عنوان
پدید آورنده
موضوع
رده
RJ560
RJ560
کتابخانه
محل استقرار
INTERNATIONAL STANDARD BOOK NUMBER
(Number (ISBN
1118312058
(Number (ISBN
1118312066
(Number (ISBN
1118312082
(Number (ISBN
1118312139
(Number (ISBN
9781118312056
(Number (ISBN
9781118312063
(Number (ISBN
9781118312087
(Number (ISBN
9781118312131
Erroneous ISBN
9781118312155
NATIONAL BIBLIOGRAPHY NUMBER
Number
dltt
TITLE AND STATEMENT OF RESPONSIBILITY
Title Proper
Pediatric drug development :
General Material Designation
[Book]
Other Title Information
concepts and applications /
First Statement of Responsibility
[edited by] Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis.
EDITION STATEMENT
Edition Statement
Second edition.
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
1 online resource
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references and index.
CONTENTS NOTE
Text of Note
pt. I. Past, present, and future of pediatric drug development -- pt. II. Ethical underpinnings -- pt. III. Regulatory guidelines for pediatric drug development -- pt. IV. Preclinical safety assessment -- pt. V. Pharmacological principles in pediatric drug development -- pt. VI. Clinical trial operations -- pt. VII. Clinical trial operations and good clinical trials -- pt. VIII. Clinical efficacy and safety endpoints -- pt. IX. Formulation, chemistry and manufacturing controls.
0
SUMMARY OR ABSTRACT
Text of Note
Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development.
OTHER EDITION IN ANOTHER MEDIUM
Title
Pediatric drug development.
International Standard Book Number
9781118312155
TOPICAL NAME USED AS SUBJECT
Drug development.
Pediatric pharmacology.
Age Factors.
Child.
Clinical Trials as Topic-- standards.
Drug Evaluation-- ethics.
Drug Evaluation-- methods.
Drug Evaluation-- standards.
(SUBJECT CATEGORY (Provisional
MED-- 023000
MED-- 058170
MED-- 071000
MED-- 072000
DEWEY DECIMAL CLASSIFICATION
Number
615/
.
190083
Edition
23
LIBRARY OF CONGRESS CLASSIFICATION
Class number
RJ560
OTHER CLASS NUMBERS
Class number
QV
771
PERSONAL NAME - ALTERNATIVE RESPONSIBILITY
Dunne, Julia,1954-
Mathis, Lisa L.
Mulberg, Andrew E.
Murphy, M. Dianne
ORIGINATING SOURCE
Date of Transaction
20181005020309.3
Cataloguing Rules (Descriptive Conventions))
rda
ELECTRONIC LOCATION AND ACCESS
Electronic name
مطالعه متن کتاب [Book]
Y
