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The only thing constant in life is change. Change can be an exciting part of one’s life or it can be a daunting experience. However, changes can be manageable if you are prepared to handle them. Since chang

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

e is so much a part of our lives, don’t you think it is a good idea to learn how to manage it without stress?

In life, you can easily recognize change. You either embrace it, or reject it. Acknowledging an

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

accepting change already gets you a long way in accepting change. However, if you are still having difficulties in handling it, here are some suggestions that you can do:

1. Evaluate yourself and try t

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

understand your reactions to change. Are you the type of person who resists change or are you the type who dives in and becomes excited when it comes? If you can understand how you react to change, you

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

can interact with others better during the difficult times.

2. Transition is a part of the process of how you deal with change. It has three stages: a) endings –the grieving stage of the good old da

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

s; b) the neutral zone –a stage of ambiguity and not sure of the new way; and, c) new beginnings – a stage when the coast is clear, and you are ready to accept the new things on the way. If you can identify

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

which stage you are in, then you can understand better on what you need to do. It is important to be aware of this because other people might be experiencing also the same change as you have. It is always b

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

tter to know you are not alone in adjusting to new things. It makes the transition better.

3. Be careful in responding to change and transition. People’s ways are habit-forming and they often develo

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

routines. Disruptions can be nerve-wracking and can stir up emotions – mostly of the negative kind. Ask yourself questions in handling change like: a) purpose – reason for the change and why the changes?;

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

) picture – result of the change, the destination; c) plan – how to get to the next stage?; and, d) part – the role that you are about to play and where do you position yourself?

4. Help others. Sin

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

e you know how to handle change in your life, it is time for you to help others who are the same situation and are struggling with the changes in their own lives.

Furthermore, to help you sharpen your abil

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ity to handle change and to provide you with some self-help therapies, here are some ways to soothe and calm your nerves:

• Do some physical activities like sports and exercise. This will help release pres

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ure from your body.

• Share feelings and thoughts that cause you stress. If you think your problem is something serious, you may want to ask for professional help from a counselor or psychologist. Be aware

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

of when to ask help.

• Set boundaries. If you think you cannot handle the situation, do not fight it and learn to accept it until the time that you already have the capacity to change it.

• Always remembe

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

to take care of yourself. Never neglect what your body needs and learn to read your body’s signals. Eat well and get enough rest.

• Have fun. Do not overwork yourself and schedule some time for recreation

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

Stop and take time to smell the roses.

• Be a participant. Do some volunteer work in your community to help you divert your attention to something worthwhile. You can also meet new friends along the way.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

• Try accomplishing your list of tasks. The tendency for stressed people is to forget about important tasks. List them all down so you do not forget what needs to be done.

• Do not play the Mr. or Ms. Rig

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

t all the time. Give and take is the best setup you can find at this time.

• If you want to cry; cry. Crying is a healthy way of releasing pressure and stress.

• Relax. If you feel tired of your environme

.

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

t, make that escape by reading a book or creating music to bring a sense of peace and tranquility.

• Never attempt to do self-medication. This can cause more harm than good for you.

Changes in life may le

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ve you burned out but with a little help from yourself can make a whole lot of difference. Indulge yourself once in a while to distress yourself. Accept change and adapt. That is how people live and survive

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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