E-Articles - Health and Fitness

In this article we're going to take a look at one of the slightly unexpected ways that you can be diagnosed with High Blood Pressure, what it can do t

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

o you if you ignore it and one of the things that you can do about it?

Well why don’t we kick off with the cheerful bit first? Basically if left untr

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

Examples of combination products may in

ated and ignored it will kill you? How about that for starters?

“OK Steve”, I hear you cry, “hit me with the cheerful stuff and don’t hold anything 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.

ck!”

High blood Pressure is difficult to spot in the traditional sense of things and the warning signs are very difficult if nigh on impossible for 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

e lay person to identify.

You can be diagnosed in number of ways and you would be surprised how and when you can pick up a diagnosis of High Blood Pr

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

Combination pro

essure.

This is not meant to act as an attempt to instil wholesale panic amongst folks. Take yesterday afternoon for example.

I had a routine examin

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

tion at my opticians for a repeat prescription and to check out my eyes for reading glasses. It was the usual drill for someone in their forties. Basi

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

ally as a friend of mine had cheerfully pointed out a few years back it wasn’t a case of my eyes being faulty it was more of a case of my arms not bei

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

g long enough when I wanted to be able to read a book comfortably!

So, back to the Opticians. There I was resting my chin on the support for this new

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

fangled piece of technology that they now use to check out your eyes and going through the initial process when the Optician turned to me and said “O

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

now I am going to shoot a few jets of some gasses into your eyes”.

“OK” I thought, “here goes, this should be interesting.”

Anyway a few puffs of g

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

Following aspects would a

s later – a very painless experience I must add and the Optician turned to me and said “Did you know you have slightly raised Blood Pressure? How long

dd to the challenges in developing combination products:

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

have you been suffering from it and when was the last time you saw your Doctor?”

“Ah, should have told you about that before” I said, “Yes I do suffe

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

r from High Blood Pressure and this is the medication I am on.” I proceeded to go through my prescription and she, very professionally, took down copi

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

us notes. “Does this sort of thing happen often?”

“You would be surprised by how often it does” came the reply. “When we do our first check on a new

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

atient (or one that hasn’t been to us for some time), the first thing we do is check the blood pressure in the eyes. Left untreated it can eventually

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

Professional from academic institutions, pharmaceutical industries, health care indust

ead to blindness. Quite often people don’t realise that a visit to their optician can be the first line in the defence against High Blood Pressure as

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

a condition”

“Now I see” I thought (pardon the pun) – two reasons to go and have your eyes checked regularly. Even if you think you have 20/20 vision

.

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

(and especially if you work with Computer screens and Monitors on a daily basis). An eye examination can pick up treatable conditions and deal with th

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

Companies that provide selfless information through particip

m as well as providing an opportunity to spot subtle changes that can be the forerunners of much more dangerous conditions such as High Blood Pressure

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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Cindy Ventrice is a management consultant and workshop leader with over 20 years of experience in a wide range of industries. In this interview she provides guidance for owners and leaders to assess the quality of their current recognition programs.

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