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' 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 Dictionnarie ViDal MIM'S Rote Liste Repertoire Commente Des Medicaments Farmacevtiska specialiteter i Sverige FASS USP USPDI Extra Pharmacopoeia 4
FDA Orange book USPDI Primary Standard Working Standard Primary Standard Working Standard 5
() () () () Primary Standard Working Standard Primary Standard Working Standard 6
() () () () () 7
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9
() () 10
() GMP () () () () () () 11
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() () () () () 13
() () () () 14
() 15
GMP GMP GMP Caffeine 16
8%W/V W/V () () Ephedrine Hydrochloridedl-Methylephedrine Hydrochloride () 17
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() () GMP () GMP () Bridging Study () GMP GMP () 23
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() () () () () 25
() () () () CIS () () 26
() GMP GMP () () () () () () () () () 27
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33
() () () () () () () () () () () () 34
35
() GMP 36
37
() () () () () 38
() () () 39
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43
44
() () 45
() GMP 46
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() () () 50
() () 51
GMP 52
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() () () () CIS () 54
() GMP GMP () () () () () () () () () () () () 55
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() () () () () 57
Liposome 58
Vial or Ampoule 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 59
** * *** * ** 60
/ Liposome Liposome Liposome Liposome Liposome Liposome Liposome 61
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63 Liposome / Liposome (i) (ii) (i) (ii)
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1 MCB(Master Cell Bank) MWCB(Manufacture Working Cell Bank) 2 (Seed Lot System) (seed strain)master Seed Lot, Manufacturing Working Cell Bank(MWCB) (Cell Culture Medium) ( ) 3 ( ) (Plasma pool) (Nucleic acid amplification technology;nat) HCVHIV HBV NAT NAT 65
() ( ) ( ) 1 * 2 * 2 * 3 * 3 *1 *2 *3 ( ) ( ) GMP GMP 66
* * 40 67
** *** **** ** * *** **** * GMP 1 2 68
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