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I think this can be one biggest human flaws, when things go wrong we look

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

around to blame somebody. We tend to avoid responsibility. That maybe one

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

Examples of combination products may in

f the reasons as affiliates we cannot get committed to any given project b

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

cause we fear taking responsibility for failure.

No one wants to admit th

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 after all that effort they did not succeed. It is always easy to point t

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

Combination pro

he finger at others such as the promoters you purchased the information fr

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

m. However have you ever asked yourself why you even were sold in the firs

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

place? We start with high expectations of earning vast amounts of money w

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

thout considering the work that will need to take place.

Often we are sol

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

d on what we want to hear. This is a simple and easy way to make money to

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

ive beyond our wildest dreams, that is fine but let’s get realistic. You w

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

Following aspects would a

ll need to work. The only reason somebody wants something to be easy is be

dd to the challenges in developing combination products:

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

ause they do not want to do it in the first place. When you enjoy what you

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

do challenges are enjoyable. You are not interested in pointing fingers y

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

ur objective is to understand the challenges that face you. In understandi

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

g the challenges you can help others who are faced with similar problems

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

Professional from academic institutions, pharmaceutical industries, health care indust

o success begins with understanding yourself. You are human first an affil

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

iate or business owner later. Affiliation is just the ability to promote p

.

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

oducts or services that somebody else has created. Success comes from taki

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

Companies that provide selfless information through particip

g responsibility and understanding that blaming others is weak on our part

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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