NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Smith PB, Smith MJ, Gonzalez D, et al. Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects with BMI ≥ 85th Percentile [Internet]. Bethesda (MD): National Institute of Child Health and Human Development (US); 2015 Oct 15.
Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects with BMI ≥ 85th Percentile [Internet].
Show details- 16.1.
Study Information - NICHD-2012-CLN01
- 16.1.1.
- 16.1.2.
Sample Case Report Form
- 16.1.3.
Institutional Review Boards (IRBs) and Consent/Assent Information
- 16.1.4.
Description of Investigators
- 16.1.5.
Signature Pages
- 16.1.6.
Listing of Lot Numbers by Participant
- 16.1.7.
Randomization Scheme
- 16.1.8.
Audit Certificates
- 16.1.9.
Statistical Analysis Plan
- 16.1.10.
Documentation of Inter-Laboratory Standardization Methods and Quality Assurance Procedures
- 16.1.11.
Publications Based on the Study
- 16.1.12.
Important Publications Referenced in the Report
- 16.2.
Participant Data Listings - CLN01
- 16.3.
Case Report Forms for Participant with SAE - CLN01
- 16.4.
Miscellaneous
- 16.4.1.
NICHD-2011-POP01 Protocol and Protocol Amendments
- 16.4.2.
NICHD-2012-STA01 Protocol and Protocol Amendments
- 16.4.4.
Clindamycin Assay Validation Report
- 16.4.5.
NICHD-2012-CLN01 Interim Analysis Report
- 16.5.
Datasets and Define.pdf - CLN01
For documents listed but not available for download, please check the DASH repository at https://dash.nichd.nih.gov/study/228258
- APPENDICES (list of contents) - Safety and Pharmacokinetics of Multiple-Dose Int...APPENDICES (list of contents) - Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects with BMI ≥ 85th Percentile
Your browsing activity is empty.
Activity recording is turned off.
See more...