(Press-News.org) To help further secure a safe supply of the widely–used blood thinner heparin, a third round of revisions to quality standards for the drug has been advanced by the U.S. Pharmacopeial Convention (USP). USP's Expert Panel on Unfractionated Heparin ended a two-day meeting on May 16th, 2012, and recommended finalization of the proposed changes. The revisions are scheduled to appear in the November–December 2012 issue of Pharmacopeial Forum—USP's free-access, online publication for posting proposed standards and receiving public comments. The deadline for submitting comments on the revisions will be January 31, 2013. Thereafter, the proposed changes will be considered and finalized by the Expert Panel, followed by further consideration by the Council of Experts Monographs–Biologics and Biotechnology 1 Expert Committee. If acceptable to the Expert Committee, the final standards will appear in USP's compendia, United States Pharmacopoeia (37) and National Formulary (32).
"A secure and safe drug supply is something that the public has come to expect and rightfully so," said Roger L. Williams, M.D., USP's chief executive officer. "Quality standards play a significant role in the overall safety net of regulations and controls that protect medicines in the U.S. Developing and continuously improving standards based on the best science available are paramount."
In the 2007-8 time frame, over-sulfated chondroitin sulfate (OSCS) was associated with adverse effects and deaths among patients. Thereafter, the U.S. Food and Drug Administration (FDA) and USP began working with manufacturers on a multi-stage process to revise and modernize standards for heparin. OSCS is a less costly substance than heparin and was used for economically motivated adulteration because it can mimic heparin activity when using older, less-sensitive tests.
USP and its partners completed the first round of revisions to the heparin standards in June 2008. Those changes consisted of validating and implementing procedures to detect OSCS. Round two revisions to the standards were completed in October 2009 and included new Identification, Potency Assay, and Impurities (e.g., Absence of OSCS) procedures, with associated reference materials. Stage two also involved the harmonization of USP Heparin Units with International Units established by the World Health Organization.
The third and latest round of revisions to USP's heparin standards will bring even greater sensitivity and precision to the tests and reference materials used to help ensure heparin quality. In response to requests from the FDA, USP has identified and plans to incorporate into the standards new and improved procedures and tighter specifications for detecting and deterring the presence of OSCS as well as improved control for protein and nucleic acid impurities. FDA also requested the addition of a heparin molecular weight determination procedure, which will be included in the proposed revisions along with a related reference material.
Low molecular weight heparins, such as enoxaparin sodium, a newer class of anticoagulant drugs, result from further processing of Heparin Sodium. For this reason, standards for Heparin Sodium also impact those for low molecular weight heparins. USP's activities related to unfractionated heparin will be among the highlights of the Fifth Workshop on the Characterization of Heparin Products taking place on August 14-15, 2012, at USP's headquarters in Rockville, Md. Co-organizers of the event are the National Institute for Biological Standards and Control, the European Directorate for the Quality of Medicines and Healthcare and USP.
###
USP – Advancing Public Health Since 1820
The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are relied upon and used worldwide. For more information about USP visit http://www.usp.org.
END
Rockville, Md., May 23, 2012 — As part of its ongoing efforts to help ensure the quality of medicines, the U.S. Pharmacopeial Convention (USP) has announced two new standards related to elemental impurities: General Chapters Elemental Impurities—Limits and Elemental Impurities—Procedures. The new standards provide procedures for the detection of selected impurities in drug products based on modern analytical methods, as well as acceptable limits for their presence based on toxicity data and exposure levels. Conformance to the new standards will be required starting May ...
Initiating and maintaining nearshore production facilities will be the subject of two Mexico manufacturing events to be hosted this fall by The Offshore Group.
Manufacturing in Guadalajara 2012 will take place from September 18th - 20th at the Fiesta Americana Grand Hotel in the business-friendly city of Guadalajara, Jalisco. Attendees at the event will be introduced to the strategic and economic advantages that accrue to companies that choose to manufacture in what is one of Latin America's most vibrant, cosmopolitan and well-situated cities. Companies that locate in ...
(SACRAMENTO, Calif.) — A team of UC Davis researchers has found that mothers who had fevers during their pregnancies were more than twice as likely to have a child with autism or developmental delay than were mothers of typically developing children, and that taking medication to treat fever countered its effect.
"Our study provides strong evidence that controlling fevers while pregnant may be effective in modifying the risk of having a child with autism or developmental delay," said Ousseny Zerbo, lead author of the study, who was a Ph.D. candidate with UC Davis when ...
SS Choice, LLC, one of the leading electronic cigarette manufacturers since 2008, has renamed their company website My7s. The new website and blog have a new look and additional features designed to improve usability. Intuitive navigational tools, new fonts, and updated graphics and layouts will help users access information more quickly and easily. Feature sections on the secondary pages highlight new and frequently requested content.
The new website contains a comprehensive listing and directory of electronic cigarette related products. The website will be a tremendous ...
After five years of research in 35 different organizations and across 13 different industries, Dr. Timothy R. Clark and team announce the release of their highly anticipated book, The Employee Engagement Mindset.
The Employee Engagement Mindset represents a radical break from the traditional paradigm of employee engagement. The first question the authors asked was: "Who owns employee engagement?" More than half of the leaders surveyed said the organization does. But 100% of the highly engaged employees said they owned their own engagement. "This is an ...
The winter months have caused death to the American homeless in the past and one tarp company plans to lessen fatalities with tarps for hypothermia prevention. Tarps Plus has been a long-standing contributor for homeless causes and is planning to make 2012 its largest year.
The poly and vinyl tarps are used for covering up from rain and snow. The tarps help prevent hypothermia during the winter months. One tarp will be given out to each person at the shelter. Some clear tarps will also be given out for environmental reasons.
Tarps Plus has loaded up a massive inventory ...
POSitive Technology and Retail Hero partnered up to offer Microsoft Dynamics RMS customer Pictures Plus an unparalleled POS-integrated customer loyalty rewards system known as Hero Points.
Hero Points for Microsoft Dynamics RMS and POS2009 allows customers to collect loyalty points and redeem them for rewards where the store owner is given the capability to define both collection and redemption schedules and provide the bonus and welcome points and various accelerators. At the POS till during a transaction the system automatically prompts the cashier to reward the customer ...
Pregnant women, including those who are obese or overweight, should be encouraged to minimise weight gain through diet, according to major new research from Queen Mary, University of London.
Piling on excess weight during pregnancy increases the risk of complications for pregnant women but doctors have been cautious in advising women on ways to manage weight for fear of any adverse effect on mother or baby.
However, the new study published in the BMJ shows that following a healthy diet, overseen by health professionals, stems excess weight gain in pregnancy and reduces ...
Boulder, Colo., USA – Geosphere articles posted 17 May include an introduction to the new theme; a multifaceted study of the formation and transport of ancient oceanic rocks now found in southeastern Yukon, Canada; a new technique to help find the initial age of a multiply reactivated fault; and bathymetry studies of unusual flat-topped seafloor mounds beneath the Ross Sea that the authors believe are of volcanic origin, erupted during a geomagnetic reversal and under a grounded ice sheet.
Abstracts for these and other Geosphere papers are available at http://geosphere.gsapubs.org/. ...
A large survey of human genetic variation, published today in the online version of the journal Science, shows that rare genetic variants are not so rare after all and offers insights into human diseases.
"I knew there would be rare variation but had no idea there would be so much of it," said the senior author of the research, John Novembre, an assistant professor of ecology and evolutionary biology and of bioinformatics at UCLA.
A team of life scientists studied 202 genes in 14,002 people. The human genome contains some 3 billion base pairs; the scientists studied ...
