The impact of influenza can only be reduced through a vaccine.  Today, the U.S. has only approved the use of inactivated influenza virus vaccines, and to be effective, these have to contain an H1N1, and H3N2, and a B virus component.  In the past, at least one of these components had to be modified due to antigenic drift of the strain circulating the human population.

Vaccines are prepared by growing viral strains in embryonated eggs, and then the virus is purified and turned noninfectious through chemical inactivation.  The influenza vaccines available today are effective depending on the antigenic ‘match’ of the circulating viruses with the strains used for vaccination, the person’s age, and his or her immune status.

Here’s what is expected in the future; ask your pharmaceutical consultant for further details:

1.    Cold-adapted influenza virus vaccine
This type of live vaccine has been used successfully in Russia to protect millions of children.  The U.S. has been trying to develop such a vaccine for over 20 years, but the license has not been approved yet.

There are several important advantages here:

-    Live-virus vaccines can be administered through nasal spray, which is easier and less costly than the intramuscular option.

-    These can induce local neutralizing immunity and cell mediated immune responses, which could result in a longer-lasting and better cross-protective immunity.

-    Overall protection may improve for certain age groups, for example, kids 6 months to 9 years of age, with evidence of a massive reduction in secondary bacterial infections causing otitis media.

The more live influenza virus vaccines are used, the more benefits, risks, and economic consequences of this approach will be known.

2.    Genetically engineered live influenza virus vaccines
The introduction of techniques to engineer site-specific changes in the genomes of negative-strand RNA viruses has allowed the consideration of new vaccine approaches.  It is possible now to create strains with unique properties that lead to reduction.

3.    Live influenza virus vaccine candidates expressing altered NS1 genes
Now it is possible to rescue influenza virus vaccine candidates from cells transfected with plasmids.  This allows for the engineering of deletions in genomes of influenza viruses for better stability.

4.    Use of replication-defective influenza viruses as vaccine candidates
This is a promising approach, the construction of virus particles that undergo only a single cycle of replication.  These induce a protective antibody response and stimulate a strong cell-mediated immune response without allowing the replication of infectious virus.

5.    DNA vaccination
This involves the administration of plasmid DNA encoding one or more of the influenza virus proteins.  Studies have been limited to animal samples with very promising results; however, this type of vaccine may be better for diseases like AIDS.  Further studies may present a universal approach to generating protective humoral and cell-mediated responses to different foreign antigens, resulting in the development of effective vaccines.

6.    New adjuvant approaches
Current influenza virus vaccines are administered by intramuscular injection.  To improve their immunogenicity, liposome-like preparations have been developed, which contain cholesterol and viral particles that are very effective in mice when delivered subcutaneously or in intranasal form.  More tests are needed to confirm how it will work in humans.

7.    Universal vaccine
This has been the focus of increased attention due to the current necessity to develop a new vaccine every year given the influenza virus’ continuous antigenic change.  Even though some virus components are more conserved than others, a good approach to a universal vaccine based on these conserved elements is still pending, because these are minor antigens, and thus, are less immunogenic and less likely to create a protective response.

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Laboratory personnel are exposed to a high risk of injury due to repetitive movements during normal lab procedures like pipetting, microscope use, operating microtomes, using cell counters and video display terminals.  This type of injury develops with time and it happens when the muscles and joints are stressed, tendons are swollen, nerves are pinched, and blood flow is restricted.  Another health risk for lab workers comes with standing and working in uncomfortable positions in lab hoods and biological safety cabinets.

Here we show you several ways to control some of these risk factors and to ensure your personnel is working in a comfortable, productive, and safe lab environment.

1.    Pipetting
This task involves various ergonomic strains like thumb force, repetitive movements, and awkward postures of the wrists, arms, and shoulders.  In order to alleviate these hazards follow these tips:

-    Use pipettes that fit comfortably in the user’s hand and that have triggers that need less force to be activated. Also, aspirate with the pointer finger and dispense with the thumb.

-    Use an electric pipette with mixing function to mix and aliquot, and use multichannel pipettors for big aliquot jobs.

-    Use shorter pipettes that decrease hand elevation.

-    Use low profile waste containers for used tips.

