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Hi there, We are lucky enough to live in the part of the country known as East Anglia and with it's gorgeous country side, woods, rivers and sea to admire.

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

We have just got back from an early morning walk with our dog down in the woods. We would like you to share in the joys we have just enjoyed.

Try and visua

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

Examples of combination products may in

ize as we describe the pleasure we have just witnessed. Walking through the woods with the steam coming off the trunks of the trees and rising off the grass

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

as the power of the rising sun unleashes its heat on the morning dew.

Looking up into the canopy of the exploding buds bursting into their yearly task of c

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

eating their leaves of different colors, sizes and shapes, with the last of the blooms hanging on. Some of the trees like the majestic oaks are still in th

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

Combination pro

ir dormant slumber yet to awaken to the coming of spring.

Looking down to see our dog Rusty bounding over the carpet of bluebells giving off their scented

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

roma for everyone to enjoy. The air filled with the chorus of songs from different birds saying hello to the awakening world. In the distance rabbits eati

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

g the moist grass while lapping up the heat on their bodies.

As we near the end of the woods our hearts miss a couple of beats from the ear piercing cry of

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

a startled pheasant disturbed from its feeding by our faithful pet. We do not know who was more frightened for those few lost heart beats ourselves, Rusty

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

or the magnificent coloured cock pheasant. Well all the tranquility has returned as we set off on our homeward journey with the increasing suns temperature

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

Back to the flowering gardens

The wonderful yellow bloom of the acacia tree has finally dropped leaving a mess on the ground for you to clear up, but a s

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

Following aspects would a

all price to pay for the bright glow of beauty it has brought you over the last few weeks. Also the weeping willows have dropped there catkins and now funne

dd to the challenges in developing combination products:

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

ing their efforts into growth with their long dangling branches.

The Camelia has been showing off with their shades of pinks and reds to glorious effect bu

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

do not forget our plant tips of dead heading, so the plants can put their effort in giving all to the remaining heads their best. Out of the plant tips thi

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

is probably one of the most over looked and yet easiest carried out.

The flowering gardens are certainly coming into their own now with every thing going

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

n . It is certainly a job to even see all the exciting changes that are happening but what you do not discover today you will find tomorrow. That is some o

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

Professional from academic institutions, pharmaceutical industries, health care indust

the delights of your gardens

Lawn care is still one of the top topics. With the glorious weather we have been having over the past weeks the lawns are on

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

he move. You should have by now had a first cut, if not do it now. If you have let your grass grow too long make sure you do not cut it lower than two inche

.

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

for the first cut, reducing down to one inch in successive cuts. Do not cut lower than this unless it is a show garden or front lawn without much foot traf

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

Companies that provide selfless information through particip

ic. If you lawn is used or in hot conditions increase the length to at least one and half inches to help retain moisture.

Hope these tips help

Sandra & Te

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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