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"Come with me by yourselves to a quiet place and get some rest" (Mark 6:31c).

Our t

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

ender Jesus bids us, "Come -- with ME." How grateful we are that Jesus meets us at o

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

Examples of combination products may in

ur place of weariness. He says come, not go. He says to come to a peaceful place. In

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

the rustle and bustle of our world we need Jesus' corner of composure and confidenc

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

. He says, come by yourselves. Jesus knows that only when we are alone will we be qu

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

Combination pro

iet so that we may hear what He has to say to us.

There are many places and ways, r

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

easons for and seasons of rest. Especially in nature do we find a holy intermission.

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

There is nothing like a sunrise, a sunset, an hour on the river, or a walk at night

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

when the stars sparkle, to give repose to our weary souls. Our humane Jesus doesn't

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

want a left-over from labors, so He asks us to set aside our physical and mental str

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

esses so we may re-create -- restore -- stamina and stimulus.

“My soul finds rest i

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

Following aspects would a

n God alone” (Psalm 62:1a). When it is calm we use the oars. It is when the storm co

dd to the challenges in developing combination products:

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

es up that we cast our anchor. When life is sailing along smoothly, we make our reso

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

lutions and use our determination but, when the squall bears down, then we take hold

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

of "hope as an anchor for the soul, firm and secure" (Hebrews 6:19). We cast our an

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

xieties into the calm depths of confidence.

"I will lie down and sleep in peace, fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

you alone, O Lord, make me dwell in safety" (Psalm 4:8). The only guard we need is

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

God. In our world of turmoil we must know there is Someone outside ourselves who we

.

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

can absolutely trust. It is God only; all other help is vain.

"Thou hast made us fo

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

Companies that provide selfless information through particip

r Thyself, and the heart never resteth till it findeth rest in Thee" (St. Augustine)

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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