-    Take 3-5 minute breaks for every 20-30 minutes of pipetting, exercise and stretch your hands and arms while resting.

-    Clean pipetters regularly.

-    Adjust the workstation so that the employee can work with arms close to the body.

-    Rotate pipetting with other lab tasks and people.

-    Use thin wall pipette tips that fit correctly and eject easily, and use minimal force when applying them.

-    Maintain samples and instruments within easy reach.

-    Use an adjustable chair when sitting at a lab bench.

-    Use anti-fatigue mats when you need to stand for an extended period while pipetting.

2.    Computer workstation
Some researchers spend long hours entering data with a keyboard and mouse over a very high bench, making the person elevate the arms excessively.  This is what you need to do:

-    Install adjustable keyboard trays under the benches, and monitors at viewing distance between 18 and 30″ and with top of screen at eye level.

-    Locate computers away from doors, entrances, and passageways.

-    Use adjustable seating.

-    Hold documents adjacent to and in the same plane as the screen.

-    Install foot rests.

-    Offer different keyboards and mouse attachments for personnel with muscle problems.

-    Order 2-5 minute breaks for every 20-30 minutes of computer use.

-    Do not go from keyboarding to pipetting or vice versa without resting at least 15 minutes.

3.    Microscopy
Microscopy workstations must be adjustable to fit every size of person:

-    Don’t use a microscope for more than 5 hours per day.

-    Locate the microscope on the edge of the table to achieve an upright position.

-    Use a cut-out work table.

-    Elevate the microscope and place it at an angle at which you can look directly into the eyepiece.

-    Keep neutral spine.

-    Give arm rests for while using the adjustment knobs.

-    Use an ergonomic chair with good back support.

-    Ensure there is enough room under the table so that the person can pull the chair up to the ocular.

-    Install footrests and avoid foot rings on stools.

-    Provide sit-stand seats for areas with little leg room.

-    Order regular breaks.

-    Use television systems instead of binocular eyepieces.

4.    Overhead Lifting
Lack of space can force you to store equipment and supplies on overhead shelves, if this is so, follow these tips:

-    Store heavy objects on lower shelves.

-    Use a stable stool or ladder to reach overhead shelves.

-    Do not twist while you lift.

-    Use rotating carrousels to store materials close to the worker.

The well being of personnel is vital for the good functioning of any laboratory.  Any pharmaceutical consultant will agree that people are a pharmaceutical company’s strongest asset; by caring for their health you are taking your company far ahead in the market.

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This is the drug manufacturer’s nightmare: the phone rings and an FDA official announces an upcoming inspection.  Even though they are clearly necessary, FDA inspections are a weight on pharmaceutical companies’ shoulders.  Without these inspections, pharma companies cannot keep the FDA’s approval to sell their products.

It is the FDA’s duty to call in advance to announce an inspection, its purpose, duration, and number of people involved.  On inspection day, the FDA official will ask to see the top management person on site, and he will show his credentials and an FDA ‘Notice of Inspection’ to that person.  Afterwards, a thorough inspection of the facilities will begin, while one or more key employees tag along.  After a few days, the FDA will send an ‘Inspectional Observations form’ to the leadership team informing them about any unacceptable conditions they have found in regards to products, processes, or other violations to the FD&C Act.

The results of such an inspection can range from no needed actions to a complete closing of the facilities and administrative, civil, or criminal actions against the company.  Normally, the FDA will recommend actions to improve operations in line with the FD&C Act.

Given the serious nature of this process, it is necessary to plan ahead and be ready for the eventual call.  Here are 5 tips to welcome the FDA with a smile on your face:

1.    Implement regular internal FD&C Act compliance training
The best way to ensure a successful FDA inspection is to ensure the facility complies with FDA regulations.  Every employee must be aware of the products and processes’ FDA standards for the area he or she tends to.  Employees have to be trained to stay calm, be respectful, and follow the FDA official’s requests, as well as to know their rights about what they have, or not have, to say or show the FDA.

2.    Identify and work on weaknesses
Smart professionals work on identifying the weaknesses that could attract the FDA’s attention before this happens.  Some examples are potential contamination, under maintenance, and unclean areas.

