NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Benjamin DK Jr., Lewandowski A, Anand R. Ampicillin Pharmacokinetics and Safety in Infants [Internet]. Bethesda (MD): National Institute of Child Health and Human Development (US); 2014 Nov 24.
- 16.1.
Study Information
- 16.1.1.
- 16.1.2.
Sample Case Report Form (NICHD-2011-POP01)
- 16.1.3.
Institutional Review Boards (IRBs) and Participant Consents and Information (NICHD-2011-POP01)
- 16.1.4.
Description of Investigators (NICHD-2011-POP01)
- 16.1.5.
CSR Signature Page
- 16.1.6.
Listing of Batch Numbers by Patient
- 16.1.7.
Randomization Scheme and Codes
- 16.1.8.
Audit Certificates
- 16.1.9.
Statistical Analysis Plan (NICDH-2011-POP01)
- 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
- 16.1.13.
Written Request
- 16.2.
Participant Data Listings (NICHD-2011-POP01)
- 16.3.
Case Report Forms for Participants with SAEs
- 16.4.
Miscellaneous
- 16.4.1.
Protocol for Study NICHD-2011-POP01
- 16.4.2.
- 16.4.3.
Pediatrix Database Report
- 16.4.3.1.
Ampicillin Safety in Hospitalized Infants (Analysis of the Pediatrix Database) – Report
- 16.4.3.2.
Description of Pediatrix Datasets
- 16.4.3.3.
Pediatrix Data Dictionary
- 16.4.4.
Pharmacokinetic Report - NICHD-2011-POP01
- 16.4.4.1.
- 16.4.4.2.
- 16.4.4.3.
- 16.4.4.4.
PK Listings
- 16.4.4.5.
NONMEM Control Stream
- 16.4.5.
Sample Bioanalysis Report
- 16.5.
Datasets and Define.pdf
For documents listed but not available for download, please check the DASH repository at https://dash.nichd.nih.gov/study/20222
- APPENDICES - Ampicillin Pharmacokinetics and Safety in InfantsAPPENDICES - Ampicillin Pharmacokinetics and Safety in Infants
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