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The Bible tells us that we need to be led by the Holy Spirit (Romans 8:12-14, Galatians 5:16-25). Therefore, it is neces

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

sary for us to discern the prompting and guidance of the Holy Spirit if we are to live successful lives.

Getting to kno

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

Examples of combination products may in

God better is ultimately the key to hearing from, and being led by Him.

1. Spend time alone with Him in prayer and Bib

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

e reading. This should be a priority, not a chore that you grudgingly do if you happen to have some spare time.

2. Duri

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

g your time alone with God, don't expect to feel something. We are to live by faith (2 Corinthians 5:7), not by feelings

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

Combination pro

3. Make sure that the Bible version you are using is easy for you to read, otherwise you will become discouraged very

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

uickly. Your local Christian bookstore can show you several versions of the Bible and discuss their strengths and weakne

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

ses.

4. Expect Him to speak to you. Sometimes you will get an immediate response, but most of the time you will need to

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

wait for awhile and keep watching for the answer in whatever manner God chooses to speak to you.

5. Listen to your cons

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

ience and be quick to obey if you should lose your peace about something. If you ignore your conscience, you run the ris

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

of your conscience becoming "corrupted" (Titus 1:15) and "seared as with a hot iron" (1 Timothy 4:2), and it will be mo

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

Following aspects would a

e difficult to hear from God.

The apostle Paul wrote about our consciences frequently. He said that he kept a clear con

dd to the challenges in developing combination products:

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

cience before God (Acts 23:1, 24:16, 1 Corinthians 4:4, 2 Timothy 1:3,) and he said that we should do the same (Romans 1

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

:5, 1 Timothy 1:5, 19, 3:9) so that we don't shipwreck our faith. We can know that we are hearing from God by listening

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

o our conscience.

~ "I speak the truth in Christ--I am not lying, my conscience confirms it in the Holy Spirit" (Romans

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

9:1).

~ "Our conscience testifies that we have conducted ourselves in the world, and especially in our relations with y

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

Professional from academic institutions, pharmaceutical industries, health care indust

u, in the holiness and sincerity that are from God" (2 Corinthians 1:12).

~ Our consciences "bear witness" to the truth

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

(Romans 2:15), because the truth is "plain to our conscience" (2 Corinthians 5:11), and the "the Holy Spirit testifies w

.

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

th our spirit" (Romans 8:16) to confirm the truth.

If we learn to obey our conscience and let peace be our umpire, we w

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

Companies that provide selfless information through particip

ll be able to let God lead our daily lives and assure ourselves of success and prosperity.

Copyright 2005 Daniel N Brow

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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