Showing posts with label medical writing. Show all posts
Showing posts with label medical writing. Show all posts

5/14/2012

American Medical Association Manual of Style : A Guide for Authors and Editors (AMA) Review

American Medical Association Manual of Style : A Guide for Authors and Editors (AMA)
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The specific goal of the American Medical Association Manual of Style: A Guide for Authors and Editors is to codify and collect the myriad instructions, rules, and dictums that AMA applies to the many journals, books, and other publications that are printed under its imprint. The more general goal, perhaps not stated, is to broaden the influence of those standards so they encompass more of the medical publishing community.
The book, developed by a committee of writers, editors, and publishers, is organized around five major categories, Preparing an Article for Publication, Style, Terminology, Measurement and Quantitation, and Technical Information. Each of these categories is, in turn, broken down into chapters that probe various aspects of each category. Finding information is easy, and the writers have used examples generously to make the points clear.
The first section, Preparing an Article for Publication, is, naturally slanted more toward authors and those who toil to prepare author's manuscripts for publication. There are many guidelines offering advice that ranges from preparing the abstract to preparing any of six different types of acknowledgments. Editors and copy editors would do well to review this chapter as well. The section on citing Web sites alone is crucial reading.
I suspect, but cannot prove, that many researchers will not read deeply beyond the opening chapter, feeling that the remaining sections are more the province of copy editors and journal editors. Perhaps there is some merit to that line of thinking, but all authors in the medical sciences would benefit from the copious advice here, and the better writers, I'm sure, do follow the principles of grammar, punctuation, capitalization, and usage set forth in the section on style. Common mistakes, such as confusing case and patient, redundancies, and the ever so ticklish topic of race/ethnicity are some of the many points discussed thoroughly.
The section on terminology is so mind-bogglingly detailed that all one can hope to do is remember that the AMA Style Guide will almost always have the answer if you have a question about an abbreviation (how many times is something mistakenly called an acronym instead of an initialism?), medical nomenclature (a huge chapter that is the heart of the book), or eponyms (which, thanks to this guide may now be a topic we can quit haggling over).
Measurement and Quantitation continue to be a bane for many writers and editors, though without delving too much into specifics, let's say that this section will answer most questions but not without careful reading and perhaps a look at the Chicago Manual of Style for a bit clearer presentation on this topic. The chapter on statistics, unique to this guide, notes how to express confidence intervals, confirms that the word Student in Student t test is capitalized (sorry, but this text editor on Amazon.com does not display the italic t), provides a list of statistical symbols and abbreviations, and offers valuable tips about displaying equations. And those examples barely hint at the wealth of information here.
A final section on technical information provides a thumbnail guide to good layout and design of printed materials, worthy sets both of copyediting marks and proofreading marks (which are no doubt often photocopied and posted in a visible location), an excellent primer on how to edit hard copy, and a glossary of publishing terms.
If you are a medical writer or editor, odds are that you already either have a copy of this guide or you borrow one from a colleague. If you are an aspiring medical communicator, you will need your own copy so you can mark in it, attach tabs, and leave open on your desk.

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The latest edition features an expanded chapter on legal and ethical concerns in publishing. Readers will also find an extensive chapter on statistics, a completely updated chapter on nomenclature, new policies for eponyms and numbers styles, a larger references section, an expanded discussion of inclusive language and abbreviations, and a larger section on figures and tables. A new section on typography is also featured, along with current information on electronic publishing, encompassing rapid changes affecting the publishing environment. End-of-chapter references make the book easier to use, and the entire text is reviewed by more than 70 editors for accuracy and dependability.

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4/20/2012

AMA Manual of Style: A Guide for Authors and Editors: Special Online Bundle Package Review

