Advice You - Business

Stress is our reaction to people or things going on around us. Sometimes these things are positive, i.e. a vacation, a promotion or a special event. Sometimes the

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

things are negative, i.e. a traffic ticket, someone you care about is ill, or projects at work are not meeting deadlines.

How do you manage your mood when:

• The

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

Examples of combination products may in

e is too much to do and not enough time to do it in?

• People around you seem to have time to do fun things and you don't?

• Things are happening around you that

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

ou have no control over?

• Projects at work are not meeting deadlines and you are working longer hours?

Susan Vaugham, MD, a psychiatry professor at Columbia Univ

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

ersity states in her book, Half Empty, Half Full that optimists have the ability to feel in charge of themselves. This does not mean everything will go well. It m

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

Combination pro

ans they will not be overwhelmed emotionally when things get hectic or do not go well.

When you are unhappy about how things are going, there are three strategies

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

hich will help you move forward in a positive direction:

1. Alter.

2. Avoid.

3. Accept.

To decide which is the best strategy for you to use:

• Ask yourself if

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

you have control of the situation or if you can influence someone who does have control. If your answer is yes, often you can alter the situation by problem solvin

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

, direct communication, organizing and planning or time management. If your answer is no, altering is usually not an option. There is no point in focusing on thin

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 you cannot change.

• Know what your top five values are. Ask yourself what is most important to you. The more you are living your values, the more satisfied yo

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

are with your life. Saying no or removing yourself helps you to avoid tasks that will drain you. In addition, it is necessary to know when it is appropriate to d

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

Following aspects would a

elegate tasks in a work situation.

• When you cannot alter or avoid a situation, you may have to accept it.

• To accept a situation, you may have to change your p

dd to the challenges in developing combination products:

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

rception of it by asking yourself if your expectations are realistic. If not, is there another way to look at the situation, or redefine it. You can look for an o

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

portunity to do something else. See the situation as temporary. Keep it as specific as possible. For instance, if your project is behind schedule, be specific ab

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

out why it is running late. Make appropriate adjustments. Realize it is temporary.

When you have to accept a situation, you need to build your resilience by eati

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

g healthy, exercising, practicing relaxation techniques, using positive affirmations, building your support system, having faith, and commitment.

When you feel you

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

Professional from academic institutions, pharmaceutical industries, health care indust

stress level increasing, remember you have three choices:

1. Alter.

2. Avoid.

3. Accept.

To determine your best option, you also need to ask yourself two more

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

questions:

• What do I want to do?

• What do I need to do?

Needs are a high priority. They match your values or what is most important to you. Wants are differ

.

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

nt from needs. You can want many things. Those that are most important to you will be the ones you strive for in your life.

To best manage your mood, consider y

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

Companies that provide selfless information through particip

ur needs, wants, and values before you choose to alter, avoid, or accept the stressful situation in your life. Then take positive steps to move forward confidently

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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Advice You - Do You Use These Strategies to Manage Your Mood?

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