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Contents

Larisa Wu 1.1 Introduction 1 1.2 Peptide Quality Assessment at the FDA 2 1.3 Overview of the Current Drug Approval Process Employed for Peptide Applications 2 1.3.1 The New Drug Application Assessment Process 3 1.3.2 Abbreviated New Drug Application Assessment Process 13 1.3.3 Post-approval Activiti...

Publication details


Print publication date
28 Aug 2019
Copyright year
2019
Print ISBN
978-1-78801-433-5
PDF eISBN
978-1-78801-644-5
From the book series:
Drug Discovery