AMA Manual of Style: A Guide for Authors and Editors: Special Online Bundle Package
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At long last, the 10th Edition of the AMA Manual of Style is finally available, and I am happy to say it was worth the wait. As an editor who has worked in medical journals, scientific Web sites, and an agency specializing in pharmaceutical advertising, I found the 9th edition to be, at times, a bit dated and not as easy to navigate as I would have hoped. Most of those problems have been resolved in the 10th edition, as well as the inclusion of some new information that I didn't even know I was missing until I found.
The following is a list of changes in the new edition of the style guide that I found particularly helpful and relevant, and will hopefully be a quick go-to guide when you're debating whether to buy the new version or hold fast to the 9th edition.
- The section on Correct and Preferred Usage has moved from Chapter 9 to Chapter 11 and includes a wealth of information that was not in the previous edition. There is more information about the difference between race and ethnicity and when it's relevant to include sexual orientation in a scientific manuscript.
- An extended section on electronic references (3.15, 63-72). This new info is highly relevant considering since 1998 (when the 9th edition was released) there have been a number of innovations with the Internet and a number of authors choose to use the Web as sources of information.
- The section on manuscript preparation is vastly improved and expanded (Ch 4). It includes more information on the different types of tables and figures as well as new guidelines for the use of symbols and footnotes.
- Of particular interest to journal editors, there is more information on authorship requirements, conflicts of interest, sources of funding, and copyright and permissions basics (Ch 5).
- The section on capitalization demonstrates that, not only can the AMA editors laugh at themselves, but that they're also familiar with the lyrics of Coolio (eg, There is no party like a West Coast party because a West Coast party doesn't stop. 10.3, 375). The section on capitalization also includes newer terms like iBook and eBay that are more relevant to modern writing (10.8, 380).
- In terms of grammar, some of the rules that always give editors trouble are more explicitly outlined and in more detail. There's a longer section on the use of that and which (7.2, 318), which I still have to look up occasionally. A final ruling on the health care vs healthcare debate (always 2 words, per AMA, 11.1, 395). And more specific rules on false/parenthetical plurals and sentences with compound subjects (7.8)
- A change in the use of states in references. All will use postal codes now, instead of the former abbreviations (14.5, 451-455).
- An expanded section on international currency (18.5.12, 817-819).
- The section on terminology has been expanded to include information about different specialties, including psychiatry, ophthalmology, and obstetrics (Ch 15). This section also includes a new chart with human viruses that is expanded and easier to navigate (15.14.3, 762-767).
- There is a more comprehensive copyediting section, including information on editing numerical information (21.1, 907; 23.1, 929-933).
- And finally, and most importantly for all newer medical editors and writing, there is a more informative resources guide with professional organizations aimed at scientific writers and editors as well as grammar and editing resources (25, 967-976).
As a whole, I'm very pleased with the new edition of the AMA style guide, and can't wait to incorporate the new changes into my own work.

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The AMA Manual of Style is a must-have guide for those seeking to publish research findings and anyone involved in medical or scientific publishing. But more than just a style manual, it offers guidance on how to navigate the dilemmas that authors, researchers and their institutions, medical editors and publishers, and members of the news media who cover scientific research confront on a daily basis. Written by an expert committee of JAMA and Archives editors, this 10th edition thoroughly covers ethical and legal issues, authorship, conflicts of interest, scientific misconduct, and intellectual property, in addition to preparation of articles for publication, style, terminology, measurement, and quantification. Now with an online component! The online subscription is activated by entering an access code number bound into the back of the book.Customers who purchase the Special Online Bundle Package receive the hardcover 10th edition, as well as a one-year subscription to the Online Edition.

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12/25/2011

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices Review

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
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written in a technically precise and easy-going manner, it covers well all items listed in the index. Allocation of tables and pictures sometimes far from the page one is reading, but no harm done. Overall it is an excellent book to align a team of RA professionals with the basics of the area.

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"This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." –Microbiology Today, May 2009
Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices.
Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.
The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

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12/10/2011

Using and Understanding Medical Statistics Review

Using and Understanding Medical Statistics
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For what this book intends, it truly is outstanding. In general, the medical researcher of any kind is at a severe disadvantage in dealing with professional biostatisticians because often the two do not speak a common language. This very readable, interesting and clearly written book gives the scientist enough knowledge to deal with most relatively simple cases in a language that we understand. With the basic principles of medical statistics made comprehensible, we are able to understand many of the simpler software packages well enough to perform basic statistical analyses and, more importantly, are able to converse intelligently with biostatistical professionals and to design studies that will pass muster. Unlike another reviewer, I do not feel that not covering SAS or other software programs is a disadvantage. No book can cover everything, and this book covers the basics and intermediate levels far better than any book I have seen, certainly better than any biostatistics book written by biostatisticians intended for other biostatisticians. This book understands that biostatistics is a tool, not a fundamental discipline, for the vast majority of scientists and is written to them. The book serves as a ready reference and review if one does not perform these analyses on a daily basis. This book should be on the shelf of every life scientist.

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11/18/2011

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition Review

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition
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Amazon lists a 2003 paperback as 2nd edition and this hardback 2008 as "second edition." This hardback 2008 is clearly a later edition although both are so called second editions. Maybe the other should be called first edition, or maybe the mere fact the other was a paper back printing triggers a not-very-accurate second edition logo.
Well done book. The earlier (2003/2005) edition is available on kindle but not the 2008.
BQ

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Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.FDA Regulatory Affairs:provides a blueprint to the FDA and drug, biologic, and medical device developmentoffers current, real-time information in a simple and concise formatcontains a chapter highlighting the new drug application (NDA) processdiscusses FDA inspection processes and enforcement optionsincludes contributions from experts at companies such as Millennium and Genzyme, leading CRO's such as PAREXEL and the Biologics Consulting Group, and the FDAThree all-new chapters cover:clinical trial exemptionsadvisory committeesprovisions for fast track

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