3. Select key people to accompany the FDA official
Train two or more employees who supervise the major processes to follow the FDA official.  Teach them how to treat and interact with this person.

4.    Write an operations manual
Operations manuals should be the main reference in the facility.  Employees must have continuous access to them in order to check actions and steps to maintain FDA compliance at all times within their areas.  This provides education and encouragement to go through any inspection with confidence.

5.    Make regular FDA compliance checks
Don’t wait until the FDA is there to identify the problem areas, identify them yourself and work with your personnel to fix them.  This will give your people confidence because they know what they are dealing with and they know how to solve it.

FDA inspections are normally not happily welcomed because they require a lot of additional resources and energy, however, every pharmaceutical consultant will tell you that being prepared is not only the best way to pass the inspection, but also to get your business under control and avoid worrying about what is out of your hands.

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As the Global economy continues to deteriorate in many parts of the world, the same can’t be said about the booming pharmaceutical industry.  According to researchandmarkets.com the global pharmaceutical market is expected to earn well over one trillion dollars in revenues by the end of 2011.  This forecast is based on many growing trends, which seem to not be affected by the global economic crisis of the past few years.  Some of these trends include the growth of developing pharmaceutical markets in emerging markets, strong growth in bio-tech based drugs, as well as a large increase in the prevalence of generic medicine.  But what other factors are contributing to this large boost in the pharmaceutical sector?

Some of the key research findings researchandmarkets.com found in their report are very conclusive.  With a Compound Annual Growth Rate (CAGR) growing at almost 8% per year, the pharmaceutical industry is one of the fastest growing industries in the global marketplace.  If the CAGR continues to grow at this pace, the global pharmaceutical market is expected to reach upwards to 1045 Billion in 2012.  Other research findings tell the same story.  The report also credits the growth in previously untapped markets, the Asia Pacific market like India and China, as being one of the most lucrative pharmaceutical markets of the future.  The report also credits the recent growth in Latin American markets, such as Mexico and Brazil, as being key players in the pharmaceutical industry, over the next 20 years.

Many pharmaceutical consulting firms are suggesting many other global trends that are factoring into this large boost in the pharmaceutical industry.  Some of these factors include growing market size, favorable government policies, expanding health coverage, and new developments in drug developing technology, just to name a few.  However, not everyone in the industry is convinced this unprecedented growth will sustain itself for much longer.

Many life sciences consulting firms are pointing out, that as patents held to key drugs begin to expire in the next ten years, it could hurt the growth of the North American pharmaceutical market.  Coupled with the growing prevalence of generic drugs all over the world, as well as dwindling drug pipelines, and the development of less blockbuster drugs and less and less economic cooperation, these factors may challenge the growth of the global marketplace in times to come.  Only time will tell.

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No matter what happens with the biosimilar legislation, patent holders will have to go through their patent files carefully.

The current generic drug industry was born from the Hatch-Waxman Act of 1984.  Among its creations, this Act accounts for a specialized form of patent litigation called Abbreviated New Drug Application (ANDA) litigation.  The Act defined an abbreviated approval process for small molecule drugs’ generics; however, it didn’t establish a structure for approving follow-on biologics, known as biosimilars and generic biologics.  The US Congress is now studying legislation to create such a structure.  If this legislation is ratified, it will most probably create a patent litigation structure very different from the ANDA form.

Through modern technologies, biologic drugs are isolated from living matter or produced in living cells.  Biologics vary from small molecule drugs in various ways related to safety and product variability, aspects that are critical for the definition of an approval process for follow-on biologics:

-    They are large and complex molecules or mixes of molecules.
-    They are produced in living cells, offering great potential for greater variability based on the precise host cells or organisms used to create them, the growth conditions for culturing them, and the purification methods employed to isolate the biologic from contaminants.
-    They show distinctive safety issues, like the possibility of producing negative immune responses.

Biologics are so complex and variable that it is difficult to define an approval process.  These characteristics prevent the implementation of a therapeutic equivalence standard similar to the one used for small molecule generic drugs in the Hatch-Waxman Act.  As an alternative, the standards of biosimilarity and interchangeability in HR 1427 and HR 1548 are proposed.

