Useful Articles - Relationships

So, you’ve decided that you’re no longer “a couple”, but for whatever reason, you and your spouse have decided to stay together "for the sake of the children".

Isn't that what the children need? Don’t they need the

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

strength of a two parent household in this mad society that we live in? Don’t they need the emotional assurance that Mom AND Dad are together? Don’t they? Or do they?

When my ex and I decided to divorce, we decide

; 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 that he should probably live in the house with the children and I, for their sakes. We weren’t getting along to make things worse, as he was still doing the ‘single dude’ thing outside of the house, skulking in at

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

all hours of the morning, making hushed calls from his cellular phone, etc.

I thought that I was doing the best thing for the children at the time. I allowed him to stay, because I didn’t want to put them through

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

the emotional upheaval that I was sure that they would have to endure if I kicked him out.

Something happened one night that changed my opinion on that whole “staying together for the kids” thing.

We were having o

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

Combination pro

ne of our usual “discussions” at about two in the morning. As usual, it got loud, and our eldest daughter woke up (she was ten at the time), came out of her room, and said, “Will you two stop it?! I can’t stand it a

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

nymore!” It was like a light bulb lit up in my head, and I thought to myself, “Why are we doing this? Why are we putting these children through this nonsense? They’re clearly not in the best emotional place that the

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

y could be. We’re done.” At which time, I went downstairs, and sat at the kitchen table. I thought long and hard about what I was doing. Why was I really allowing him to stay? Was it really for the kids? Or was it f

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

or me? Was it because of my fear of being ‘alone’ that I allowed my children to hear and be witnesses to things that I would prefer they not? Was it because of my fear of what kicking him out would bring on?

Whatev

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

er the reason, I had to stop thinking about whatever it was that I was afraid of, and start thinking about just what his presence in the house was doing to the emotional well-being of our children. They were miserab

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

le. He had to go, and that was that.

It’s my job as their mother, to make absolutely certain that my children are protected, emotionally, physically and spiritually while they’re under my roof. So, I stood up from

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

Following aspects would a

that kitchen table, and walked back up those stairs. He was standing at the top of the staircase, looking straight down at me. I looked up at him and I said, “You have to go.” To which he replied, “Go? Go where? Whe

dd to the challenges in developing combination products:

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

re do you expect me to go at three in the morning?” I headed back down the stairs as I said, “I don’t care where you go, but you need to be out of this house tonight.” He gave me the usual caveman response, “Well, i

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

f you want to try to make me go, go ahead.” But I was prepared. I said to him, “We can do this one of two ways. You choose. We can do this the easy way, where you get your things, and walk out the front door on your

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

own steam, or we can do this the hard way, where you give me flack, and I call someone who’ll help you be out of here in the next 15 minutes, with or without your stuff. It’s your call.”

So, after about two minute

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

s, he packed what he could into a duffel bag, kissed the kids, and walked out of the front door. Our eldest daughter, closed the door behind him, and said to me as she did so, “Thank God. Now we can have some peace.

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

Professional from academic institutions, pharmaceutical industries, health care indust

“ Those words coming from her mouth changed my thinking forever.

When you think that you’re staying together “for the kids”, think again. Whatever emotional upheaval you’re going through in your situation, they’re

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

feeling as well. Don’t think for a second that your children don’t see it. They see and hear much more than we realize. I decided that I would much rather have my children in a loving, one parent household, than a d

.

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

ysfunctional, two parent household, in which the parents are constantly at odds with each other. Kids are all eyes, and ears. They take in a huge percentage of what they see and hear at home. My household is happy a

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

Companies that provide selfless information through particip

nd healthy now. There’s no fighting. There’s no stress.

I made the right decision, and my children are much happier for it.

Martinis for Everyone!

Debbie Burgin

Copyright 2005 Debbie Burgin All Rights Reserved

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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Article looks at the origins of EAP programs, and what they do for employers and employees. An argument is presented that states that due to complexities at home and at work, they are needed to improve productivity and workplace performance.

XML is a vital part of the Web infrastructure, powering a wide range of things from RSS feeds to Gmail to OpenOffice. What precisely is it? From where did it come from?

For this, if you are getting a divorce, you need a divorce lawyer to properly present your case to the family court. You need to show the court that you have done nothing in your relationship that caused both of you to divorce and also, when getting the child’s custody, you need to be able to show the judge that you can support your child in education, shelter and also the needed parental care.

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