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" Pediatric drug development : "
[edited by] Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis.
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BL
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| Record Number
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640509
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| Doc. No
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dltt
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| Title & Author
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Pediatric drug development : : concepts and applications /\ [edited by] Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis.
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| Edition Statement
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Second edition.
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| Page. NO
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1 online resource
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| ISBN
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9781118312056
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: 1118312058
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: 9781118312063
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: 1118312066
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: 9781118312131
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: 1118312139
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: 9781118312087
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: 1118312082
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9781118312155
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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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.
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| Abstract
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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.
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| Subject
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Pediatric pharmacology.
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Drug development.
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Child.
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Drug Evaluation-- methods.
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Age Factors.
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Clinical Trials as Topic-- standards.
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Drug Evaluation-- ethics.
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Drug Evaluation-- standards.
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| Dewey Classification
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615/.190083
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| LC Classification
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RJ560
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| NLM classification
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QV 771
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| Added Entry
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Mulberg, Andrew E.
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Murphy, M. Dianne
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Dunne, Julia,1954-
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Mathis, Lisa L.
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