Live Presentation - Wednesday, June 13, 2012, 11:00 AM EDT Preventing Costly Out-of-Specification Investigations

Out-of-Specification (OOS) investigations in Analytical R&D and QA/QC laboratories are costly and time-consuming. Although analytical instrumentation has seen impressive innovations in speed and efficiency over the last 10 years, sample preparation techniques have remained virtually unchanged for the past 75 years. Sample preparation is now reported to be the most time-consuming, labor-intensive and error-prone part of the workflow, with some 50% of OOS errors attributed to either preparation steps or operator error. These OOS errors could be prevented by automation.
This Webinar is dedicated to improving the sample preparation process in terms of efficiency and reliability:

• Learn how to tackle 50% of the sources of error that cause costly OOS results and investigations.
• Learn how to prepare samples and standards more efficiently and reduce the time and number of steps by a factor of three.
• Learn how to reduce the variability of your results whilst down-scaling the substance and solvent consumption by up to 90%.

Dr. Charles Ray will share over 15 years’ experience in managing Analytical R&D workflows in leading pharmaceutical companies, such as Bristol-Myers Squibb Co, and also describe the challenges faced in his laboratory. Klaus Fritsch and Joanne Ratcliff, weighing and sample preparation experts from METTLER TOLEDO, will introduce the latest innovations and technology to cope with these challenges, including Good Weighing Practice and automated weighing/data management. All speakers will be available for a Q&A session.

For more info: https://event.on24.com/eventRegistration/EventLobbyServlet?target=registration.jsp&eventid=457614&sessionid=1&key=87F94293F0BF8CC040B3E367466FD9DA&sourcepage=register

Cell Culture Best Practices & Tips for Improving Your Culture Outcomes

Featuring Timothy Fawcett, Ph.D. Director, BioTechnical Institute of Maryland.

Webinar agenda:

• The in-vitro system and factors affecting cell culture
• Components & formulations of media; performance characteristics of serum
• Cell culture productivity and interrelationship between cell growth cycle & its environment
• Tips & techniques for maximizing recovery

Gibco® cell culture products are infused with quality, customer-focused innovation, and service excellence from beginning to end. From the most basic formulations to the newest innovations, Gibco® products always provide the highest quality, consistency, and performance—for results you can count on every day.

Presenter Bio

Timothy Fawcett, PhD is currently the Director of the BioTechnical Institute of Maryland, in Baltimore MD, USA. He is also an Adjunct Faculty at Johns Hopkins University. Dr. Fawcett was a Senior Scientist at a major International biotech company and a Senior Staff Fellow at the National Institutes of Health, Institute on Aging. Tim has a deep knowledge of biotechnology and has served as a consultant in the industry and government for over 20 years.

Countess™ Automated Cell Counter Raffle Prize!

Complete your registration and participate in this popular on-demand webinar by June 15, 2012 to be entered into a raffle prize draw*! You could be the lucky winner of a Countess™ Automated Cell Counter for your lab – fast, easy & accurate cell counting and more!!

*Terms & conditions apply. No purchase necessary. Participation is open only to life science researchers 18 years or older in the US and Canada (excluding Quebec). To enter the sweepstakes, register for and view the 1-hour, on-demand webinar entitled “Cell Culture Best Practices & Tips for Improving Your Culture Outcomes.” Registration forms must be received no later than June 15, 2012, at 11:00 p.m. ET.

Click here for complete terms & conditions.

Source: www.lifetechnologies.com

More Info: http://find.lifetechnologies.com/gibco/mythbusterswebinar/fbads/welcome-1565H4-2036UC.html

Chemotherapy

More information on chemotherapy at http://www.cancerquest.org/chemotherapy-introduction.
Introduces chemotherapy and explains the purpose of chemotherapy. Explains how chemotherapy is administered to patients and the type of side effects that the chemotherapy can bring about.
For more information, visit CancerQuest at http://www.CancerQuest.org/.

Published by: CancerQuest

World No Tobacco Day 2012 - global event Geneva

A high-energy performance from local dance group, Know the Ledge, concludes World No Tobacco Day celebrations at WHO's headquarters in Geneva, Switzerland. A dozen young dancers give a unique interpretation of the battle between the tobacco industry and all those trying to prevent the 6 million deaths caused by tobacco every year.
For more information:
http://www.who.int/tobacco

FDA approves generic versions of blood thinner Plavix

 

The U.S. Food and Drug Administration today approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.

