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Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Doxycycline
Clinical Study Report
Chiara Melloni, MD, MHS; Michael Cohen-Wolkowiez, MD, PhD; Ravinder Anand, PhD and Elizabeth H. Payne, PhD. Danny K. Benjamin, MD, MPH, PhD.
Author Information and Affiliations| Protocol ID: | NICHD-2011-POP01 |
| Development Phase: | Phase 1 |
| Investigational Product: | Doxycycline |
| IND Number: | TBD |
| Date of Inclusion of First Participant: | March 12, 2012 |
| Date of Completion of Last Participant: | February 2, 2016 |
| Indication Studied: | Treatment of infections caused by susceptible microorganisms |
| Methodology: | Multiple-center, prospective, opportunistic PK study |
Contents
- 2. SYNOPSIS
- 4. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
- 5. ETHICS
- 6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
- 7. INTRODUCTION
- 8. STUDY OBJECTIVES
- 9. INVESTIGATIONAL PLAN
- 10. DISPOSITION OF PARTICIPANTS
- 11. EVALUATION OF PHARMACOKINETICS
- 12. SAFETY EVALUATION
- 13. DISCUSSION AND OVERALL CONCLUSIONS
- 14. TABLES, FIGURES, AND GRAPHS REFERRED TO BUT NOT INCLUDED IN THE TEXT
- 15. REFERENCE LIST
- 16. APPENDICES
Study data is available on the DASH repository at https://dash.nichd.nih.gov/study/19016
This study was conducted in compliance with Good Clinical Practices (GCP) as outlined by the International Council on Harmonization (ICH), including the archiving of essential documents. All unpublished information contained within this report is confidential and the sole property of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- NLM CatalogRelated NLM Catalog Entries
- Pharmacokinetics of Understudied Drugs Administered to Children per Standard of ...Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Doxycycline
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