費者可以