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Guidebook for Drug Regulatory Submissions By Weinberg Sandy | Hardcover
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“READ BELOW!”
Good
A book that has been read but is in good condition. Very minimal damage to the cover including scuff marks, but no holes or tears. The dust jacket for hard covers may not be included. Binding has minimal wear. The majority of pages are undamaged with minimal creasing or tearing, minimal pencil underlining of text, no highlighting of text, no writing in margins. No missing pages. See the seller’s listing for full details and description of any imperfections.
- Buy It NowGuidebook for Drug Regulatory Submissions By Weinberg Sandy | Hardcover
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eBay item number:266625867301
Item specifics
- Condition
- Good
- Seller Notes
- “READ BELOW!”
- Brand
- Unbranded
- Book Title
- Guidebook for Drug Regulatory Submissions
- MPN
- Does not apply
- ISBN
- 9780470371381
- Subject Area
- Medical
- Publication Name
- Guidebook for Drug Regulatory Submissions
- Publisher
- Wiley & Sons, Incorporated, John
- Item Length
- 9.6 in
- Subject
- Pharmacology
- Publication Year
- 2009
- Type
- Textbook
- Format
- Hardcover
- Language
- English
- Item Height
- 1.1 in
- Item Weight
- 25.3 Oz
- Item Width
- 6.4 in
- Number of Pages
- 400 Pages
About this product
Product Identifiers
Publisher
Wiley & Sons, Incorporated, John
ISBN-10
0470371382
ISBN-13
9780470371381
eBay Product ID (ePID)
70894032
Product Key Features
Number of Pages
400 Pages
Publication Name
Guidebook for Drug Regulatory Submissions
Language
English
Publication Year
2009
Subject
Pharmacology
Type
Textbook
Subject Area
Medical
Format
Hardcover
Dimensions
Item Height
1.1 in
Item Weight
25.3 Oz
Item Length
9.6 in
Item Width
6.4 in
Additional Product Features
Intended Audience
Scholarly & Professional
LCCN
2008-044679
Reviews
"The Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development." ( Pharmaceutical Outsourcing , April 2009)
Dewey Edition
22
Illustrated
Yes
Dewey Decimal
344.7304/233
Table Of Content
Preface ix Chapter 1 Ten Rules for Drug Regulatory Submissions 1 Chapter 2 FDA Meeting Requests 44 Chapter 3 Orphan-Drug Applications 64 Chapter 4 Investigational New Drug Applications (INDs) 82 Chapter 5 New Drug Applications (NDAs) 120 Chapter 6 505(b)2 New Drug Applications (NDAs) 183 Chapter 7 Abbreviated New Drug Applications (ANDAs) 255 Chapter 8 Annual Reports 288 Chapter 9 International Regulatory Submissions 315 Carl A. Rockburne Chapter 10 Future Issues in Regulatory Submissions 355 Index 367
Synopsis
Destined to become every regulatory directors essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions., Destined to become every regulatory director's essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide--it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions., The high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the inexperienced regulatory professional charged with preparing a major regulatory submission.
LC Classification Number
KF3885W45 2009
Item description from the seller
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- l***c (248)- Feedback left by buyer.Past 6 monthsVerified purchaseItem arrived nicely packed and in excellent quality condition. I need this book for dissertation research, and it is not in my University's or local library. I was very happy to find this seller 's offer of value and speedy service!College Students' Sense of Belonging: A Key to Educational Success for All Stud, (#266312381315)
- h***1 (938)- Feedback left by buyer.Past 6 monthsVerified purchaseShipping was fast with careful packaging. The book is as described and arrived in great condition. The quality and appearance are like new. Thank you for great service
- 2***2 (226)- Feedback left by buyer.Past 6 monthsVerified purchaseItem as described. Well packaged and quick shipment. Great transaction. ThanksHP 952XL F6U19AN Black Ink Cartridge NEW GENUINE Officejet 8710 8210 Exp: Nov 25 (#267250767710)