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It is so obvious that God works and thinks on a totally different level than we do. I have spent most of

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

my life in my left logical side of my brain trying to figure out God, people, events and reason. Only to

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

Examples of combination products may in

be left frustrated, irritated and emotionally dehydrated.

What makes it most interesting is, we look bac

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

and the flow of our lives makes perfect sense and in God's perfect timing. The question is, "Is it possi

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

ble to live in a state of mind where we just go with God's flow, without trying to grab hold and figure l

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

Combination pro

fe out our way? The bible says it is. "The ways of God are without fault. The Lord's words are pure. He

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

is a shield to those who trust him." Psalm 18:30.

I love inner tubing down a river. You have no control

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

of what direction you face, the current sets your pace and you are directed by nature's obstacles through

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

the water. While you have absolutely no say in your destiny down the river there is such a comfort sitti

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

g on that tube floating on top of the waves feeling that powerful body of water underneath you.

A questi

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

on I ask myself is, "Why do I even think I need to understand God's ways?" Do we think our ways are bette

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

Following aspects would a

r? Sure we do at times. Do we need to think about how we are going to get down that river the most effect

dd to the challenges in developing combination products:

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

ve way on that tube? Absolutely not. We just know in our hearts if we stay on that tube(word of God) we w

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

ill have a fun and interesting ride down the river and eventually get taken to where we want to go.

When

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

we finally get to the point where we fully comprehend and ACCEPT the fact that God's ways are not our way

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

s, and our plans are not better than God's, we tend to enjoy the river of life more and look forward to t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e journey ahead without uncertainty.

There's a chance God is working in your life above water or in the

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

currents below right this very second. Do you need to fully understand what he is doing? Probably not! Gr

.

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

b that inner tube, get on top along side God(study the word) hold on in trust and let the river of his Ho

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

Companies that provide selfless information through particip

ly Spirit give you a ride of a lifetime this week. And what's even more fun is taking someone with you!!

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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