Summary - Self Improvement

Poised to Drink

Before the rains came my flowers were far and few in between. While strolling

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

through my garden with camera in hand, I noticed one flowering plant had a few blooms among many spent ones. Disappoint

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

Examples of combination products may in

d and not expecting to see much excitement, I was surprised to notice a beautiful butterfly poised to drink from a lone

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

wisp of delicate purple.

Captivated, I focused my camera to the best of my ability, which is limited to say the least.

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

icture taken, I stayed put until the lovely creature departed.

Excited like a child, I ran upstairs to download my trea

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

Combination pro

sures only to find most were blurry. Only a couple held any promise. One captured my heart with one of those quiet littl

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

"God Whispers" I have so come to love, full of truth, yet, seasoned with mercy and grace.

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

And He whispered...

"When rain is scarce, you will bloom. When times are hard

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

ou will grow. When all is not well for others, you are their resting place. When you are found in need, you will give."

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

"I want you to know the depth of beauty dwelling in you; therefore, I am sending many people, like intricately designed

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

butterflies, to drink from you, to drink from My fountain within you. They in turn will spread pollen to many other plac

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

Following aspects would a

es. The essence I have placed in you, the portion of who I am in you, will then be transported far and wide, allowing My

dd to the challenges in developing combination products:

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

Kingdom to grow."

"You like a lone flower rooted in one place, growing despite all odds have the necessary nutrients to

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

feed many."

"Beauty dwells everywhere if you are willing to see. It dwells in you and I want you to see the majesty of

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

it all. If one lone lilac colored flower can attract a beautiful butterfly to come and drink from its depths, how much m

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

ore will you be able to do?"

"Never think you are alone or what you do doesn't matter. Someday you will know how much p

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

Professional from academic institutions, pharmaceutical industries, health care indust

llen was spread from your open petals."

I love you,

Father

Father,

I humb

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

le my heart and receive all You have said about me. I am overwhelmed at Your goodness and mercy. I now see trials in my

.

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

ife in a different light. All things are possible with You.

I spread the petals of my life upward to receive sweet nect

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

Companies that provide selfless information through particip

ar from you, and I open the flower of my life outward to share all You have given. May Your name be glorified in me. Ame

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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