| 000 -LEADER |
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03865nam a22004695i 4500 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20140310150235.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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110801s2011 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781461400493 |
|
978-1-4614-0049-3 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RM1-950 |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615 |
| Edition number |
23 |
| 264 #1 - |
|---|
| -- |
New York, NY : |
| -- |
Springer New York : |
| -- |
Imprint: Springer, |
| -- |
2011. |
| 912 ## - |
|---|
| -- |
ZDB-2-SBL |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Gad, Shayne C. |
| Relator term |
author. |
| 245 10 - IMMEDIATE SOURCE OF ACQUISITION NOTE |
|---|
| Title |
Contract Research and Development Organizations |
| Medium |
[electronic resource] : |
| Remainder of title |
Their Role in Global Product Development / |
| Statement of responsibility, etc |
by Shayne C. Gad, Charles B. Spainhour. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
XII, 212p. 4 illus. |
| Other physical details |
online resource. |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Introduction -- The pharmaceutical Development Process & Testing Requirements -- The Medical Device Development Process & Testing Requirements -- Functions and Types of CROs (referencing function listings in appendices) -- Selection of CROs -- Labs in China and India -- Contracting, Pricing, and Cost of Works Performed by CROs -- Monitoring Ongoing Studies and Work -- Common Problems and their Solutions -- Appendix. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Medicine. |
|
|---|
| Topical term or geographic name as entry element |
Toxicology. |
|
|---|
| Topical term or geographic name as entry element |
Biotechnology. |
|
|---|
| Topical term or geographic name as entry element |
Biochemistry. |
|
|---|
| Topical term or geographic name as entry element |
Pharmacy. |
|
|---|
| Topical term or geographic name as entry element |
Biomedicine. |
|
|---|
| Topical term or geographic name as entry element |
Pharmacology/Toxicology. |
|
|---|
| Topical term or geographic name as entry element |
Biotechnology. |
|
|---|
| Topical term or geographic name as entry element |
Medicinal Chemistry. |
|
|---|
| Topical term or geographic name as entry element |
Pharmacy. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Spainhour, Charles B. |
| Relator term |
author. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| 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 |
|---|
| Display text |
Printed edition: |
| International Standard Book Number |
9781461400486 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
http://dx.doi.org/10.1007/978-1-4614-0049-3 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
|
| Item type |
E-Book |
