www.wunan.com.

tw
(02)2705-5066

www.wunan.com.tw
(02)2705-5066

1813511
161718

www.wunan.com.tw
(02)2705-5066

INDEX

1
1-1
1-2
1-3
1-4
1-5
1-6
1-7
1-8
1-9
1-10
1-11
1-12
1-13
1-14
1-15

002
004
006
008
010
012
014
016
018
020
022
024
026
028
030

2
2-1
2-2
2-3
2-4
2-5
2-6
2-7
2-8

034
036
038
040
042
044
046
048

3
3-1
3-2
3-3
3-4
3-5
3-6
3-7

052
054
056
058
060
062
064
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4
4-1
4-2
4-3
4-4
4-5
4-6
4-7
4-8
4-9
4-10
4-11
4-12
4-13
4-14
4-15
4-16
4-17
4-18
4-19

068
070
072
074
076
078
080
082
084
086
088
090
092
094
096
098
100
102
104

5
5-1
5-2
5-3
5-4
5-5
5-6
5-7
5-8
5-9
5-10

108
110
112
114
118
118
120
122
124
126

6
6-1
6-2

132

130

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INDEX

6-3
6-4

7
7-1
7-2
7-3
7-4

150
152
154
156
158

164
166
168
170
172
174
176
178
180

9
9-1
9-2
9-3
9-4
9-5
9-6
9-7

140
142
144
146

8-1
8-2
8-3
8-4
8-5
8-6
8-7
8-8
8-9
8-10
8-11
8-12
8-13
8-14
8-15
8-16

134
136

160
162

184
186
188
190
192
194
196
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9-8
9-9
9-10

10
10-1
10-2
10-3
10-4
10-5
10-6
10-7
10-8
10-9
10-10

246

13
13-1
13-2

228
230
232
234
236
238
240
242

12
12-1
12-2
12-3

206
208
210
212
214
216
218
220
222
224

11
11-1
11-2
11-3
11-4
11-5
11-6
11-7
11-8

198
200
202

248
250

254
256

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INDEX

13-3

14
14-1
14-2
14-3

286
288

292
294

18
18-1
18-2
18-3
18-4
18-5
18-6
18-7

278
280
282

17
17-1
17-2
17-3
17-4
17-5

270
X 272
274

16
16-1
16-2
16-3

262
264
266

15
15-1
15-2
15-3

258

290

300
302
304
306
308
310
312

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www.wunan.com.tw
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www.wunan.com.tw
(02)2705-5066

1-1
1-2
1-3
1-4
1-5
1-6
1-7
1-8
1-9
1-10
1-11
1-12
1-13
1-14
1-15

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1-1

drugs

Pharmacology
Pharmacodynamics
Pharmacokinetics

1.

2. 460377
DioscoridesDe materia
Medica 500
Calen 130200
80

3. 315

Aricennna 5

4. 18
19
Oswald
Schmeiderberg

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460377

[CAN STOCK]

Pharmacodynamics

Molecular Pharmacology
Chemical Pharmacology

Pharmacokinetics
Pharmacotherapeutics
Toxicology
Pharmacogenetics

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1-2

botulinum toxin
1 5,000

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acetylcholine

Paracelsus 15

[CAN STOCK
]

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1-3

1.

2.

3.
(1)

digitoxindigoxinmorphine
quinine
(2)

4. MgO NaHCO3

1.

2.

3.

4.

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NCH3

OH
CH3O
O
codeine

NCH3

HO

NCH3

OH
O
morphine

CH3COO
OCOCH3
O
heroin

aspirin

O
R=

NH

CH2

G penicillin G

H3C

H3C
HOOC CH

CH
N

CH

R=

NH

OH

NH2
amoxicillin

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1-4

4 659
788
40

1. The Chinese PharmacopeiaCh.P. 1949

1980 1995 2000
2006 2011
2. P.R.O.C Pharmacopeia 1953

3. The United States PharmacopeiaU.S.P.

1820 1950 5
4. British PharmacopeiaB.P.1864 5
1999
CAS

5. The Japanese PharmacopeiaJ.P.

6. European PharmacopeiaE.P. 1964

1977

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European Pharmacopeia

harmonizationEP.
USP JP
EP

USP

JP

2.6.12 Microbial Examination of <61> Microbial Examination of

Nonsterile Products: Microbial Nonsterile Products: Microbial
Enumeration Tests
Enumeration Tests

35.1 Microbial Examination of

Nonsterile Products: Microbial
Enumeration Tests

2.6.13 Microbial Examination of <62> Microbial Examination of

Nonsterile Products: Tests for
Nonsterile Products: Tests for
Specified Microorganisms
Specified Microorganisms

35.2 Microbial Examination of

Nonsterile Products: Tests for
Specified Microorganisms

5.1.4 Microbiological Quality

of Nonsterile Pharmaceutical
Preparations and Substances
for Pharmaceutical Use

<1111> Microbiological
Examination of Nonsterile
Products: Acceptance
Criteria for Pharmaceutical
Preparations and Substances
for Pharmaceutical Use

7 Microbiological Examination
of Nonsterile Products:
Acceptance Criteria for
Pharmaceutical Preparations
and Substances for
Pharmaceutical Use

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1-5

1. code name
RU 486RU Roussel-Uclaf
mifepristone
2. nonproprietary namegeneral name

3. generic nameofficial name

4. chemical name

5. proprietary namebrand name

acetaminophenacetaminophen N-acetyl-Paminophenol Tylenol

Panadol

generic drugs

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10

11

brand name
30 SUPERSTAT TABLETS 10mg
[Simvastatin]

$00.00

Take ONE tablot at night.

Avoid eating grapefruit or drinking grapefruit juice.

active ingredient

Mr A. Contos
Full cost
Dr D Thorpe
20/10/2011 keep OUT OF THE REACH OF CHILDREN $00.00
DOWNTOWN PHARMACY
64 Brisbane St.Rerth WA 7009 Tel 6556 6556

acetaminophen

SKELAXINE TABLETS

ACETAMINOPHEN

TABLETS "CENTRAL"

COLD CAPSULES

"Y.S."

300

PYLINATON TABLETS

300MG

ANDAAbbreviated New Drug Application File Patent

Certification
DMFDrug Master File
APIActive Pharmaceutical lngredients
ANDA

DMF

File DMF
ANDA
ANDA Approval

File ANDA

Brand
Product

Portfolio
Review
9

Key
Influences

Patent
Review
2

API Sourcing
Pre-Formulation
36

/
Formulation
Pilot Biobatch
12

BA/BE
Stability
BA/BE Study
6

Business Development

CRO

API Suppliers

API Suppliers

Pre-Approval
Inspection
1218

API Suppliers

Supply Chain

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.
. 2014.01
.
ISBN 978-957-11-6968-2
1.
418.1

101027587

5L04

(423.2)

106 339 4

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(02)2706-6100

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