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暄司董
5 years ago
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1 更令類料更切料量療理類料理理理六度來療療 1

2 年理量六列年領量量列列 USPDI 理 ( FDA) Approved Prescription Drug Product With Therapeutic Equivalence EvaluationsOrange Book 數 FDA 聯聯 European Union The European Agency for the Evaluation of Medicinal Products EMEA 2

3 更列理利利 EMEA 列年 Physicians' Desk ReferencePDR British National FormularyB.N.F. Data Sheet and Summary of Product Characteristics Compendium published by Association of British Pharmaceutical Industries,ABPI Drugs in Japan Arzneimittel-Kompendium der Schweiz Compendium of Pharmaceuticals and Specialities 六 Dictionnarie ViDal MIM'S 3

4 Rote Liste 利 Repertoire Commente Des Medicaments Farmacevtiska specialiteter i Sverige FASS 年列年數列 USP USPDI Extra Pharmacopoeia 參更理更料糖不糖列說理不療臨料列六 FDA Orange book USPDI 行量量料料料料料料 4

5 料數年 Primary Standard Working Standard Primary Standard 來 Working Standard 來量力料料料六料數數年數類量不錄數列錄 () 數量 5

6 () () 量量 () Primary Standard Working Standard Primary Standard 來 Working Standard 來量力 () 數錄 ( 六 ) 錄 () () () 錄行不行錄錄不錄良錄料量更利列 6

7 利理料理料力料率臨料不料料料列不不不不不聯不數不六不年不不不不不不列欄列數量糖不量 7

8 欄量量理量糖零不量量量暈不量六理欄欄料量欄列量量率不列量量料量量量六療不量料料量 8

9 類欄料類參療料切切切切切列易識類列 () 量 () 類 () 良行良 GMP 良 9

10 流行不行量列 () () 不 () 類列六列量 () 見 () 冷冷 () 狀不理理不異不行不不參不 10

11 度不度類類不六量不理料狀更不更不六列 () () 不列 () () () 年易識料類療 11

12 理例令理料更行行連良 () 年領年六料料不令不不 () 年六領年料不理 () 年六領年料不理 12

13 () 年年不不不行切料料不不行料料 () 行更行臨料行臨良臨臨理行臨臨臨臨行見行臨更不臨料不料料臨料更六六六料類 13

14 行理領理列類更 GMP 料 GMP GMP 料列不不不不良料不不不療不量六不 Caffeine 類類類暈療類類量 8%W/V 糖糖量 W/V 糖量列 14

15 量不列 () 量糖糖 ( ) Ephedrine Hydrochloride dl-methylephedrine Hydrochloride 量 () 量量料不理領料不不六更不令不六料不理料領理領列理領 15

16 六料領理領料更更更領更更更領理料不不列料行數量量列理料理臨留料行不行不臨料 16

17 領理不理領數量列理料不不立數量數量量行料理例行行理列更數量領療列列理列臨料復不列臨料列不列臨料更臨料不料復領 17

18 不列復料復料復不良量療理療理說理料料錄力年六列度量不不量度不不不 18

19 糖粒粒六行行行料數錄留行不行行率行率理行率率率離率料領領列行 19

20 列行 () 行臨臨 () 立 GMP () GMP () 立列行臨臨 Bridging Study () 立 GMP GMP () 立療不行領量量料量量料料六料料料臨 20

21 量切料領料料留更更行行料更論更更行六更料料數留更行年行行歷年料數料留更更料料留料不六更行率更料 21

22 () () 離率更料 () 料來 () 離率料 () 料不更更料來離率更更理六率連臨行率率行行更率量不不不量更更不理料更列行更更良錄留令理更 22

23 () 更不 () 數量不例更 () 更不 () 識 CIS 更 () ( 六 ) 不量不更不 () 更識 GMP GMP 利 () 更 () 更更連 () 更不 () 更 ( 六 ) 列 () 不句 () 更 () 更 () 不 23

