Advice Pool - Relationships

It is amazing how some couples meet, click immediately and come together with little difficulty while others seem to be like water and oil fro

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

m the onset. Conflicting opinions and occasional disagreements are to be expected in a relationship. Two people with different upbringings are

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

Examples of combination products may in

going to have different perceptions, values and opinions. When does conflict and disagreement go from being a healthy means of maintaining an

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

ndividuality of oneself to becoming detrimental to a relationship? How does you know when it is time to admit that the enlisting the help of a

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

n outside person, such as a therapist, is beneficial?

First, take a look at the way you or your partner express yourselves when you have a di

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

Combination pro

ference of opinion:

•Is there perpetual blaming and fingerpointing?
Blaming is a defense mechanism that many people use when the

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

feel attacked as a means to emotionally protect themselves. Actually, blaming is a way to deflect hurtful feelings.

•Do your voices get l

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

ouder as a way to get yourself heard?
As defenses rise, so does volume and intonation. The irony is that no one listens when voices

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

re raised.

•Do past problems get drudged up in your current arguments?
The past does not have to be evidence of current or futu

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

e problems. The past cannot be altered. Learning from the past is important, but in the heat of conflict, are you really trying to learn from

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

he past? Or are you trying to use the past to make a case as to who’s right or wrong?

•Do emotions run high?
Irrational emotions

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

Following aspects would a

are the result of irrational thoughts.

•Do you return to unresolved issues or once the conversation is over, there is no further discussio

dd to the challenges in developing combination products:

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

about the problem?
Tabling emotionally-charged conversations from time to time is healthy, as it gives each person an opportunity to

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

calm down and recollect their thoughts. However, if you never return to the issue then it is never resolved, which is unproductive.

If you sa

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

id “yes” to a number of these questions, now is the time to consider couples counseling. These unhealthy communication patterns can stifle the

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

growth potential within a relationship.

So how is therapy going to help?

Therapy provides an opportunity to allow a trained, neutral,

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

Professional from academic institutions, pharmaceutical industries, health care indust

outside person to observe communication patterns and recognize environmental influences. In turn, a therapist provides couples with new tools

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

to open up healthy communication patterns and increase positive interactions. Therapy also helps couples express their needs, respect differen

.

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

es and embrace similarities. So if you find that you feel unheard, have difficulty expressing yourself or feel like the only way to get your p

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

Companies that provide selfless information through particip

rtner to hear you is with strong emotions, you may want to consider therapy. Healthy communication is the first step to a healthy relationship

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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