Summary - Relationships

At the airport some airlines let you check two bags, some thr

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

ee, and either one or two carry on items. And there’s always

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

Examples of combination products may in

a weight penalty.

In relationships there aren’t as many chec

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

k-in rules, you pretty much bring your bags with you and make

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

up the rules as you go along. I define baggage as things you

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

Combination pro

have going in your life such as kids, ex-spouses, job proble

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

ms, a criminal record. The question is how much of that do y

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

ou bring with you to the new relationship, and what should yo

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

leave behind? People who dated me probably thought I was car

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

rying way to many bags, and when I met someone who went on an

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

d on about their ex and how they’ve been screwed over by the

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

Following aspects would a

world it made me want to RUN.

So rather than get a weight pe

dd to the challenges in developing combination products:

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

alty for two much baggage I think it’s a great idea to have a

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

neutral person to talk to, either a counselor or psychologis

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

t, a third party to unload all that baggage. You’re paying th

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

em; so let them unburden you and your problems. Then when you

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

Professional from academic institutions, pharmaceutical industries, health care indust

are out meeting people you’ve left all those bags at home.

N

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

aturally as you are getting to know someone your past will co

.

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

me up. But if you’ve gotten you head clear to the point of de

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

Companies that provide selfless information through particip

aling with your baggage it can only help the new relationship

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 - How Much Baggage Should You Check-In?

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