1024-5c台湾临床现状及临床机构遴选.pdf

台湾地区临床现状及 临床机构遴选 邱怡君 臨床研究處 資深處長 昌達生化科技股份有限公司 1 名詞差異 Bioequivalence 生體相等性 生物等效性 Ph ki ti 藥動 藥代armaco ne cs Innovator 原廠藥/新藥 原研 Generic 學名藥 仿製藥 Reference?Drug 對照藥品 參比製劑 Test?Drug 受試藥品 受試製劑 confidential 2 Two?Kinds?of?Drugs Brand?New?Drugs?(Reference) Innovator?drug Price?of?new?medicine Generic?drugs Identical?or?bioequivalent?to?a?brand?name?drug?in? dosage?form,?safety,?strength,?route?of? administration,?quality?and?intended?use Safe?and?effective?alternatives?to?brand?name? prescriptions Can?help?both?consumers?and?the?government? reduce?the?cost?of?prescription?drugs confidential 3 NDA?vs.?ANDA?Review?Process Original?Drug NDA Req irements Generic?Drug ANDA Requirements? u 1. Chemistry 2 Manufacturing ? 1. Chemistry 2 Manufacturing. 3. Controls 4 Labeling . 3. Controls 4. Labeling. 5. Testing 6. Animal?Studies 5. Testing 7. Clinical?Studies (phases?I,?II,?III) 6. Bioequivalence?Study?(In? vivo,?In?vitro)? [Note] Generic?drug?applications?are?termed?abbreviated?because?they?are?generally?not?required? to?include?preclinical?(animal)?and?clinical?(human)?data?to?establish?safety?and?effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., confidential 4 ? ? ? ? ? ? ? ? ? ? ? ? performs?in?the?same?manner?as?the?original?drug). General?Concepts Bioavailability?(BA):?Indicates?of?a?measurement?of?rate?? extent of therapeutically active drug that is delivered from? ? ? ? ? ? ? ? ? pharmaceutical?form?and?reaches?the?systemic?circulation? and?is?available?at?the?site?of?action?(Tmax,?Cmax,?AUC). Bioequivalence?(BE):?“the?absence?of?a?significant? difference?in?the?rate?and?extent?to?which?the?active? ingredient?or?active?moiety?in?pharmaceutical?equivalents? or?pharmaceutical?alternatives?becomes?available?at?the? site of drug action when administrated at the same molar? ? ? ? ? ? ? ? ? ? dose?under?similar?conditions?in?an?appropriately? designed?study…”?(21?CFR?§320.1). Simply,?we?can?define?bioequivalence