Monthly Archives: January 2014

Are enough women included in medical device studies, as required by the FDA?

Posted: January 24, 2014 at 2:43 am

PUBLIC RELEASE DATE:

23-Jan-2014

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, January 23, 2013-The U.S. Food and Drug Administration (FDA) mandates adequate enrollment of women in post-approval studies (PAS) of medical devices to ensure that any sex differences in device safety and effectiveness are not overlooked. A group of authors from the FDA report the results of a study evaluating the participation of women and analysis of sex differences in PAS in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Women's Health website.

Women may respond differently to medical devices due to factors such as genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal or environmental factors. They may face greater or lesser risk of adverse events or derive more or less benefit. "Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews," state the authors in their article "Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration."

"It is critically important that we have adequate participation of women in clinical trials, and that we analyze sex differences in study outcomes and adverse events," says Editor-in-Chief Susan G. Kornstein, MD, Executive Director of the Virginia Commonwealth University Institute for Women's Health, Richmond, VA, and President of the Academy of Women's Health.

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About the Journal

Journal of Women's Health, published monthly, is a core multidisciplinary journal dedicated to the diseases and conditions that hold greater risk for or are more prevalent among women, as well as diseases that present differently in women. The Journal covers the latest advances and clinical applications of new diagnostic procedures and therapeutic protocols for the prevention and management of women's healthcare issues. Complete tables of content and a sample issue may be viewed on the Journal of Women's Health website. Journal of Women's Health is the Official Journal of the Academy of Women's Health and the Society for Women's Health Research.

About the Academy

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Are enough women included in medical device studies, as required by the FDA?

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Looking for a ‘superhabitable’ world? Try Alpha Centauri B, says Astrobiology Journal

Posted: at 2:43 am

PUBLIC RELEASE DATE:

23-Jan-2014

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, January 23, 2014The search for extraterrestrial life extends far beyond Earth's solar system, looking for planets or moons outside the "stellar habitable zone" that may have environments even more favorable to supporting life than here on Earth. These superhabitable worlds have unique characteristics and are ideal targets for extrasolar exploration, as described in a provocative Hypothesis Article in Astrobiology, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the Astrobiology website.

In "Superhabitable Worlds" Ren Heller, McMaster University (Hamilton, Ontario, Canada) and John Armstrong, Weber State University (Ogden, UT), propose how tidal heating can create conditions in which life could emerge on an icy or terrestrial planet or moon once thought to be uninhabitable.

"A great place for hydrothermal microorganisms and a volcanic eruption in the weather forecast every morning and evening," says Norman Sleep, Senior Editor for Astrobiology and Professor in the School of Earth Sciences at Stanford University, "a tidally heated planet would be unpleasant though spectacular to visit."

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About the Journal

Astrobiology, led by Editor-in-Chief Sherry L. Cady, Chief Scientist at the Pacific Northwest National Laboratory, and a prominent international editorial board comprised of esteemed scientists in the field, is the authoritative resource for the most up-to-date information and perspectives on exciting new research findings and discoveries emanating from interplanetary exploration and terrestrial field and laboratory research programs. The Journal is published monthly online with Open Access options and in print, and is the Official Journal of the Astrobiology Society. Complete tables of content and a sample issue may be viewed on the Astrobiology website.

About the Publisher

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Looking for a 'superhabitable' world? Try Alpha Centauri B, says Astrobiology Journal

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Ethics of Pharmacogenomics – Video

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Ethics of Pharmacogenomics
Wylie Burke, M.D., PhD. is chair of the Department of Bioethics and Humanities at the University of Washington and an adjunct professor of medicine and epide...

By: Mayo Clinic

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Ethics of Pharmacogenomics - Video

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How Old Is Adam? Scientists Claim Earliest Male Ancestor Emerged 209,000 Years Ago

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According to a new study, published in the European Journal of Human Genetics, the most recent common male ancestor to humans existed 209,000 years ago 9,000 years earlier than scientists had previously thought. The findings place the earliest female ancestor, "Eve," within the same timeframe as her male counterpart.

"We can say with some certainty that modern humans emerged in Africa a little over 200,000 years ago," Eran Elhaik of the University of Sheffield said in a statement.

The latest findings contradict a recent study that suggested Adam was twice as old as Eve on the basis that the Y chromosome originated in a different species through interbreeding. They also debunked a separate study that said the discovery of the Y chromosome predated humanity.

"We have shown that the University of Arizona study lacks any scientific merit. In fact, their hypothesis creates a sort of 'space-time paradox,' whereby the most ancient individual belonging to Homo sapiens species has not yet been born, Elhaik said. "Think of the movie 'Back to the Future,' when Marty was worried that his parents would not meet and as a result he wouldnt be born -- its the same idea.

The latest research used conventional biological models to date the most common male ancestor. The research team calculated the age of the Y chromosome by multiplying data on the average age fathers have their first child with the number of mutations they found. This number was then divided by the mutation rate of the Y chromosome.

Of course, we can manipulate each one of these variables to make a finding look younger or older, Elhaik told The Daily Mail. In our paper, we showed the previous study manipulated all these variables to predate the Y chromosome.

While the study challenges other conclusions, it raises more questions concerning the behavior of ancient humans.

"It is obvious that modern humans did not interbreed with hominins living over 500,000 years ago. It is also clear that there was no single 'Adam' and 'Eve' but rather groups of 'Adams' and 'Eves' living side by side and wandering together in our world, Elhaik said. The question to what extent did our human forbearers interbreed with their closest relatives is one of the hottest questions in anthropology that remains open.

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How Old Is Adam? Scientists Claim Earliest Male Ancestor Emerged 209,000 Years Ago

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The TINY Vaporshark DNA mod (DNA 20) – Video

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The TINY Vaporshark DNA mod (DNA 20)
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The TINY Vaporshark DNA mod (DNA 20) - Video

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DNA – WHBC Radio Freestyle – Video

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DNA - WHBC Radio Freestyle
Howard Hottest Artist, D.Derek Alex King freestyle on WHBC before the competition thednasound.tumblr.com twitter.com/TheDnasound facebook.com/thednasound.

By: D.Derek Alex King

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DNA - WHBC Radio Freestyle - Video

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An Introduction to DNA Microarrays – Video

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An Introduction to DNA Microarrays
This presentation is a brief overview of DNA microarrys - what are they and how are they used. This is the first of three presentations on DNA microarrays. T...

By: SW Center for Microsystems Education .

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An Introduction to DNA Microarrays - Video

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I got my DNA results in part 2 – Video

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I got my DNA results in part 2
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I got my DNA results in part 2 - Video

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Buyer Beware Ancestry DNA Scam – Video

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Buyer Beware Ancestry DNA Scam
Exposed DNA hoax.

By: SuperLuminous1

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Buyer Beware Ancestry DNA Scam - Video

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SWTOR Fungus Harvester-Champion: Rakghoul DNA Drop – Video

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SWTOR Fungus Harvester-Champion: Rakghoul DNA Drop
SWTOR Alderaan Daily Area: Rakghoul Champion - Fungus Harvester Play SWTOR for Free: http://play.any.tv/SHGn6 Support the Creators, Don #39;t Block Ads! Pa...

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SWTOR Fungus Harvester-Champion: Rakghoul DNA Drop - Video

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