Advice Pool - Relationships

No relationship is equal give and take. In every relationship, both the partners make

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

adjustments to make the relationship a success. Both give up many choices in life and

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

Examples of combination products may in

try to contribute for the continuation of the relationship. Sacrifices are always call

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

d for in a healthy relationship. The relationship thrives on them. When we sacrifice w

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

e feel good because we feel worthy. Having given up something always makes us feel goo

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

Combination pro

d. It can also make us feel bad, if it goes on from one side and the other partner n

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

t even acknowledges that. The resentment sets in to the detriment of the relationship.

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

Why Sacrifice- two people cannot relate and live together peacefully, if they set th

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

eir own conditions of living. They have to draw a common way and sacrifice their own h

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

bbies, interests, and many other interests. Many adjustments have to be made to make a

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

relationship succeed.

Are You Sacrificing More - human beings are all different. Som

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

Following aspects would a

e of us are givers by our natural instinct. In any relationship, such people will alwa

dd to the challenges in developing combination products:

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

s give without any second thought. As the relationship progresses, such givers keep on

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

sacrificing more and more to make the relationship work and keep the partner happy. S

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

lowly the resentment may develop. I am only giving since years. I am not getting anyth

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

ng in return. Why am I being demanded to give again and again. I have my own life and

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

Professional from academic institutions, pharmaceutical industries, health care indust

desires. What about that? Why the world is becoming selfish? No body bothers about my

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

comfort. Am I a sacrificial goat? Such thoughts slowly develop and destroy the relatio

.

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

ship over period of time. Any relationship that began with imbalances would not surviv

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

Companies that provide selfless information through particip

e long if checks are not kept. If you sacrifice more, please stop and review your life

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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