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20130725190754.0 |
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cr nn 008mamaa |
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100301s2009 sz | s |||| 0|eng d |
| 020 |
# |
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|a 9783764383626
|9 978-3-7643-8362-6
|
| 024 |
7 |
# |
|a 10.1007/978-3-7643-8362-6
|2 doi
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| 050 |
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4 |
|a RM1-950
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| 072 |
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7 |
|a MMG
|2 bicssc
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| 072 |
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7 |
|a MED071000
|2 bisacsh
|
| 082 |
0 |
4 |
|a 615
|2 23
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| 100 |
1 |
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|a Wood, Linda Fossati.
|e editor.
|
| 245 |
1 |
0 |
|a Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
|c edited by Linda Fossati Wood, MaryAnn Foote.
|h [electronic resource] /
|
| 264 |
# |
1 |
|a Basel :
|b Birkhũser Basel,
|c 2009.
|
| 300 |
# |
# |
|b online resource.
|
| 336 |
# |
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|a text
|b txt
|2 rdacontent
|
| 337 |
# |
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|a computer
|b c
|2 rdamedia
|
| 338 |
# |
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|a online resource
|b cr
|2 rdacarrier
|
| 347 |
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|a text file
|b PDF
|2 rda
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| 505 |
0 |
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|a Regulatory writing fundamentals -- Developing a target -- Regulatory writing tips -- Templates and style guides: The nuts and bolts of regulatory documents -- Document review -- Source documents -- Protocols -- Clinical study reports -- Integrated documents -- Investigator<U+0019>s brochures -- Investigational medicinal products dossier -- Integrated summaries of safety and efficacy -- Informed consent forms -- Regulatory submissions -- Global submissions: The common technical document -- Clinical trial procedures and approval processes in Japan -- Region-specific submissions: United States of America -- Appendix.
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| 650 |
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0 |
|a Medicine.
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| 650 |
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0 |
|a Toxicology.
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| 650 |
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0 |
|a Biotechnology.
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| 650 |
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0 |
|a Pharmacy.
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| 650 |
1 |
4 |
|a Biomedicine.
|
| 650 |
2 |
4 |
|a Pharmacology/Toxicology.
|
| 650 |
2 |
4 |
|a Biotechnology.
|
| 650 |
2 |
4 |
|a Pharmacy.
|
| 700 |
1 |
# |
|a Foote, MaryAnn.
|e editor.
|
| 710 |
2 |
# |
|a SpringerLink (Online service)
|
| 773 |
0 |
# |
|t Springer eBooks
|
| 776 |
0 |
8 |
|i Printed edition:
|z 9783764383619
|
| 856 |
4 |
0 |
|u https://ezaccess.library.uitm.edu.my/login?url=http://dx.doi.org/10.1007/978-3-7643-8362-6
|
| 912 |
# |
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|a ZDB-2-SBL
|
| 950 |
# |
# |
|a Biomedical and Life Sciences (Springer-11642)
|