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Enjoying breakfast with my young son one morning at a local restaurant, I couldn’t help but wonder what he was thinking. I smiled as I watched him observe his surroundings, scanni

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

ng the table and taking in all the sights. It’s such a refreshing experience to imagine yourself seeing this world again for the first time.

Before pouring myself some water from

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

Examples of combination products may in

pitcher, I removed the lemon slice from inside and placed it on a small plate in the middle of the table. As I started to pour the water, my son grabbed the lemon slice and quick

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

y put it in his mouth, taking a big bite.

The poignant look of pain on his face from the bitter taste of the lemon made me grimace. My mouth started watering aggressively as my e

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

es and nose scrunched into a tight knot. He immediately dropped the lemon and we both sat there with the exact same look on our face, wondering what just happened. We went from q

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

Combination pro

uietly sitting at the table waiting for our breakfast to arrive, to grimacing at the bitter taste of a lemon.

As I sat there still tasting a lemon, which had never touched my mout

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

, I finally understood everything I had been studying for the past ten years. I understood that our mind takes our thoughts literally. As my son bit into the lemon, I underwent th

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

exact same physical reaction he did. My mouth watered, my face grimaced, and I could vividly taste the flavor of the bitter fruit in my mouth.

Before then, I had known the benef

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

ts of positive thinking, but I had never taken those teachings literally. At that very moment, I understood that our thoughts literally become things.

Whatever thoughts we feed ou

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

r mind – whether it be of fear, wealth, peace or lemons – our mind will manifest. The results we see are in direct result to the mind’s response to the thoughts we feed it. Sure,

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

I knew I wasn’t biting into that lemon, but it didn’t matter. My mind developed the experience for the thought I gave it. My experience was as real as if I had put that lemon str

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

Following aspects would a

ight into my mouth.

Until that moment in the restaurant, my goals were sunshine and bubbles on the surface, but beneath them there was a strong undercurrent of apprehension. I co

dd to the challenges in developing combination products:

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

stantly worried about how I would accomplish something, instead of simply keeping my eye on the goal. Instead of grabbing hold of the situation I wanted with both hands and swallow

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

ing it whole, I kept a reserved nature about my goals buried beneath the surface.

The problem is, action follows thinking. You cannot achieve goals by acting alone. In fact, ther

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

is no amount of action that can sufficiently triumph over the thoughts you secretly harbor in the dark recesses of your mind. If your thoughts are apprehensive and mild, then you

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

actions and results will be equally apprehensive and mild.

Whatever your goal is – whether it be your own business, a brand new office, or more customers – think about the hidden

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

Professional from academic institutions, pharmaceutical industries, health care indust

thoughts that are hindering its realization. Is it fear? Is it worry? Is it doubt? Peel back the layers that hide these thoughts and shine a light on them. These thoughts, not jus

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

t the ones on the surface, are creating the world in which you live.

Goals can only be achieved by first taking control of your thoughts. All of them. Positive thoughts backed

.

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

ith worry and fear will not bring the positive results you desire. The only way of creating the world you desire is by filling your mind with right thoughts and simply leaving no

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

Companies that provide selfless information through particip

oom for wrong ones. Celebrate your goals and grab them fully, without any negative thoughts to weigh them down. When you stop thinking about the bitter, you’ll only taste the sweet

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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