HR 1427 defines biosimilar as “no clinically meaningful difference between the biological product and the reference product would be expected in terms of safety, purity, and potency if treatment were to be initiated with the biological product instead of the reference product”.  HR 1548 requires that a follow-on biologic candidate exhibits biosimilarity “based upon data derived from: analytical studies that demonstrate that the biological product is highly similar to the reference product, from animal studies, and from clinical studies that are sufficient to demonstrate safety, purity and potency”.

In regards to interchangeability, both HR’s agree in that the biological product should be biosimilar to the reference one, and that the patient should go from one to the other without risk.

The similarity standards proposed pose new issues for patent litigations because there is no requirement that the follow-on biologic should be identical to the reference product.  Follow-on biologic candidates can say that their biologic doesn’t infringe any patents covering the reference product or its manufacturing process, and generic manufacturers may obtain approval on the basis of biosimilarity or interchangeability: it gives the same results but is different enough.  In addition, the manufacturer will probably try to make the product in a different way from the patented process, creating concerns about the follow-on biologic not being truly biosimilar or interchangeable.  It will certainly be a challenge for the reference product manufacturer to protect its investment.

In chain reaction, these possibilities will increase litigation costs, due to testing and characterization of the biologics, inspections of sites, and declarations of those involved.  There will be lots of pharmaceutical consulting for sure.

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Work can be a stressful place, and in the right kind of stressful environment, it can almost be unbearable, especially if you have a monotonous, sometimes tedious job, where you perform the same repetitive functions over and over.  These kinds of jobs like assembly line work, laboratory managers, or production supervisor positions, just to name a few, can create such anxiety for employees that they might feel there is no escape.  However, there are a number of exercises and other techniques you can do at work, to feel less stressed and more productive, as well as happier in the workplace.

Stress can be a devastating mechanism if left too long unchecked.  However stress can sometimes be a good thing.  It can motivate us and help to make us more prepared, more focused.  However, too much stress can be devastating to the body, as well as make us irritable, irrational, and can literally kill us if left unchecked for too long.  But taking a different approach to stress, and trying different techniques at work to deal with stress, can make all the difference in your physical and mental health.  Larger companies all over the world, as well as companies in the Fortune 500 and pharmaceutical industry often recommend workshops and seminars for their employees to reduce stress levels at work.  There are even consulting firms, like life sciences consulting firms for example, who can actually teach companies what to do to create a less stressful work environment.

One of these techniques is to improve your organization and time management skills.  This means to make your workplace as tidy and organized as you possibly can.  Too much clutter on your desk, or in your office, only increases stress levels, and leads to less productivity.  Create a system so you can keep your workplace organized, and it will pay dividends down the road.  Also learn how to take deep breaths throughout the day.  By just taking deep controlled breaths for simply 5 minutes before, during, or even after work, when feeling overwhelmed or stressed, can have a profound impact on your state of mental health, as well as reduce stress.  By practicing these deep, slow breaths at work, you can replenish your body’s oxygen supply, which will lead to more energy and better state of calm and mental preparedness.

It is also a good idea to take more small breaks at during the day.  By taking a 5 minute break at different intervals throughout the day, can work to break up the monotony of work and reduce stress levels.  You can go for a short walk outside, or just get away from your office for awhile, anything you can do to get your mind, and your body, doing something other than work.  There are also small things you can do to improve your stress levels at work.  You could get more sleep, surround yourself with more positive people, or even just learn to listen better.  Oftentimes you may feel stressed at work because you don’t understand your assignments clearly, but if you learn to listen better, and more thoroughly, you will be able to drastically reduce the confusion that leads to stress.  Stress can be a killer, but if you learn to deal with it properly, it can be one of your greatest strengths.

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With the health care debate raging in the United States, many experts have already forecasted many possible scenarios for what could be the end result, but are they accurate? As lawmakers continue to wrestle over such issues as the public option, and extending coverage to the uninsured, there is no debate that the government is looking to cut costs in the health care system, which could spell trouble for the pharmaceutical industry.  The pharmaceutical industry knows that with health-care reform on the way, the prescription drugs industry will be the first to get the axe, losing major pricing power, especially in the Medicare market.  While it is still up in the air whether a public option will pass, the pharmaceutical industry knows that a strong government controlled pricing plan spells big problems for the industry.

