Advice Pool - Relationships

Marriages are breaking at a higher speed in modern days than anybody could predict.

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

People are suddenly shying away from marriage fearing that divorce will be around th

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

Examples of combination products may in

corner soon. There are many reasons for this. One of them is to think that our 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.

ner knows all about how we think and the kind of problems we are facing. That does n

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

t happen at all. This assumption kills many marriages. What to do? Let me tell you.

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

Combination pro

To begin with stop assuming that your partner knows all about you. You may be very d

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

isturbed about something and getting angry with your partner for not supporting you.

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

But does your partner know that you are very disturbed? Does your partner know the

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

eason of the disturbance and what kind of support you need? Most often that is not t

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

he case.

It is common experience that once the marriage breaks down, both the partn

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

rs blame each other citing many instances. The other partner protests that he/she kn

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

Following aspects would a

w nothing about them, or never took them seriously. That is the result of communicat

dd to the challenges in developing combination products:

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

ion gap in this area. As spouse, it is your duty to find out what is going on in the

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

mind of your partner. If your partner shies away telling you, you need to talk and f

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

nd out. Otherwise you will find the situation spiraling out of hand over time. If he

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

/she does not tell me, why should I ask? This does not work. Keep yourself fully inf

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

Professional from academic institutions, pharmaceutical industries, health care indust

rmed about all the issues that matter to your partner and give support. That is the

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

ey to bonding and happiness.

Please talk to your partner about all the issues that

.

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

matter to you. Talk to your partner about your feelings and your expectations. That

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

Companies that provide selfless information through particip

ill help cement a better relationship. Because now your partner knows what is needed

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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