東華大學圖書館 |

Language: English

Help

回圖書館首頁

手機版館藏查詢

Back

Switch To: Labeled | MARC Mode | ISBD

Contract research and development or...

Gad, Shayne C.

Linked to FindBook

Google Book

Amazon

博客來

Contract research and development organizations = their history, selection, and utilization /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Contract research and development organizations/ by Shayne C. Gad, Charles B. Spainhour, David G. Serota.
Reminder of title:	their history, selection, and utilization /
Author:	Gad, Shayne C.
other author:	Spainhour, Charles B.
Published:	Cham :Springer International Publishing : : 2020.,
Description:	xiii, 519 p. :ill., digital ;24 cm.
[NT 15003449]:	Introduction -- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart -- The Pharmaceutical Development Process & Testing Requirements -- The Medical Device Development Process & Testing Requirements -- Functions and Types of CROs -- Labs in China and India -- Selection of CROs -- Study Directors and PIs -- Nuts and Bolts of Study Performance SCG/CBS -- Electronic Reporting Requirements (SEND & eCTD) -- Study and Project Monitoring -- Contracting, Pricing, and Cost of Works Performed by CROs -- Consultants and their Role -- Building Relationships: Maximizing your return on Expectations with a CRO -- Common Problems and their Solutions -- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists -- K Specialized Services -- L Consultants Known to be In-Practice -- Index.
Contained By:	Springer Nature eBook
Subject:	Research and development contracts. -
Online resource:	https://doi.org/10.1007/978-3-030-43073-3
ISBN:	9783030430733

Contract research and development organizations = their history, selection, and utilization /
Gad, Shayne C.

Contract research and development organizationstheir history, selection, and utilization /[electronic resource] :by Shayne C. Gad, Charles B. Spainhour, David G. Serota. - Cham :Springer International Publishing :2020. - xiii, 519 p. :ill., digital ;24 cm.

Introduction -- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart -- The Pharmaceutical Development Process & Testing Requirements -- The Medical Device Development Process & Testing Requirements -- Functions and Types of CROs -- Labs in China and India -- Selection of CROs -- Study Directors and PIs -- Nuts and Bolts of Study Performance SCG/CBS -- Electronic Reporting Requirements (SEND & eCTD) -- Study and Project Monitoring -- Contracting, Pricing, and Cost of Works Performed by CROs -- Consultants and their Role -- Building Relationships: Maximizing your return on Expectations with a CRO -- Common Problems and their Solutions -- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists -- K Specialized Services -- L Consultants Known to be In-Practice -- Index.

ISBN: 9783030430733

Standard No.: 10.1007/978-3-030-43073-3doiSubjects--Topical Terms:

988522
Research and development contracts.

LC Class. No.: TS171.4 / .G337 2020

Dewey Class. No.: 658.57

Contract research and development organizations = their history, selection, and utilization /
LDR:01985nmm a2200313 a 4500 001 2222237
003 DE-He213
005 20201109103107.0
006 m d
007 cr nn 008maaau
008 210108s2020 sz s 0 eng d
020 $a 9783030430733 $q (electronic bk.)
020 $a 9783030430726 $q (paper)
024 7 $a 10.1007/978-3-030-43073-3 $2 doi
035 $a 978-3-030-43073-3
040 $a GP $c GP
041 0 $a eng
050 4 $a TS171.4 $b .G337 2020
072 7 $a MMG $2 bicssc
072 7 $a MED071000 $2 bisacsh
072 7 $a MKG $2 thema
082 0 4 $a 658.57 $2 23
090 $a TS171.4 $b .G123 2020
100 1 $a Gad, Shayne C. $3 3460811
245 1 0 $a Contract research and development organizations $h [electronic resource] : $b their history, selection, and utilization / $c by Shayne C. Gad, Charles B. Spainhour, David G. Serota.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2020.
300 $a xiii, 519 p. : $b ill., digital ; $c 24 cm.
505 0 $a Introduction -- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart -- The Pharmaceutical Development Process & Testing Requirements -- The Medical Device Development Process & Testing Requirements -- Functions and Types of CROs -- Labs in China and India -- Selection of CROs -- Study Directors and PIs -- Nuts and Bolts of Study Performance SCG/CBS -- Electronic Reporting Requirements (SEND & eCTD) -- Study and Project Monitoring -- Contracting, Pricing, and Cost of Works Performed by CROs -- Consultants and their Role -- Building Relationships: Maximizing your return on Expectations with a CRO -- Common Problems and their Solutions -- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists -- K Specialized Services -- L Consultants Known to be In-Practice -- Index.
650 0 $a Research and development contracts. $3 988522
650 0 $a New products. $3 517687
650 1 4 $a Pharmacology/Toxicology. $3 890953
650 2 4 $a Pharmacy. $3 636101
700 1 $a Spainhour, Charles B. $3 3460812
700 1 $a Serota, David G. $3 3460813
710 2 $a SpringerLink (Online service) $3 836513
773 0 $t Springer Nature eBook
856 4 0 $u https://doi.org/10.1007/978-3-030-43073-3
950 $a Biomedical and Life Sciences (SpringerNature-11642)