Summary - Relationships

Personal responsibility is often a difficult issue for women who have been physically and emotionally ill treated by their partner.

It goes without saying that they ar

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 never responsible for their partner’s treatment of them.

They will, very likely, have expended a lot of time and energy in vain efforts to persuade their partner of

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

Examples of combination products may in

all the things they are not to blame for. These could range from his problems at work, to their alleged indifference to or neglect of his needs, demands and wishes, to

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

the dog barking, to a lack of toilet paper within easy reach when required, and all manner of other things in between.

Responsibility has become confused with blame.

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

(Sometimes, people who are blessedly ignorant of the reality of abusive relationships will argue that what befalls the woman is her fault. It is an argument that they

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

Combination pro

se to put a distance between themselves and something they find frightening. They can then reassure themselves that nasty things don’t happen in their world.

In fact

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

, they have missed the principle. As with rape, even if a woman dresses and behaves in a provocative - or provoking – way, that does not justify any kind of assault on

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

her. Ever.

Generally, abused women end up behaving in specific ways because they have been subjected to endless attacks and accusations. And, ultimately, any woman c

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

an be open to abuse when they become vulnerable at certain difficult junctures in their life.)

Still, blame and responsibility are, essentially, quite different things

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

Responsibility has sometimes been defined as “response-ability”.

My point, when I wrote that I was starting to take responsibility for myself, was that I was saying:

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

“I am starting to own my response-ability. Instead of telling myself that my past experience conditions and limits my present and my future, I can choose to respond,

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

Following aspects would a

or react to it. I can select my future course.”

It is very easy, when you have been, repeatedly, physically and emotionally mauled to lose sight of the person you tru

dd to the challenges in developing combination products:

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

y are, together with your worth. When that happens, you become your feelings. It is as though feelings become the last refuge. What they actually are is a straightja

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

cket.

In his important book “The Sedona Method” Hale Dwoskin observes:

‘We hold on to our feelings and forget that we are holding on to them… When we feel angry of sa

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

, we don’t usually say, “I feel angry,” or, “I feel sad.” We say, “I am angry”, or, “I am sad.” Without realizing it we are misidentifying that we are the feeling. O

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

ften we believe a feeling is holding on to us. This is not true… we are always in control and just don’t know it.

‘… even your deepest feelings are just on the surfac

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

Professional from academic institutions, pharmaceutical industries, health care indust

. At the core you are empty, silent, and at peace, not in the pain and darkness that most of us would assume. In fact, even our most extreme feelings have only as muc

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

h substance as a soap bubble.’ Feelings are incredibly powerful and persuasive for as long as you are stuck inside them. The soap bubbles of feelings have iridescent

.

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

walls that blur your vision of the outside world and endlessly reflect back to you, your own isolated, trapped image.

Personal response-ability allows you to poke your

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

Companies that provide selfless information through particip

finger into the soap bubble of feelings and burst it.

Do that and you’ll be free to reclaim your place, your stature and your role in the world beyond the soap bubble

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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Summary - Are You Holding Onto Your Feelings?

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