Even though the pharmaceutical industry has reason to be concerned, according to some pharmaceutical sales consultants all over the country, health care reform is not all bad news.  Because of the 46 million uninsured U.S. citizens likely to get some form of health care in the next 5 years, that equates for big profits for the pharmaceutical industry.  With more insured Americans getting more access for branded and generic prescription drugs, this will only mean more business for drug makers and a boost in demand.  But the pharmaceutical industry is not so convinced.  Because half of large drug company sales come from overseas, they see this boost as being inconsequential to the money they are going to lose on the federal price gauging that is likely to take place.

Here are some possible health care scenarios, some which may be good for the pharmaceutical industry, some which could even be disastrous.  One scenario is that the government will use its buying power, through Medicare programs, to demand lower drug prices from the pharmaceutical industry.  This program could lower the drug prices in Medicare up to 15%, with the burden of cost falling directly on the pharmaceutical companies.  However, with Medicare only representing about 20% of drug spending in the United States, and roughly half that world-wide, it would only amount to about a 2% decrease in the cost of pharmaceutical drugs.  However, this is not the only scenario.  Some expect that with the increase in coverage from formally uninsured citizens, the government will demand Medicaid pricing for this group, possibly slashing prices of U.S. drugs up to 10%.

Even though the pharmaceutical companies support health care reform, they may not be eagerly supporting a nationalized health care plan.  A nationalized plan, although unlikely at this point, could cut prescription drugs up to 15% even to 30% if the national plan offers very little choice for consumers.  Under this worst case scenario for the pharmaceutical industry, they could see their stock values fall up to 40%.  Any pharmaceutical consultant will tell you this scenario is unlikely, but it is speculations like these that fuel the passion and uncertainty that has become the health care reform debate.  Only time well tell.

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Environmental monitoring can play a vital scientific role in not only the long term, but also the short term growth of your pharmaceutical business.  Through knowledge and understanding you’ll be better equipped to avoid potential environmental violations, potential contamination problems, not to mention offer key ecological management and research.  Environmental monitoring is essential to any pharmaceutical company to determine the correct environmental planning and policy for business.  However, the benefits of environmental monitoring are not always clear, and it has been criticized in the past for being too costly, without enough justifiable upside.  So is environmental monitoring really vital to the Ecosystem Management of your business?

The answer is yes, and the results speak for themselves.  Environmental monitoring is critical in determining the safeness, and cleanliness of certain controlled environments, in the drug making and biotechnology industries.  Large pharmaceutical companies often hire outside pharmaceutical consulting firms, who specialize in environmental monitoring services, to conduct a thorough examination of their premises and all of their manufacturing components.  This enables quality assurance that the pharmaceutical company can move ahead unhindered, without any fear of contamination or ecological violations.  The pharmaceutical consulting firm will thoroughly inspect the entire manufacturing and production environment, to make sure everything is up to code, and safe, not only for the employees but the consumers as well.  Environmental monitoring is vital in guaranteeing the manufacture and control of sterile and non-sterile products within your entire manufacturing area.

Without environmental monitoring, many pharmaceutical companies would not be able to guarantee the safety and optimum efficiency needed in the mass production of pharmaceuticals.  Environmental monitoring is also important because it is the fundamental base for science-based initiatives, and adaptive management within a pharmaceutical company.  It helps to determine if a certain ecological project is having its intended results, as well as being safe and responsible.  By detecting any minor or major problems early enough in the production process, your pharmaceutical company could save possibly millions of dollars in losses, as well as any legal problems that may arise.

For environmental monitoring to be effective for your business, it should be carefully considered against your budget constraints, as well as the size and risk of your project.  If your project may be high risk, then having an environmental monitoring firm do a thorough examination may be costly at first, but could save your company millions down the road.  Sometimes, without the right monitoring at the very beginning of a project, you could spend years, and large amounts of money on a project that was doomed to fail from the beginning.  Environmental monitoring should be cost effective to your business, and should only be a small portion of the cost of the entire project.

Environmental monitoring can be a very important service in any pharmaceutical process. Any pharmaceutical consultant would agree that it may lead your business to a substantial reduction in the uncertainty that goes along with Ecosystem management, as well as guarantee the safety of possibly thousands of workers and potential customers.

