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100716s2010 xxu| s |||| 0|eng d |
| 020 ## - NÚMERO INTERNACIONAL NORMALIZADO PARA LIBROS |
|---|
| International Standard Book Number |
9781441964182 |
| -- |
978-1-4419-6418-2 |
| 040 ## - FUENTE DE CATALOGACIÓN |
|---|
| Transcribing agency |
MX-MeUAM |
| 050 #4 - SIGNATURA TOPOGRÁFICA DE LA BIBLIOTECA DEL CONGRESO |
|---|
| Classification number |
RS380 |
| 050 #4 - SIGNATURA TOPOGRÁFICA DE LA BIBLIOTECA DEL CONGRESO |
|---|
| Classification number |
RS190-210 |
| 082 04 - NÚMERO DE CLASIFICACIÓN DECIMAL DEWEY |
|---|
| Classification number |
615.19 |
| Edition number |
23 |
| 100 1# - ASIENTO PRINCIPAL--NOMBRE PERSONAL |
|---|
| Personal name |
Turner, J. Rick. |
| Relator term |
author. |
| 245 10 - MENCIÓN DE TITULO |
|---|
| Title |
New Drug Development |
| Medium |
[recurso electrónico] : |
| Remainder of title |
An Introduction to Clinical Trials: Second Edition / |
| Statement of responsibility, etc. |
by J. Rick Turner. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
New York, NY : |
| Name of producer, publisher, distributor, manufacturer |
Springer New York : |
| -- |
Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2010. |
| 300 ## - DESCRIPCIÓN FÍSICA |
|---|
| Extent |
XXV, 256 p. |
| Other physical details |
online resource. |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS |
|---|
| File type |
text file |
| Encoding format |
PDF |
| Source |
rda |
| 505 0# - NOTA DE CONTENIDO |
|---|
| Formatted contents note |
New Drug Development -- The Regulatory Environment -- Drug Discovery -- Nonclinical Research -- Designing Clinical Trials -- Conducting Clinical Trials I: Experimental Methodology -- Conducting Clinical Trials II: Operational Execution -- Statistical Analysis -- Statistical Significance -- Clinical Significance -- Sample Size Estimation -- General Safety Assessments -- Efficacy Assessment -- Cardiac and Cardiovascular Safety Assessments -- Manufacturing Small Molecule Drugs and Biologicals -- Postmarketing Surveillance -- Main Themes and Concluding Comments. |
| 520 ## - NOTA DE RESUMEN, ETC. |
|---|
| Summary, etc. |
New Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also excellent reading for seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise, and for students of clinical research, pharmacy, medicine, nursing, and allied health professions. While the main focus is on preapproval clinical trials, the book adopts a lifecycle drug development approach, placing these trials in the overall continuum from drug discovery to postmarketing surveillance. It therefore contains brief discussions of medicinal chemistry, nonclinical research, drug manufacturing, and the latest techniques for gathering information concerning adverse drug reactions. This edition builds on the success of the first edition by keeping the discussions that were most helpful to readers, and adding new chapters addressing important contemporary topics in drug development. The chapters dealing with the design and analysis of clinical trials in the first edition received praise from many sources. This new edition incorporates extended discussions of the operational aspects of conducting various kinds of trials, ranging from highly specialized and relatively small cardiac safety studies to very large, multi-site Phase III trials run in several different countries. |
| 596 ## - |
|---|
| -- |
19 |
| 650 #0 - ASIENTO SECUNDARIO DE MATERIA - TERMINO TEMÁTICO |
|---|
| Topical term or geographic name as entry element |
Medicine. |
| 650 #0 - ASIENTO SECUNDARIO DE MATERIA - TERMINO TEMÁTICO |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical technology. |
| 650 14 - ASIENTO SECUNDARIO DE MATERIA - TERMINO TEMÁTICO |
|---|
| Topical term or geographic name as entry element |
Biomedicine. |
| 650 24 - ASIENTO SECUNDARIO DE MATERIA - TERMINO TEMÁTICO |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical Sciences/Technology. |
| 710 2# - ASIENTO SECUNDARIO - NOMBRE CORPORATIVO |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9781441964175 |
| 856 40 - LOCALIZACIÓN Y ACCESO ELECTRÓNICOS |
|---|
| Public note |
Libro electrónico |
| Uniform Resource Identifier |
<a href="http://148.231.10.114:2048/login?url=http://link.springer.com/book/10.1007/978-1-4419-6418-2">http://148.231.10.114:2048/login?url=http://link.springer.com/book/10.1007/978-1-4419-6418-2</a> |
| 942 ## - TIPO DE MATERIAL (KOHA) |
|---|
| Koha item type |
Libro Electrónico |
