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Just how do you study the Bible -- really get into it and understand it? Perhaps the most important key to Bible study is being inquisitive, learning to ask questions of the text. Of cou

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

rse, learning to ask the right questions is helpful. But asking any question that appears to you when you read a passage is the beginning of unlocking its meaning.

Learn to Ask Quest

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

Examples of combination products may in

ions

Here's how to proceed. First, read the passage. Then be a detective; look for clues. What's going on? What stands out to you? What don't you understand? Look for anomalies -- t

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

ings that you might not expect to find here. Consider, for example, the familiar dialog between Jesus and Nicodemus:

"Now there was a man of the Pharisees named Nicodemus, a

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

member of the Jewish ruling council. He came to Jesus at night and said, 'Rabbi, we know you are a teacher who has come from God. For no one could perform the miraculous signs you are d

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

Combination pro

oing if God were not with him.'
In reply Jesus declared, 'I tell you the truth, no one can see the kingdom of God unless he is born again.'
'How can a man be born when he is

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

ld?' Nicodemus asked. 'Surely he cannot enter a second time into his mother's womb to be born!'
Jesus answered, 'I tell you the truth, no one can enter the kingdom of God unless he

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

is born of water and the Spirit. Flesh gives birth to flesh, but the Spirit gives birth to spirit. You should not be surprised at my saying, "You must be born again." The wind blows whe

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

rever it pleases. You hear its sound, but you cannot tell where it comes from or where it is going. So it is with everyone born of the Spirit.'" (John 3:1-8, NIV) Several q

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

estions occur to me as I read this:

Where does this incident take place?
What did members of the Pharisee party typically believe? How were they viewed in society?
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
>What does it mean that Nicodemus is a member of the "Jewish ruling council" or Sanhedrin? What does this tell me about him?
Why did he come by night?
Why does Jesus respond

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

Following aspects would a

as he does to Nicodemus' introductory remarks in verse 2? Isn't Jesus a bit abrupt or rude in verse 3?

Is Nicodemus' response in verse 4 mocking or is it a sincere question?

dd to the challenges in developing combination products:

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

hat does "born of water" mean in verse 6? What does "born of the Spirit" mean?

What does "born again" mean in verse 3?

What does the wind analogy in verse 8 teach us about th

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

e Holy Spirit?

You get the idea. Your questions of this passage might be different than mine, but that's okay. There are no right or wrong questions. But questions are vital, sinc

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

e they provide direction to where you're going in your Bible study. Give yourself freedom to follow some "rabbit trails," to explore one theme and then another as you get acquainted with

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

a passage.

Who, What, Where Questions

The questions will vary depending on the passage you're studying, but here are some typical questions:

Who wrote or said

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

Professional from academic institutions, pharmaceutical industries, health care indust

this?

When was it written or said?

Where did this happen?

To whom was it written or said?

What circumstance or event prompted this inc

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

ident or teaching?

Why did the person act as he did? Or say what he said?

How can I apply or emulate or obey what I learn in this passage?

You'll be able

.

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

to think of more questions. Of course, you won't find answers to all your questions, but over time many will be answered. The key is to develop a questioning mind. Then work at probing t

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

Companies that provide selfless information through particip

he text and the Bible to answer your own questions. That's the essence of Bible study. That's the way you'll learn the Bible -- and begin to plumb the inexhaustible depths of God himself

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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If you think about it, every human being is a good sales person ... they just aren't aware they have this hidden talent.

Looking for a house is a challenging one. It's a less known fact that one of the ways you can stay on top of a house search is to consider it a game, and you just have to win.

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