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Pediatric drug development : concepts and applications / edited by Andrew E. Mulberg, Steven A. Silber, John N. van den Anker.
- Format:
- Book
- Language:
- English
- Subjects (All):
- Pediatric pharmacology.
- Drug development.
- Physical Description:
- 1 online resource (705 p.)
- Edition:
- 1st ed.
- Place of Publication:
- Hoboken, N.J. : John Wiley, c2009.
- Language Note:
- English
- Summary:
- Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholder
- Contents:
- PEDIATRIC DRUG DEVELOPMENT; CONTENTS; PREFACE; CONTRIBUTORS; PART I PAST, PRESENT, AND FUTURE OF PEDIATRIC DRUG DEVELOPMENT; PART II ETHICAL UNDERPINNINGS; PART III REGULATORY GUIDELINES FOR PEDIATRIC DRUG DEVELOPMENT: STIMULATION OF PEDIATRIC DRUG RESEARCH BY REGULATORY AUTHORITIES; PART IV PRECLINICAL SAFETY ASSESSMENT; PART V PHARMACOLOGICAL PRINCIPLES IN PEDIATRIC DRUG DEVELOPMENT; PART VI CLINICAL TRIAL OPERATIONS: UNDERSTANDING DIFFERENCES BETWEEN PEDIATRIC AND ADULT STUDY SUBJECTS-DEVELOPMENT ISSUES RELATED TO ORGAN DEVELOPMENT AND ENDPOINT CHOICES
- PART VII CLINICAL TRIAL OPERATIONS AND GOOD CLINICAL TRIALSPART VIII CLINICAL EFFICACY AND SAFETY ENDPOINTS; PART IX FORMULATION, CHEMISTRY, AND MANUFACTURING CONTROLS; PART X CASE STUDIES: SUCCESSES FOR CHILDREN; APPENDIX Reference Tables and Figures; INDEX
- Notes:
- Description based upon print version of record.
- Includes bibliographical references and index.
- ISBN:
- 1-118-21043-3
- 1-283-91556-1
- 0-470-93048-9
- OCLC:
- 659500747
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