Suggest - Relationships

There are numerous challenges, circumstances, people and issues that can have both a positive and negative impact on the quality of a relationship. Here are some of the common o

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

nes that can place external demands on a relationship thereby causing it to lose some of its intimacy, integrity, passion and even interest.

-Children
-In-laws
-Career

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

Examples of combination products may in

-Outside interests
-Friends
-Money or the lack of it
-Stress

Having said this I want to make it clear that the issues in the previous paragraph are not part

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

of relationships. Let me explain. Intimacy and integrity are not in relationships. Relationships are neutral entities. For example, if integrity has left a relationship it is

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

not because it is no longer in the relationship it is because it has left one or both of the people in it.

Why then do the items in the above list cause people to lose some of t

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

Combination pro

ese feelings, attitudes, beliefs or behaviors?

Most of our society lives their life out-side in rather than inside-out. This means that most people have turned the responsibili

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

y for their happiness, success, inner peace and behaviors over to the outside world. Just watch someone re-act to a careless driver who has cut them off or an insensitive friend

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

who has just leveled a criticism. Most people let other people or outside circumstances determine the quality of their conversation, thinking and often even their beliefs.

When

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

something happens in your life that you don’t like, don’t want, you didn’t anticipate or troubles you - typically outside-in people have to point the finger at someone or somethi

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

g else – they seldom bring the learning back to themselves. This tends to relieve them of any responsibility for personal growth or change.

Then there are inside-out people. T

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

ese people understand that everything in their life is about them and their personal control. They take full responsibility for their reactions, responses, feelings, behaviors a

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

Following aspects would a

d actions. These people never blame, criticize, judge, invalidate or manipulate others. Their simple life philosophy is that whatever happens in their life comes to them as a t

dd to the challenges in developing combination products:

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

acher to help them grow, mature, learn and understand themselves and their world.

Back to our list.

If you are an outside-in person many of the items in this list will tend to

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

ause you angst or stress you out therefore causing you to respond in some way that may have a negative impact on your relationship. You may strike out at your partner or withdra

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

from them. You may sulk or play emotional games. There are a myriad of ways in which people learn to deal with people and circumstances they can’t control.

Imagine for a mome

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

t that you have two outside-in people in a relationship together. Chaos will rule. Emotional turmoil will be the standard by which they treat each other. Growth will not occur

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd ego’s will rule the day.

If one of the partners in a relationship is outside-in and the other inside-out, the inside-out person will always be trying to help the other – see

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

he light – often in vain. If the outside-in person is unwilling to grow emotionally eventually the inside-out person may soon tire of trying and develop some of the same tactics

.

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

of the outside-in person – withdrawal, finding other interests that permit them to avoid their partner.

The key to a successful relationship is the ability to discuss openly and

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

Companies that provide selfless information through particip

honestly without personal agendas any issue that may be having a negative impact on the relationship. If you can’t do this then you both may as well learn to enjoy your solitude

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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