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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.

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Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects with BMI ≥ 85th Percentile [Internet].

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4GLOSSARY OF ABBREVIATIONS AND TERMS

AE

Adverse Event

ALT

Alanine Transaminase

AST

Aspartate Transaminase

AUC

Area Under the Concentration Time Curve

BPCA

Best Pharmaceuticals for Children Act

BMI

Body Mass Index

CDC

Centers for Disease Control and Prevention

CFR

Code of Federal Regulations

CL

Clearance

Cl/F

Oral Apparent Clearance

CRF

Case Report Form

CYP

Cytochrome

DCC

Data Coordinating Center

DCRI

Duke Clinical Research Institute

DMC

Data Monitoring Committee

ECLS

Extracorporeal Life Support

EDC

Electronic Data Capture

FDA

Food and Drug Administration

FFM

Free Fat Mass

NFM

Normal Fat Mass

GCP

Good Clinical Practice

HIPAA

Health Insurance Portability and Accountability Act

IBW

Ideal Body Weight

ICH

International Conference on Harmonisation

ICMJE

International Committee of Medical Journal Editors

IND

Investigational New Drug Application

IRB

Institutional Review Board

IV

Intravenous

kg

Kilogram

LBW

Lean Body Weight

MedDRA

Medical Dictionary for Regulatory Activities

MIC

Minimum Inhibitory Concentration

mg

Milligram

MOP

Manual of Procedures

MRSA

Methicillin-resistant Staphylococcus aureus

N

Number (typically refers to participants)

NFM

Normal Fat Mass

NICHD

National Institute of Child Health and Human Development

NIH

National Institutes of Health

NPO

Nothing by Mouth

PD

Pharmacodynamics

PG

Pharmacogenomic

PK

Pharmacokinetics

PO

Oral

PTN

Pediatric Trials Network

SAE

Serious Adverse Event

Half-life

V

Volume of Distribution

WT

Total Body Weight

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