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E-Folder - You Can Reach Any Goal In 7 Easy Steps
There is a difference between people that reach their
goals on a regular basis and those that do not. That
difference is always some variatio According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product n of the following
seven steps to success. Whether you are a student struggling to succeed in school, or a mega-millionaire figuring ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in out your next big project, the process is the
same. Become clear about what you want... Be specific about what your goal lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. is. It is not enough
to say I want to be rich. Instead an attainable goal
would say “I want $100,000”. Don’t say I want a
better house. here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe Say “I want a 4 bedroom brick ranch
on a quarter acre in Tucson”. The clearer you can
be about what you want, the easier it is for you to
g d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro t there. Make it real... Write down your goal and put it on the bathroom mirror. A goal not written down is nothing more t ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc han
a wish. The act of committing it to writing makes it
real. Keeping it in front of you every day acts like a
nagging friend to hold you easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi accountable for achieving
it. Paint a target... Determine when you want your goal to happen. Then include the date in y nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically our goal. None of us ever
do things without a deadline. Think back to when
you were in school. Would you have done your
homework if it wa and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ s not going to be collected the next
day? Setting target dates motivates us all to do the
things necessary to make our goals come true.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi br> What will it take... This is where lists are your friend. Make a list of everything you can think of that you will have to do ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a
to reach your goal. Revisit the list regularly and add
to it as you think of new things. Keep adding to the
list until you reach your goal dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod . Put some structure into your plan... Not every item on the list is as important as the others. Organize your list into cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin the things that are
most important and those that are less important.
Then arrange them in some order that makes sense
to you. Do the firs tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen t things first. For example, you
can not paint the house until you buy the paint.
Start Now... Don’t wait for the right t? As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel time. Taking action is the
most important step in reaching your goals. As you
move toward your goal it will get easier to keep
going. Like ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust rolling a stone across a field, the most
energy is expended in getting it started. Take some
action. Just get moving now. Be Con y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products sistent... Get in the habit of doing something every day. As you mark the items off your list, your momentum will grow. There is so . As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de mething very magical about moving
closer to a goal. So do something every single day
that moves you closer to your goals. If you be elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip gin to take these steps on a regular basis
you will be amazed at how much you accomplish and
how easy it really is to reach any goal.
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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