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Many arguments have been made both for and against pharmaceutical outsourcing in the pursuit of achieving some sort of competitive advantage.  By allowing outside firms to concentrate on specific tasks, many pharmaceutical firms feel they can increase not only their performance, but deliver a better product in the end.  Too much outsourcing may have some negative effects as well.  Too much outsourcing may reduce organizational innovation within the company; it may shift certain knowledge to supplier organizations which may reduce the overall activity of the larger company.  However, pharmaceutical companies for years have worked hand in hand with a pharmaceutical consultant to develop a safer and more effective product.

Pharmaceutical companies all over the world are increasingly turning to outsourcing in an attempt to increase their overall productivity and competitiveness.  Large pharmaceutical firms are turning to smaller more specific firms to help them break through to the next level of improvement and innovation.  In order to meet the ever evolving market demands of the 21st century large pharmaceutical companies are being forced to improve the way they operate, based on innovation and efficiency.  Outsourcing for these large companies can have many advantages, but there are many barriers in the process.

One of these barriers to the global conflagration of outsourcing efficiency is that most outsourcing services are very specific to only one or two jobs.  Usually these smaller companies have very limited capabilities which means the larger companies have to look to more and more outsourcing firms to fulfill their outsourcing needs.  This makes the manufacturing process even more confusing not to mention costly.  Because of this fragmented market it can be difficult for larger pharmaceutical companies to achieve the kind of maximum efficiency they’re looking for.  That is why many pharmaceutical companies have turned to pharmaceutical consulting firms who can advise the best plans for the company to achieve the most innovation and efficiency possible.

Pharmaceutical consulting firms are designed to advise companies on every aspect of their business, to help them be more successful and reach maximum profitability.  A pharmaceutical consulting firm can give your pharmaceutical business a plan on how to achieve outsourcing efficiency, as well as fill you in on process innovation tips you may not be aware of.  They can also help your business with licensing, business development, brand management, as well as product distribution and process efficiency training.  They can look into your business and see what you can do to make your product better, safer and your business more efficient.  Before looking to outsource a vital part of your pharmaceutical company, discuss the plan first with a pharmaceutical consulting firm whose job it is to make sure that you will make the best decision for your company, not to mention your consumers as well.

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The healthcare and pharmaceutical market research company Manhattan Research, has established that three out of four nurses recommend health websites to the patients they tend to.  The study focused on the nurses’ preferred technologies, how they are implementing them now, and how they plan to continue utilizing them in the future.  This study was conducted online among a sample of 1001 U.S. nurses and physician assistants.

It was discovered that nurses are very knowledgeable about health technology.  Normally, and just the same as a doctor, a nurse spends around eight hours a week surfing the Internet for professional reasons.  Most of this time is in between patient consultations.  Also, nurses proved to be very active and interested in learning about medical product information online; more than eighty percent have clicked on biotech, pharma or device companies’ websites during the last year, especially Merck, AstraZeneca, Pfizer, Sanofi-Aventis and Eli Lilly.

Even though marketing departments and pharmaceutical consultancy firms are aware of the importance of nurses in patients’ health care choices, it has been hard to pinpoint an effective way of taking advantage of this situation, until now.  Manhattan Research’s study clearly presents the big opportunity the Internet is.  It is a key element to influence and connect with nurses, and thus, reach patients directly and effectively.

Among the topics analyzed in the study are:

-    Technology and Internet use for professional purposes, including email, websites visited, search engines used, wikis, social networking sites, HCP online communities, newsletters, blogs and podcasts
-    Channel mix, what sources are preferred for professional information and the use or interest in pharmaceutical website features
-    Email use and opportunity, how they communicate with patients
-    Patient interaction and education, the source of patient education materials, the recommended websites and influence on treatment decisions
-    Handheld devices, the frequency, professional functions, clinical references and preferred points of access
-    Practice technology, electronic prescribing, EMR use and activities
-    Continuing education, current and future way to do it (online, mobile, traditional), websites used
-    Practice profile, work setting, number of patients seen and number of prescriptions written

This is a study worth reading.  For more information on the results, visit www.manhattanresearch.com.

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