本書系統(tǒng)介紹了生物制劑領(lǐng)域的基礎(chǔ)專業(yè)知識,包括生物制劑的定義、產(chǎn)品技術(shù)、生產(chǎn)工藝、生物技術(shù)、產(chǎn)品形式及包裝、新藥申請介紹、藥品制造規(guī)范等內(nèi)容,同時具體介紹了生物制藥研發(fā)的具體流程。本書的選文反映了生物制藥專業(yè)英語的特點和表達(dá)方式,適應(yīng)醫(yī)藥領(lǐng)域教學(xué)的需求,可作為各高校醫(yī)藥相關(guān)專業(yè)參考教材。
馬超,韓語博士,貴陽理工學(xué)院制藥工程學(xué)院副教授;劉麗萍,生物工程醫(yī)學(xué)博士,貴陽理工學(xué)院制藥工程學(xué)院副教授。
Unit 1 What is Biopharmacetical?
Unit 2 Biopharmaceutical production technology
Unit 3 Production in Pharmaceutical Biotechnology
Unit 4 the forms of biopharmaceutical product
Unit 5 Labeling and Packaging
Unit 6 Package Insert
Unit 7 New Drug Application (NDA)
Unit 8 Good Manufacturing Practice for Drugs
Unit 9 Mechanism of asthma
Unit 10 Preparation of Protein
Unit 1 What is Biopharmacetical?
Unit 2 Biopharmaceutical production technology
Unit 3 Production in Pharmaceutical Biotechnology
Unit 4 the forms of biopharmaceutical product
Unit 5 Labeling and Packaging
Unit 6 Package Insert
Unit 7 New Drug Application (NDA)
Unit 8 Good Manufacturing Practice for Drugs
Unit 9 Mechanism of asthma
Unit 10 Preparation of Protein