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Hi! I’m a Sunday school teacher, a sheep and a shepherd. On Sunday, 15/10/06 I was teaching and I had a proble

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

m with one of the children and I took the matter to my superior. This was the first mistake I made for the fir

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

Examples of combination products may in

t person I should have asked to help me in that situation, is the Holy Spirit (He is our Helper). I sort for h

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

lp from “a person, who also relies on the Holy Spirit for help.” Reverend Klufio (in his series of “The Holy S

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

irit, the Person,”) indicates that we don’t reverence the Holy Spirit as we should and I’m guilty of that.

“W

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

Combination pro

at did God say!” she asked. I tried to maneuver my way out of answering that question because I didn’t take th

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

matter to God. She went on to say, “The devil does not want to let go of some people, especially those who ha

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

e been dedicated to him, sangomas, etc. I then remembered, “We are not fighting against flesh and blood….” Com

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

to think of it, I was fighting a spiritual war, with a canal mentality.

She went on to say: “sometimes God w

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

ll tell you to put the child on your lap or just let it go!” In response to that, I said: “A thought came to m

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

saying let it go" “Was it God or was it you who said that?” she asked. “Honestly, I don’t know” said I. Aft

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

Following aspects would a

er having said that, God said: “My sheep know my voice…” (John 10:27)

She then took the child and put him o

dd to the challenges in developing combination products:

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

her lap and started talking to the children. I continued with the lesson until the end.

On my way to my pla

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

e, I was bugged by what God said about His sheep knowing His voice. If I couldn’t tell whether the voice that

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

aid, “let it go” was God’s or my own, am I still His sheep? Have I faded away from His stable? I really have 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

consider my ways.

Pray this prayer with me…

Thank you for coming into my life
And for the work you do

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

Professional from academic institutions, pharmaceutical industries, health care indust

in me
Refill me once more with your presence
Make me whole again

Holy Spirit, You are my helper.

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

Help me to stay where God’s grace reach me.
Show me the glory of The Lord
Help me to be obedient a

.

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

d not to grieve you.

I avail myself to you
Holy Spirit, do with me, as you will.
You know the mind

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

Companies that provide selfless information through particip

f God,
Help me to continuously do His will.

You are the source of all truth,
Guide me into all trut

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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Doctors are working to determine the benefits of exercise regiments benefits in improving cognition and reducing normal memory loss so that specific exercises can be assigned to improve memory.

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