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March did go out like a lamb, as it was supposed to. We know for sure that spring is here, according to the geese, gophers and crows. Guaranteed that the grass is going to turn green, trees will bud out, soil will be prepared for the ‘new’ growing sea

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

son, the sun will be hotter, days get longer, bikes are out and people are shedding winter coats! So much is taken for granted as winters bleakness turns into the spring season of renewal and hope. It is no coincidence that Easter follows close behind.

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

Examples of combination products may in

While spring is a time for nature renewal and indoor clean up, Easter is supposed to be a time for renewal of heart/soul/mind. But…is it? The weeks of Lent leading up to Easter are supposed to be a time of personal reflection. Is it? Or has this too 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.

een lost in our ‘material world’?

It seems that human nature has become complacent with certain celebrations, as ‘reasons for the seasons’ have been lost along the way. We have all been raised with certain values, traditions and beliefs, which are nor

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

mally passed to generations below. How often do we take time to stop, reflect and remember those reasons? I recently allowed myself some reflective time about Easter.

I feel double blessed because I got to celebrate Easter of both calendars. Being of

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

Combination pro

Romanian decent and Greek Orthodox faith, we followed what is called the Julian calendar, so the date was different than the regular calendar. This year, for example, Easter falls on April 23, one week later than normal calendar. A lot of our celebrat

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

ions focused around traditional food, both at church and at home. Certain ones stand out in my mind like, cozonac and colaci{fruit and braided breads}, plachinta{streudel} and coliva {wheat salad}.

Coliva is a wheat salad, where the wheat is cooked u

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

ntil it is swollen, sweetened with a honey type thickening like a tapioca. The wheat is very significant to resurrection and new life as the grain of wheat must die, fall to the ground and regrow. Everyone had a coloured egg to tap to their neighbours

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

egg, while saying, ‘Hristos a inviat’(Christ is risen). In response to that was, ‘Adevarat a inviat’[indeed he is risen.] It was fun to see who would be left with an uncracked egg. This is simply one example of tradition in one culture. There is some

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

thing phenomenal about the fact that no matter what our cultural background is, who we are, where we live and what our beliefs are, be that christian or not, Easter can be celebrated anywhere in the world.

The analytic part of me wanted answers as wel

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

l; who, what, when, where and why’s of this holiday, which is a season unto itself. One answer, in particular, that surprised me was that it was of pagan origin. A completely compressed version from the Encarta Encyclopedia says: “Easter, annual festi

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

Following aspects would a

val commemorating the resurrection of Jesus Christ, and the principal feast of the Christian year.” ... “it probably comes from ?astre, the Anglo-Saxon name of a Teutonic goddess of spring and fertility, to whom was dedicated a month corresponding to A

dd to the challenges in developing combination products:

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

pril. Her festival was celebrated on the day of the vernal equinox; traditions associated with the festival survive in the Easter rabbit, a symbol of fertility, and in colored easter eggs, originally painted with bright colors to represent the sunlight

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

of spring, and used in Easter-egg rolling contests or given as gifts.”

As Christianity grew and spread, it adopted certain things from the non-Christian world. To the religious, it marks a time of miracles and faith. To the more secular world, it is

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

a time of winter’s end, summer’s solstice and bright colours of summer. Bunnies, colored eggs, baskets, lilies, candles, chocolate, hot cross buns and baked ham are ‘symbols’ of the Easter season but actually, there is no connection between them and t

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

he resurrection of Christ.

Maybe the origin of Easter and it’s symbols are really irrelevant. What does matter is what is in our hearts and souls. Sometimes our hearts are heavy as we carry burdens that weigh us down like stones. Whether they are the

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

Professional from academic institutions, pharmaceutical industries, health care indust

size of a pebble or boulder, their weight places great resistance upon our growth. New hope can easily be found if we consider the stone rolled away from Jesus’ tomb. It not only allowed Jesus to rise but the disciples to enter.Do you remember the la

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

st time you rolled over a rock and there were tiny threads of grass trying to work their way out from under to see the sun. Who are we each keeping out or what gifts are being hidden when we hang onto the weight of our stones? Have we offered to help

.

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

a neighbour roll away their stone? How many special people have we missed the chance to know while we were buried in stress? I bet we would all be pleasantly surprised at the good uncovered as we start Rolling Away Stones.

"Have a Happy Easter, Celebr

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

Companies that provide selfless information through particip

ate with cheer; Receive the Savior’s love, as His spirit draws near; Enjoy this special day, smile on your face, As hearts are rejoicing all over the place; The grave is now empty, the stones rolled away, Miracles are happening, This Happy Easter Day."

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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Renovations are always a good idea if you are trying to add some value onto your home to increase its selling price. In today's real estate market you need to be able to set your property apart from the majority or other homes that are available and new rooms are a great way to do it.

There are certain times in life when smoking a cigar is part of the celebratory package. This article discusses the best occasions to smoke a cigar.

Let's face it- remodeling a kitchen can be an expensive prospect. From appliances and paint to floors and countertops, transforming a kitchen completely can require quite a bit of money and time. For most of us, tackling the entire project at once is simply cost-prohibitive. But there are ways to visually transform your kitchen space without breaking the bank. The answer lies in creative solutions to kitchen renovation; and one such idea is that of countertop resurfacing.

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