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Clinical Pharmacokinetic Noncompartmental Data Analysis Plan

- i - PRIVILEGED AND CONFIDENTIAL COMMUNICATION Clinical RESEARCH IN INFECTIOUS DISEASES Clinical Pharmacokinetic Noncompartmental Data Analysis Plan For DMID Protocol: 16-0118 Study Title: A Phase 1 Clinical Trial to Evaluate the Plasma Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Zoliflodacin in Healthy Male and Female Subjects Version DATE: 03 April 2018 Prepared and Distributed by: The Emmes Corporation Rockville, Maryland USA THIS COMMUNICATION IS PRIVILEGED AND CONFIDENTIAL The Emmes Corporation Version Noncompartmental Pharmacokinetic Analysis Plan DMID Protocol: 16-0118 03 April 2018 - ii - PRIVILEGED AND CONFIDENTIAL COMMUNICATION TABLE OF CONTENTS ACRONYMS AND ABBREVIATIONS.

High-Performance Liquid Chromatography with Tandem Mass Spectrometry Ke Terminal Phase Elimination Rate Constant kg Kilogram(s) L Liter(s) LLOQ Lower Limit of Quantification Max Maximum Min Minimum min Minute(s) mL Milliliter(s) NCA Noncompartmental Analysis ng Nanogram(s) PK Pharmacokinetic(s) ...

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  Mass, Chromatography, Spectrometry, Tandem, Tandem mass spectrometry

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