24 更領列列類理理更列料更更切更更更類更列料更臨更更類料更糖更量更更列料更錄 24

25 料切六料更更列料更錄料切六料更量不更更列更理列類類類量力更列不更理不量 25

26 不不更列料更臨六更行臨料療量量料行料行行臨量更列料更量臨 26

27 六量更六更列料更更料料料更行更六理量不理料狀更不更料不更列料更更說異更更列料更 27

28 六更錄量更量不不更料更量更量料六更不利更列料更更更更立不理更列理更利更更更更 28

29 切切六更更更行更更六更不列料更更更更更六更列更更列料 () 更 () () 更 () 更 29

30 更列料 () 更 () () 更良 () 更良料不更列料 () 更 () () () 更六更列料更更更切六更六 30

31 列料契說理更類六說料不不良更行料不更列料料切行更 31

32 六列料更切 () 六更錄 GMP 良六六列料契列行六更列料更更更切六更更 32

33 說異六更列料更理料更六流行更列料更更料更更臨料六更更理列料更量切切列料 33

34 () () 量 () 切 () 更 () 不不六理列料 () () () 理理理更行率理列料更切六 34

35 不理六理更欄列料契六量料料料數行 35

36 列不不金拾不列參參六不茶葉茶葉量參數六列不不 36

37 不不六不不聯濫療臨療不數不不不聯不不不不不不更欄數量數量量粒粒露量不行更量 37

38 療更不料量欄列料料量料量量料量量粒料量量露料量量量料量量量欄列臨臨量欄列量量例量量 38

39 量量量量量量年不量列易識不理不異不六不不參不度不度不不列 39

40 類類列 () () () 年易識類六良行 GMP 良流行不行料領領列理領 40

41 理領料更更更領領更更理更領理料不不列料數量量數量數量量行更數量料不理 41

42 料六糖不不糖不量例參料例數參例數不量料理臨易錄列類來切切切切切更行臨料行臨良臨理行臨臨臨臨料 42

43 行見行臨行更更更不錄更料欄六六不良列料切切六錄錄 43

44 行不料列料切六錄料料列 () 料料 () () 料料列 () () 料料料料 44

45 行不料料臨料不量六六說理料料錄力不數更更更更列料更 GMP 更切更更六更更切 45

46 更更粒粒更更更列料更切六錄錄更更列料更錄六錄 46

47 更更零更更類例更更理零量更列料更更量更更理六更理零類更列料更六更更理零更列行更更良錄留令理更 47

48 () 更不 () 數量不例更 () 更不 () 識 CIS 更 () 更不 () 更識 GMP GMP 料利 () 更 () 更更連 () 更不 () 更 ( 六 ) 列 () 不句 () 更 () 更 () 不更零更行更更列更 48

49 不更更量列料 () 更 () 更不列料 () 更 () () () 錄更更列料更更零六切六六六料六料留六六零更更更更更六六零留 49

50 零理更列料欄列料 () 更 () () () () 理料六年行不年良行 50

51 量量量料量量料料粒 Liposome 料六料料料料料料料量料 51

52 量類量不 Vial or Ampoule 不不粒料不糖料不不 1. 欄數量量更 2. 量行更量療更 3. 量 4. 不易 5. 量不量量 6. 量 7. 量 52

53 8. 欄領 9. 量 10. 料零量粒量 11. 量 53

54 量量料料切 * ** 良療量量量量錄料料 *** 料料料不料 * GMP ** 行量量料 *** 料 54

55 量量料理刺理理 / 率臨 Liposome Liposome 療 Liposome Liposome ( ) ( ) Liposome 量量 Liposome 量量 Liposome 料不料理 12 率臨療料臨理量率臨料臨行臨 55

56 料料 ( ) 切切錄料量錄料良料料臨率料不料臨 12 率臨行 1 2 率臨料列類料量料契 56

57 粒 (Liposome) 料 Liposome 理刺理理 / 臨 (i) (ii) 料不料理 (1)(2) 率臨 (i) 例不 (ii) 例療料臨理率臨 57

58 六料料類類切切錄 ()( ) () 良料料料料來料來來料料不類類 () 利 () 類 ( 來 ) () 利 () 類 ( 來 ) 領 () 利 () 類 ( 來 ) 領 () 利 () 類 ( 來 ) 領行 () 料 58

59 料理臨理量六量量刺率理率臨臨料類類料不料 1MCB(Master Cell Bank) MWCB(Manufacture Working Cell Bank) 2 類 (Seed Lot System) (seed strain)master Seed Lot, Manufacturing Working Cell Bank(MWCB)(Cell Culture Medium)() 3 料來料 ( 類 ) 料 (Plasma pool)(nucleic acid amplification technology;nat) HCVHIV HBV NAT 若 NAT 靈度類料參料 59

60 料料料料料切 () 切 () () () 1 料 * 2 * 2 * 3 * 3 料不料 *1 參見料料 *2 料數料 *3 () 數量量錄 ( 料 ) 料 GMP GMP 料 60

61 料料料料料料料錄料 * 料 * 領 40 料料留 61

62 料量切料 * ** 良 **** 錄料料 *** 料料料不料 * GMP ** 行量料 *** 料 **** 臨 12 率臨 62

63 量料臨類理臨 ( ) 輻量料 / 類理量度離料量量刺輻理率臨療料量料量料不料料 63

藥品查驗登記審查準則

藥品查驗登記審查準則 1 USPDI 2 ( FDA) Approved Prescription Drug Product With Therapeutic Equivalence EvaluationsOrange Book FDA European Union The European Agency for the Evaluation of Medicinal Products EMEA EMEA 3 Physicians'