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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.

Cover of Ampicillin Pharmacokinetics and Safety in Infants

Ampicillin Pharmacokinetics and Safety in Infants [Internet].

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16APPENDICES

16.1.

Study Information

16.1.1.

Protocol and Protocol Amendments (NICHD-2012-AMP01)

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.

PPRU Study Report

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.

PK Report

16.4.4.2.

PK Tables

16.4.4.3.

PK Figures

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

16.5.1.

Description of Datasets

16.5.2.

NICHD-2011-POP01 Dataset

16.5.3.

PPRU Dataset

16.5.4.

NICHD-2011-POP01 Pharmacokinetic Dataset

16.5.5.

Data Dictionaries

For documents listed but not available for download, please check the DASH repository at https://dash.nichd.nih.gov/study/20222

Bookshelf ID: NBK574267

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