Advice Pool - Relationships

Recovery from divorce requires us to confront the emotional reality of lost hopes and dashed dreams. We also have to confront our fe

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

ars of an unknown future. When we are immersed in this emotional process, often we can't see our options or understand the reality o

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

Examples of combination products may in

the situation as clearly as when the pressure is off. We need someone whom we trust to help us handle this life transition effectiv

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

ly.

The Value of a Good "Change Buddy"

When effective, this person can significantly reduce the pressures and

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

stress of change facing us. They can help you sort out the reality of the situation from our perceptions that are notoriously "squir

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

Combination pro

elly" during this time in our life. This person can clarify the "right-headedness" of our decisions and "right-size" the effects of

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

our emotional reactions. I call such a person a "change buddy." However, not just anybody will do.

Two Necessary Qualificat

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

ons for Your "Change Buddy"

Change Buddy's should have two critical qualifications.

(1) First, they should have N

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

PERSONAL AGENDA. Their only concern is your happiness and success - regardless of what the ultimate form or final arrangement may b

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

. In addition,

(2) they should be able to tell you the TRUTH, even when it is not what you want to hear. That means you have to tru

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

t this person enough to give them permission to be honest with you, without endangering your relationship and friendship.

Ironicall

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

Following aspects would a

y, this usually rules out spouses, family members, and bosses. Those people almost always have a preferred solution they would like

dd to the challenges in developing combination products:

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

s to accept.

An Example of the Pitfalls of Choosing a Change Buddy

A young acquaintance of mine had been marr

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

ed for four years. She realized the marriage was not going to work. They had no children and she knew divorce was the right thing to

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

do. She needed someone to assist her through her transition. She chose her mother. Bad choice.

Her mother, having been through 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

ain of two divorces, had her own personal agenda for her daughter, which was to "protect her daughter from that pain and financial l

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

Professional from academic institutions, pharmaceutical industries, health care indust

oss at all costs." She pressured her daughter non-stop to reconcile with her financially stable ex, even though that was th

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

last thing her daughter needed or wanted. After a few heart-rending weeks, the daughter "fired" her mother from the change buddy ro

.

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

e, recruited an old college friend, and made a very successful recovery from divorce.

Having someone we trust to have only

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

Companies that provide selfless information through particip

our own happiness at heart will make things much easier and saner while we march down the path of our personal recovery from divorce

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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