References - Home and Family

The prime directive of parenting says that all young have a right to expect that those who bore them will raise them to maturity. For many animals, it’s no big deal. Mom lays eggs, Dad fertilizes and the job is done.

But for we humans, it’s a different

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

kettle of fish. Our kids take about twenty years to reach maturity and they need us all along the way!

Is Sacrifice and Dirty Word?

One parenting debate I’ve increasingly been hearing is who comes first? Should parents sacrifice for their kid

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

Examples of combination products may in

s or should parents care for themselves first? If we give up everything for our kids do we run the risk of raising selfish little brats who expect the world to bow down whenever they want something? If we look after ourselves first and meet all our nee

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

s do we run the risk of becoming selfish adult brats who don’t figure we should have to waste our time on the mundane and petty details of childraising?

Is there no middle ground?

Sacrifice is part of parenting. It starts the minute a woman dis

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

covers she’s pregnant. She changes her lifestyle. Suddenly the young woman who loves to have a beer after her soccer game opts for club soda. She is looking after her child first and delaying her wish for a beer, for nine months. While she wishes she

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

Combination pro

could have a drink, she doesn’t feel badly, she isn’t suffering. She is, in fact, thrilled to be able to make this sacrifice to nurture the growth of a healthy fetus.

Okay, there are those of you who are saying, “But that’s different. There’s no real c

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

hoice if you want a healthy baby.” All the things we do for our children - hanging out at the park when we’d rather be at home, going to parent meetings at the school instead of catching up on the laundry, using a precious holiday day to drive kids on a

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

field trip’ all contribute to raising a healthy child who will become a mature, capable adult.

Kids First

One of the supreme ironies of parenting is that if you look after your kids first, you can look after yourself more easily. When you take

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

a flight on an airline you are told that if the oxygen mask falls you are to put it on yourself first, then look after the others who may need your help. And that makes sense. It also takes only a few seconds.

In other arenas of our lives as parents, t

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

king care of ourselves first means that our kids miss out. Going to the park with my kids when they were little was never my favourite experience. For my kids, going to the park was not only a joy, but important to their growth and development. They n

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

eeded the exercise, the socializing, the chance to challenge their bodies and see just how far they could climb, how high they could jump. Staying home because that would meet my immediate need might have been an option, but not a responsible one. I we

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

Following aspects would a

nt because it mattered to them. They would never be toddlers or preschoolers again so a trip to the park was the right thing to do then .

But, as it turned out, it did meet my needs. First, I did enjoy watching them have so much fun. I got exercise w

dd to the challenges in developing combination products:

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

lking to and from the park, and some probably much-needed fresh air. And, more importantly, when we got home my kids were a pleasure. They were able to settle down to reasonable play, they ate well and slept soundly. So, I did get time for myself!

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

>Difficult Times

There are times when a parent needs more than just a few quiet moments. During a marriage breakdown or when there is a death in the family the question of adult-care and child-care is more fragile.

But, I believe that we still nee

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

to put the kids first because they just don’t have any of the adult resources or experience to help them deal with the crisis.

When I was a girl my mother died. My father found himself the single parent of four young daughters. He totally organized h

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

is life to look after us. He was there after school, he was available for us to talk about our concerns and fears in the evening. Mom was gone, but the parenting continued. Later, I learned that after we were settled for the night, he would go to the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ome of his best friend and unburden himself. It was an example of amazing parenting.

Needs and Wishes

So, let’s get back to talking about a middle-ground. The real problem comes when a parent doesn’t look after herself at all. Putting kids fi

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

rst doesn’t mean denying yourself the care you need. My dad cared for my sisters and me first. Then he looked after himself.

As I mentioned, when you care for your kids’ needs, you will have more time because you will have better-behaved and happier k

.

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

ds. But there is a difference between their needs and their wishes. My kids needed all the values they got from trips to the park when they were little. They might have wished to gorge on junk food, race around the house wildly or have me catering to t

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

Companies that provide selfless information through particip

heir every desire, but it didn’t happen. That wasn’t a need.

It’s all about balance. There will be times when you sacrifice or delay your needs to look after your kids. But the pay-off is happier and healthier kids. And isn’t that what we really want

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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