References - Home and Family

It's one of the cutest images most of us have of little girls - playing with their dolls, having doll tea parties and putting their dolls to bed in their own little bassinet. I had a bassine

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

t for my dolls when I was little too, and got countless hours of enjoyment out of playing with it - although I was bit keener on teddy bears than dolls! Eventually I grew older, the bassinet

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

Examples of combination products may in

fell apart and got thrown away, but the memories remained.

When I was pregnant with my first child, I was fortunate to discover that my eldest sister had kept a lot of her baby stuff, stack

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

ed up in her shed, for over 10 years. We pulled it all out, cleaned it up, and I set up the nursery for my own baby. At first I wasn't really sure about the bassinet, I thought it was a bit

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

unnecessary - after all, my sister had given me a perfectly good crib. But she told me I'd find it more helpful than I realised, so I set it up anyway.

My baby's arrival was early and drama

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

Combination pro

tic, and he was kept at the hospital for almost a month. It was an extremely difficult time, and when he came home, although he was very healthy, he was also still very tiny. So I worried e

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

ndlessly about him. Being a mother for the first time is scary enough, but it's even scarier when your baby is small enough to be mistaken for a doll.

So when it came to putting baby to sle

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

ep, I admit it - I didn't like him being in another room. Yes, I had a baby monitor, and during the day I used that when he had a nap, but at night I was always worried that something might

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

go wrong and I might lose him. I also found it frustrating to go through the whole process of slippers, dressing gown, going up to his room and so on. Being so small he didn't have a lot of

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

strength and his feeds took ages. By the time we were done, I was always wide-awake. So propping myself up in bed to feed him was a lot warmer, more comfortable, and I could still manage t

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

o stay half asleep while he fed!

It didn't take long for me to realise that having a bassinet with wheels on it meant that I could wheel it into our room at night, and have my baby right bes

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

Following aspects would a

ide the bed. I had considered co sleeping, but with him being so small I really wasn't keen on the idea. The bassinet really was the perfect solution. Whenever he woke up, I could lift him

dd to the challenges in developing combination products:

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

straight into bed for a feed, or do a quick diaper change on the bed before hopping back in for a feed. There was something very peaceful about curling up in bed feeding my baby, and I foun

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

d it much easier to go back to sleep when he was finished and tucked back up in the bassinet again.

I gained enormous peace of mind, having baby so close, but at the same time he was cosy an

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

d safe in his own little sleeping place. Gradually, as he slept longer and needed less attention, I moved the bassinet to the end of the bed, and eventually back into his room. He slept in

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

it right up to the point where he started discovering how to sit up, and I moved him into his crib.

There were some other really helpful things about the bassinet. I'd had a caesarean, so b

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

Professional from academic institutions, pharmaceutical industries, health care indust

ending was difficult for a while. The bassinet was much higher than the crib, and so it was much easier for me to lift baby in and out because I didn't have to bend over at all. I could als

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

o release the brake and then rock the bassinet gently back and forth - very useful if he was having a bit of trouble settling down for a nap. Some of the modern ones even have a light vibrat

.

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

ion feature, so the soothing work is done for you!

When my daughter came along, she also started her life sleeping in the bassinet, and it was just as useful for her too. Nowadays I find it

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

Companies that provide selfless information through particip

extra special when I watch her playing with her own dolls and bassinet. Life can get so busy in the modern world, that there's something almost magical in watching such a timeless activity.

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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