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One of the keys to Bible study, seriously trying to learn what the Bible teaches, is to take notes. This is a primary difference,

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

for example, between reading the Bible and actually studying it. Taking notes isn't just so you'll remember it later. The very a

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

Examples of combination products may in

ct of writing requires you to formulate your thoughts clearly. Writing forces you to recognize fuzzy thinking for what it is and

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

ush beyond it. Write down what you're learning because it helps you understand it better.

A Three-Ring Binder Approach

I

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

recommend that you begin a notebook in which to record your observations or research. Forty years ago I began taking notes on 8-

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

Combination pro

/2" x 11" binder paper. In the left margin I would record the date. In the top right corner I would record the book, chapter, and

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

verses of the passage I was studying. This made it easy to file my notes in scripture order. I began with a single 3-ring binder

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

but now my binders fill a five-foot bookshelf. I look back at some of my early insights and am reminded of how the Holy Spirit h

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

as taught me over the years. Start small, but take notes in a way that can be expanded easily.

Journaling

Another approa

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

h is to get a bound book that you can take notes in -- a kind of journal. (I've tried that, too.) Journaling has great value, but

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

a bound notebook that contains many topics is difficult to organize or index in such a way that you can find your notes on a par

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

Following aspects would a

ticular verse in the future. That's why I really like the binder paper approach.

Taking Notes on Your Computer

You could

dd to the challenges in developing combination products:

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

also take notes on a computer, naming the files in such a way that you can find them again or search an entire folder for a word

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

or phrase. It's probably a good idea to print out your notes when you're finished and file them. Back them up, too, since compute

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

s have a way of crashing occasionally. You wouldn't your labor of years of study to be lost because your computer had a bad day..

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

I am so glad I began the habit of note-taking as part of my Bible study. Now when I study a passage again, I can go back

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

Professional from academic institutions, pharmaceutical industries, health care indust

to my notes. This way I can quickly review what I learned the last time I studied it and what I need to explore next.

For Bible

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

teachers, small group leaders, and preachers, such a notebook of previous studies becomes especially valuable. But taking notes i

.

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

n't important just because you might need them to carry out a ministry. Taking notes helps you as an individual probe the scriptu

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

Companies that provide selfless information through particip

res carefully and systematically. And in doing so, you are seeking more than spiritual understanding. You are seeking 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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