E-Articles - Relationships

People whom we choose to be close to are called our ‘family of choice,’ and these people have a strong impact on our lives. A ‘significant other’ knows us almo

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

st as well as we know ourself. Our respective ups and downs, joys and stresses profoundly affect both people. Sometime they will be the carrier of our stress

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

Examples of combination products may in

and sometimes we will be the carrier of their stress.

Over time, extended family and friends move in and out of our lives leaving permanent imprints—both posit

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

ive and negative—on each of us. Maintaining healthy relationships becomes a balancing act and takes considerable time.

A healthy relationship is complex and s

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

gnificantly personal and it is a challenge to view it objectively. All healthy relationships involve other people, but each person has their own point of view

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

Combination pro

and ways of reacting to feelings or the travail, called life. Each person needs to accept that creating a healthy relationship is a 100% responsibility for eac

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

h person. The blame game--"If it weren't for him/her...."--never solved anything.

Heavy emotional issues in a relationship are stress producing because it caus

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

s one to feel threatened. One might need to make a change; one might feel out of control, and sometimes one’s expectations cannot be met the way one wants.

Th

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

e key to healthy relationships is simple, but for most, difficult to the degree it is avoided—I speak of the act of discussing stressors with the other person a

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

nd forgiving their transgression. These unaddressed issues are life stressors and happiness robbers. For instance, the time and energy it takes to nurse old gru

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

ges without forgiveness is formidable, because it creates tension and impacts everything in one’s life with a heavy cloud. People in healthy relationships read

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

Following aspects would a

ily bring issues of discomfort with each other into the open. Remember, people make mistakes. “To err is human—to forgive is divine.” Alexander Pope

Relati

dd to the challenges in developing combination products:

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

onships can be stress producing as well as rewarding. Feelings can be a curse or a blessing. Only robots are left unaffected by emotions within the relationshi

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

p dance. All relationships, no matter how healthy, require skill and management. Each person needs to commit to creating a healthy relationship for oneself and

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

the other. Win/win negotiation is a valuable skill in creating a healthy relationship. See: Everyth

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

ing-is-Negotiable-Including-Sex-Learn-to-Do-it-Well

It is important to pay attention to our own interactions to keep a healthy balance. Relationship inter

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

Professional from academic institutions, pharmaceutical industries, health care indust

-independency, boundary issues, limits and goal-setting are skills, we can master and use to eliminate unnecessary stress, rather than remaining victims of rela

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

ionship stress.

Forgiving is for you, not for anyone else—paradoxically the outcome shifts the relationship to a healthier level. The fastest way to create ch

.

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

ange in our lives is to shift what we are doing—the other person is then obligated to shift as well—because we have changed--the other person can't stop you fro

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

Companies that provide selfless information through particip

m changing what you do or how you react. In that sense you are empowered to shift the relationship to a healthy level--provided that it is mutually beneficial

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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