Clopidogrel is FDA-approved to treat patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery (peripheral artery disease).

“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “The generic products approved today will expand those options for patients.”

Clopidogrel has a boxed warning to alert health care professionals and patients that the drug may not work well for those with certain genetic factors that affect how the body metabolizes the drug. Patients can be tested for these genetic factors to ensure that clopidogrel is the right choice for them. Also, certain medicines, such as proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), reduce the effect of clopidogrel, leaving a person at greater risk for heart attack and stroke.

Clopidogrel may cause bleeding, which can be serious and sometimes lead to death. While taking the drug, people may bruise and bleed more easily, be more likely to have nose bleeds, and it may take longer for all bleeding to stop. Clopidogrel is dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.

Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals have gained FDA approval for 300 milligram (mg) clopidogrel. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel.

Generic drugs approved by FDA are of the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs.

Information about the availability of generic clopidogrel can be obtained from the manufacturers.

For more information:

FDA: Understanding Generic Drugs

Source: FDA

WHO: Stop tobacco industry interference

Tobacco is public health enemy number one. It kills six million people every year. The tobacco industry does everything it can to undermine anti-tobacco work. WHO has chosen "Stop tobacco industry interference" as the theme for the 2012 World No Tobacco Day - on 31 May. Discover the subversive methods of the tobacco industry by watching the campaign video. Find out what WHO, governments and civil society are doing, and how you can help stop the tobacco industry in its tracks, by joining the conversation on Twitter @WHO - #NoTobacco. (http://twitter.com/#!/who)

Published by who

Indoor Tanning: The Risks of Ultraviolet Rays

Theres no such thing as a safe tan. Regardless of the source, UV rays pose a health risk. Learn more at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm186687.htm

Published by: USFoodandDrugAdmin

DIA 2012 Annual Meeting: Collaborate to Innovate

DIA 2012 is the premier global event that brings together more than 8,000 global professionals who are involved in every aspect of the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products.

Published by: DrugInfoAssoc

Generics, Pseudo-Generics and the Race for Consumer Dollars

 

Author: Saaqshi Sharma

The release of pseudo-generics or ‘fake’ generic drugs is common practice in Canada. This allows drug developers to maintain market share over a niche market of drug consumers, but also challenges generic companies’ ability to compete in the industry.

According to Health Canada Regulations, generic drugs have the same active pharmaceutical ingredients (APIs) and therapeutic effects as the corresponding brand name drugs, and differ only in their non-medicinal ingredients (aka excipients). Generic drugs sell at a fraction of the price of brand name drugs because they do not bear the extreme financial burden of extensive research and development phases, clinical trials, and brand marketing.

Generic drugs were first implemented following the Hatch-Waxman Act in 1984 which allowed generic drug manufactures to produce drug products with less fear of litigation from the drug’s innovators. This can only take place after the drug patent for the active ingredients has expired. Since the drug development process can take over 15 years from the original idea to the final drug product, drugs that have been approved by Health Canada and the FDA are awarded a 20 year patent that provides the manufacturer exclusive rights to sell the drug. This gives the innovator time to have sole marketing rights to their product, referred to as market exclusivity, and hopefully make back some of the money they have spent over the phases of research and development before other companies can enter the market with a generic version. When a drug patent expires all other companies are free to produce their own generic versions.

Patents can be extended when new uses for the drug are presented. Drug companies often scramble to find such indications so that they can extend their patent life and as a result be the sole providers of the drug for a longer amount of time. Competing companies similarly move quickly to release generic versions of drugs with closing patents in order capitalize on consumers looking for generic alternatives. In another attempt to maintain their market exclusivity, manufacturers of the brand name drug will release pseudo-generics which are identical to the brand name drug and manufactured on the same production line, but marketed and sold under a different name. Basically it is a ‘generic drug’ that is being produced by the brand name company.

This way, manufacturers can move quickly to infiltrate the generic drug market with little to no competition before the actual generic companies even have time to produce their products. This is beneficial for consumers who can get the same drug for 20-90% of its original cost. On the other hand, it is discouraging for competing generic companies because the market is already saturated with both the brand name drug and the pseudo-generic drugs, both made by the same company.

As a result there is a divide between innovation and competition. Innovator drug companies strive to maintain their market share and recoup costs associated with the development process; and generic companies fight to remain competitive in the industry.

 

Credits: Saaqshi Sharma  Canadian Centre for Clinical Trials