Suggest - Relationships

"Quarrels would not last long if the fault was only on one side." ~ Fran?ois de la Rouchefoucauld.

"Be not the first one to quarrel,

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

nor the last to make up" ~ Anon

It is about time we stopped blaming out our spouses for everything that goes wrong in our lives. Wh

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

Examples of combination products may in

t a tendency we have to assign guilt to other people! Everyone makes mistakes, including us, or should I say, especially us.

Our pro

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

lem is that we expect a lot from other people, especially our children and our spouses and, more often than not, they will not corres

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

ond, not because they are unwilling, but because they are humans. And then, bang! Off we go, criticizing, assigning blame, and even w

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

Combination pro

orse, yelling. Now I ask: how fun is it to live with someone who is constantly blaming others for everything that happens? Can’t we j

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

st let go and accept that no one is perfect?

In my case, except when Alex was learning to drive, when I screamed and yelled a lot, I

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

am not the yelling type. Nevertheless, I see myself blaming him for everything that happens in the house. And consider he is only my

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

on. What was I used to doing when I had a partner? Luckily, he is now old enough to stop me. Last night, for example, I was at my com

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

puter and he came to speak with me. Now, being a kinesthetic person, he touches and fiddles with everything. I usually have a lit can

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

le by my desk when I am working. I don’t know how he did it, but during our brief conversation, he managed to extinguish the candle w

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

Following aspects would a

th the wick inside the wax. I looked at the candle, gave him the evil eye and was about to complain when he said: "Oh, well!" There.

dd to the challenges in developing combination products:

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

hat was enough to shut me up. Clever boy!

Now, if only I could shut up all the time! I am learning, though. And the many times I acc

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

use him of wrongdoing, I immediately retract. I am doing my best, being confident that even before he moves out, I will have mastered

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

accepting the man he is.

So, how can we prevent blame and accusations in our relationship? It takes effort, but by paying attention,

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

we can become aware of this nasty behavior and put a halt on it. Arguments will vanish instantly the day we decide to lower our expec

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

Professional from academic institutions, pharmaceutical industries, health care indust

ations and accept the fact that it takes two to tango. Let’s understand that we are also to blame; always.

A Word of Advice Ladies:

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

Before we criticize, or God forbid, attack, let’s become aware of the need to do so. So many problems are easily solved without reso

.

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

ting to yelling.

Gents: Do not allow a conversation to escalate to an argument. Nicely and gently, explain that there is no need to

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

Companies that provide selfless information through particip

ut a fight or for yelling and that you will now remove yourself from the storm but would be right back when the "flood is controlled.

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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