Summary - Relationships

When problems develop, it's natural for couples to wonder if they shoul

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

d get out of a relationship. In my experience, many people are a little

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

Examples of combination products may in

to quick to get out, when they could learn a lot by working on the rela

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

ionship and working things out.

Many people mistakenly think that if t

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

ey get out of a relationship, then their problems are solved and they c

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

Combination pro

n move on.

Geographical relationship cure

I call this a geogra

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

hical relationship cure. Just because you change who you are with, all

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

your problems will not be solved.

Usually the opposite happens.

If yo

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

don't deal with the essential issues that damaged the relationship, it

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

s quite likely those same issues will pop up in the next relationship.

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

You may choose a completely different package, but the contents will be

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

Following aspects would a

very similar.

A stinking analogy

An analogy would be not to ba

dd to the challenges in developing combination products:

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

he for a week, and then put on fresh clothes in hopes that the clothes

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

ill solve the problem.

The clothes may be brand new, but eventually th

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

ey are going to stink too.

Some important issues to consider here woul

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

be:

Have you kept your commitments, both to your partner an

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

Professional from academic institutions, pharmaceutical industries, health care indust

to the relationship?

Have you done all you said you would d

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

What kind of influence are you on your partner? Are they be

.

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

ter off as a result of being with you?

It sometimes comes down to the

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

Companies that provide selfless information through particip

nn Landers question:

"Are you better off with or without this person?

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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Summary - Relationship Advice: Should I Stay or Should I Go?

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