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01726nam a22003255i 4500 |
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20220404150256.0 |
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cr nn 008mamaa |
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100301s2009 sz | s |||| 0|eng d |
| 020 |
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|a 9783764383626
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| 024 |
7 |
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|a 10.1007/978-3-7643-8362-6
|2 doi
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| 040 |
|
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|a Sistema de Bibliotecas del Tecnológico de Costa Rica
|
| 245 |
1 |
0 |
|a Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics /
|c edited by Linda Fossati Wood, MaryAnn Foote.
|
| 250 |
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|a 1st ed. 2009.
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| 260 |
# |
# |
|a Basel :
|b Birkhäuser Basel :
|b Imprint: Birkhäuser,
|c 2009.
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| 300 |
|
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|a X, 238 p. 26 illus. :
|b online resource.
|
| 336 |
|
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|a text
|b txt
|2 rdacontent
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| 337 |
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|a computer
|b c
|2 rdamedia
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| 338 |
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|a online resource
|b cr
|2 rdacarrier
|
| 505 |
0 |
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|a Regulatory writing fundamentals -- Developing a target -- Getting started -- 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’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.
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| 650 |
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0 |
|a Pharmacology.
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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 Pharmacology/Toxicology.
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| 650 |
2 |
4 |
|a Biotechnology.
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| 650 |
2 |
4 |
|a Pharmacy.
|
| 700 |
1 |
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|a Wood, Linda Fossati.
|e editor.
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| 700 |
1 |
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|a Foote, MaryAnn.
|e editor.
|
| 710 |
2 |
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|a SpringerLink (Online service)
|
| 773 |
0 |
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|t Springer eBooks
|