E-Articles - Relationships

You are stuck in a dead-end relationship and you really want out. You do not want to hurt this person’s feelings, because regardless of how

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

bad things are, you care. How do you go about telling her that you would rather not be friends anymore? Should you just do a disappearing

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

Examples of combination products may in

act and hope he will get the point? Is it a good idea to just withdraw until you drift apart?

Just like breaking up with a lover, ending a

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

relationship with a friend is not an easy thing to do. In fact, it is so complicated that most people prefer to continue being involved w

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

ith somebody they cannot stand simply to avoid the messiness of telling them good-bye. I have heard of people pretending not to be home to

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

Combination pro

keep from spending time with a person they did not like. Sometimes, though, separation is not necessary. A lot of problems can be solved w

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

ith an honest conversation.

Here is what I suggest:

1. Have a sincere talk with your friend. Suddenly falling out of the picture is not a

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

good idea, because your friend might never know what he did wrong and will not be able to learn from the experience. And that would not be

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

fair.

2. During your heart to heart conversation, observe this person. Is she paying attention or is she just waiting for you to shut up

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

so she can answer back? Is he denying everything you say and twisting around your words to make you feel guilty? Or is she trying to work

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

hings out with you with an open mind? If your friend’s reaction is one of complete denial, then I guess it is clear indication that you ne

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

Following aspects would a

ed to move on.

3. After your talk, allow yourself some time and space to assimilate what happened. If there is hope, figure out what step

dd to the challenges in developing combination products:

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

s need to be taken to keep the friendship on the right track. Do not allow your friend to manipulate you into staying together because it w

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

ill only produce more resentment on your part, and a relationship founded on pity is hardly ever a good idea.

4. If you still feel that yo

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

u need to end it, be nice. Remember that what goes around comes around. After you have had the opportunity to think things through, tell yo

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

r friend that you would prefer not to spend time with him anymore. Assure him that you will always be there for him, but that for now it i

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

Professional from academic institutions, pharmaceutical industries, health care indust

s best to go your separate ways. Say this as directly as possible. Do not beat around the bush as that would only lead to confusion. And

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

by all means void accusing, offensive remarks.

But what happens if you are on the receiving end of the break-up? What if you are the frien

.

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

d that everybody is trying to ditch? Take the time to seriously and honestly evaluate your attitude. Maybe you need to work on some unattra

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

Companies that provide selfless information through particip

ctive aspect of your personality or maybe you just have the bad habit of surrounding yourself with people that do not really appreciate you

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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