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BOOKS || E-BOOK SHELF 6: REGULATORY AFFAIRS PROSPECTIVE FOR ANDA SUBMISSIONS
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BOOK DETAILS:
REGULATORY AFFAIRS PROSPECTIVE FOR ANDA SUBMISSIONS
by SANYAM GANDHI, AKHILESH TIWARI & AJAY SHARMA
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ISBN |
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Name |
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REGULATORY AFFAIRS PROSPECTIVE FOR ANDA SUBMISSIONS |
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Price |
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Updated soon |
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Edition |
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1st |
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Author/s |
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SANYAM GANDHI, AKHILESH TIWARI & AJAY SHARMA |
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Type |
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Text Book |
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Pages |
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230 |
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Year of Publication |
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2021 |
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Publisher |
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ASIO/ CAB |
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Format &Stock Status |
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e-Book available |
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DOI Link :: http://doi-ds.org/doilink/10.2016-74831794/; DOI Link :: |
| Language | : | English |
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Chapter |
Title |
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Title page |
i |
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Preface |
ii |
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Authors details |
iii |
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Acknowledgement |
v |
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Table of Contents |
vi |
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List of Tables |
viii |
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List of Figure |
ix |
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1 |
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Introduction |
1 |
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2 |
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Abbreviated New Drug Application |
3 |
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2.1 |
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Background of Abbreviated New Drug Application |
4 |
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2.2 |
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Laws, Regulations, Policies and Procedures |
8 |
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2.2.1 |
Code Of Federal Regulations (CFR) |
16 |
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2.2.2 |
Content and format of ANDA as per 21 CFR part 314. |
24 |
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2.2.3 |
Submitting and Reviewing ANDA |
32 |
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2.3 |
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About Patent and 180-days period of Exclusivity |
42 |
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2.4 |
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Orange Book |
44 |
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2.5 |
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Chemistry, Manufacturing and Control Requirement |
56 |
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2.6 |
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Drug Master Files |
60 |
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2.7 |
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Bioequivalence studies for ANDA |
72 |
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2.7.1 |
documentation of BA and BE |
75 |
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3 |
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Common Technical Document (CTD) |
80 |
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3.1 |
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A Brief History of ICH |
86 |
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3.2 |
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Commitment and Process |
89 |
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3.3 |
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The Early meetings and Conferences |
93 |
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3.4 |
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ICH organization |
99 |
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3.4.1 |
Members |
105 |
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3.4.2 |
The Steering Committee |
112 |
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3.4.3 |
Expert Working Group (EWGS) |
119 |
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3.5 |
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Status of ICH harmonisation initiatives |
125 |
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3.6 |
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Common Technical Document |
130 |
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3.6.1 |
ICH 5 meeting report |
136 |
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3.6.2 |
Electronic Common Technical Document (eCTD) |
140 |
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3.6.3 |
Implementation of the CTD |
146 |
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3.7 |
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Hurdles for Harmonisation of the Content of Modules |
150 |
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3.7.1 |
Quality |
159 |
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3.7.2 |
Safety and Efficacy |
170 |
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4 |
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Compilation of ANDA in CTD |
182 |
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4.1 |
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Background |
189 |
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4.2 |
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CTD format for ANDA submission |
192 |
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4.2.1 |
Format for Module 1 |
199 |
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4.2.2 |
Format for Module 2 |
206 |
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4.2.3 |
Format for Module 3 |
207 |
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4.2.4 |
Format for Module 5 |
209 |
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4.2.5 |
General Issues for Submissions |
211 |
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5 |
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Conclusion |
215 |
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6 |
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References |
218 |
Authors Information:
Sanyam Gandhi is working as GEM Regulatory Affairs Strategy Lead in Takeda pharmaceuticals at the Cambridge, MA, USA. He completed bachelor’s and master’s in pharmacy from India. He has extensive experience in field of Pharmaceuticals and Regulatory Affairs. He completed certification programs from known institutes Harvard University, Boston, USA and Regulatory Affairs Professionals Society, USA.
Sanyam Gandhi worked with many major pharmaceutical companies like GSK, TEVA, Catalent, Ranbaxy and Shire in India, United Kingdom and USA.
Sanyam Gandhi is active member in the different pharmaceutical associations for example TOPRA (The Organisation for Professionals in Regulatory Affairs, UK), RAPS (Regulatory Affairs Professionals Society, USA), Royal Pharmaceutical Society, UK and Pharmacy Council of India, PCI.
He published many scientific research and review articles, books on different pharmaceutical subjects but Regulatory affairs is area of his excellence. He is also Editor in many scientific journals, International Journal of Pharmaceutical and Biological Science, International Journal of Medical and Biomedical Studies, International Journal of Medical Studies and Clinical Research. Journal of Drug Discovery and Therapeutics (JDDT) and his contribution is immense in Pharmaceutical field. This book is also part of this series.
Salient Features:
Background
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
