Rabu, 26 Mei 2010

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Destined to become every regulatory director's essential desktop companion

rofessionals 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.

  • Sales Rank: #1056033 in Books
  • Published on: 2009-03-11
  • Original language: English
  • Number of items: 1
  • Dimensions: 9.65" h x 1.05" w x 6.40" l, 1.40 pounds
  • Binding: Hardcover
  • 392 pages

Review
“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)

About the Author

SANDY WEINBERG is the former Vice President for Regulatory Affairs and Quality Assurance at Tikvah Therapeutics, Inc., and is now Associate Professor of Health Care Management and Director of the Master in Health Administration Graduate Program at Clayton State University in Atlanta. He has thirty years of experience in the field of drug regulatory affairs and is the author of twelve books, most recently Good Laboratory Practice Regulations, Fourth Edition.

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Selasa, 25 Mei 2010

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  • Sales Rank: #1303381 in eBooks
  • Published on: 2012-12-21
  • Released on: 2012-12-21
  • Format: Kindle eBook

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Kamis, 20 Mei 2010

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  • Chapters provide an invaluable resource for academics, researchers and students alike
  • Iinternational board of authors
  • This volume is split into sections that cover subjects such as Antibodies, Protein conjugates, Peptides, Enzymes and Scaffolds

  • Sales Rank: #5859489 in Books
  • Published on: 2012-01-25
  • Original language: English
  • Number of items: 1
  • Dimensions: 9.02" h x .0" w x 5.98" l, .0 pounds
  • Binding: Hardcover
  • 392 pages

From the Back Cover

This volume of Methods in Enzymology looks at Protein Engineering for Therapeutics. The chapters provide an invaluable resource for academics, researchers and students alike. With an international board of authors, this volume is split into sections that cover subjects such as Antibodies, Protein conjugates, Peptides, Enzymes and Scaffolds

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  • Sales Rank: #1352848 in Books
  • Brand: Brand: Amberley
  • Published on: 2012-12-24
  • Original language: English
  • Number of items: 1
  • Dimensions: 9.00" h x .83" w x 6.00" l, .0 pounds
  • Binding: Hardcover
  • 288 pages
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Praise for Norah Lofts: 'The narrative has pace, the characters substance, the finale a powerful twist and the sense of period is rich and authentic' THE SUNDAY TIMES; 'Norah Lofts is a capable and professional writer, a natural storyteller whose characters are neatly and believably portrayed: whose prose is smooth and readable' THE NEW YORK TIMES.

About the Author
Norah Lofts was one of the best-known and best-loved of all historical novelists and many of her books remain in print today. Anne Boleyn is one of her rare - yet highly successful - forays into non-fiction and displays her trademark application of authentic period detail to a gripping narrative. Her fictionalised account of Anne Boleyn's life, The Concubine, was a huge bestseller in the UK and US. Lofts wrote more than fifty books.

Most helpful customer reviews

22 of 26 people found the following review helpful.
A good, quick read!
By A Customer
This biography of Anne Boleyn is short and quite accurate. There are a ton of illustrations in the book that really contribute to the overall effect. I life the fact that the author didn't overly sypathize with Mistress Anne but didn't try to persecute her either.
A great book for someone who wants to learn more about history but doesn't have time to delve into a 500 page book that is full of dry, useless information.

15 of 17 people found the following review helpful.
Norah Loft's Anne Boleyn
By sema4dogz
Norah Lofts is a historical novelist of the first water- she did her best work in the forties and fifties and has a small but devoted following ( see Goodreads, or Flork or Allreaders)
Most of her ouevre is fiction, featuring ordinary people as well as royalty, but always meticulously researched and devoid of the purple prose and fervid imagined sexual detail of later writers. However she also had a respectable output of non fiction.
'Anne Boleyn', like 'Women in the New Testament' or any of her other non-fiction is completely readable , but intelligently researched and structured. Always a pleasure Norah Lofts, always.
One aspect of note in Norah Lofts -fiction or non fiction- is that once you have read her version of some historical figure, it is hard to accept anyone else's as being quite as real . A bit like Mary Renault's version of Alexander Great.

11 of 12 people found the following review helpful.
A fond memory....
By Rashchupkina
I just got this book again because this is the book I checked out from the library when I was 12 which started my lifelong enchantment, fascination and passion for Anne....and for english history. It's an easy, but very informative read. And there are many gorgeous illustrations, and some unusual ones as well.

Lofts always has a wonderful sense of history and her writing is intuitive and deeper than most.

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