Registration Process of Generic Budesonide DPI as per USFDA Guidelines: Dossier Submission of Budesonide Dry Powder Inhaler with the application of eCTD Software

Gandhi, Hansal

ISBN 10: 6200080941 / ISBN 13: 9786200080943

Published by LAP LAMBERT Academic Publishing, 2019

About this Item

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Bibliographic Details

• Title: Registration Process of Generic Budesonide DPI as per USFDA Guidelines: Dossier Submission of Budesonide Dry Powder Inhaler with the application of eCTD Software
• Publisher: LAP LAMBERT Academic Publishing
• Publication Date: 2019
• Language: English
• ISBN 10: 6200080941
• ISBN 13: 9786200080943
• Binding: Paperback
• Condition: Good

About this title

Synopsis

The purpose of this book is to develop a hypothetical dossier based on regulations and guidances which are required to be followed when an actual submission is filed to the USFDA, with an objective to meet the Common Technical Document(CTD) requirements. For this purpose, Budesonide Dry Powder Inhaler(DPI) is selected as a product to prepare a hypothetical dossier. In terms of volume by 2026 it is expected that requirement of DPI in USA would be increased and may reach up to 400 million units per year due to increasing air pollution and increased rate of respiratory diseases in children as well as old age people. In this study an ANDA has been prepared which includes data of the different modules such as Module 1: Administrative Information, Module 2: Quality Overall Summary, Module 3: Quality (Drug substance and Drug product) and Module 5: Clinical Study Reports. To get the ANDA approval, generic applicants has to show scientific evidence that their product is bioequivalent to the innovators drug product. Once the application is submitted it will undergo through a thorough review process by CDER, OGD & OCP and if they find it satisfactory, product will get approval from FDA.